Eric R. Sokol, MD

All Publications

• Iltamiocel Autologous Cell Therapy for the Treatment of Female Stress Urinary Incontinence: A Double-Blind, Randomized, Stratified, Placebo-Controlled Trial. Neurourology and urodynamics Kaufman, M. R., Goldman, H. B., Chermansky, C. J., Dmochowski, R., Kennelly, M. J., Peters, K. M., Quiroz, L. H., Bennett, J. B., Thomas, S., Marguet, C. G., Benson, K. D., Lee, U. J., Sokol, E. R., Wolter, C. E., Katz, D. M., Tarnay, C. M., Antosh, D., Heit, M. H., Rehme, C., Karram, M., Snyder, S., Canestrari, E., Jankowski, R. J., Chancellor, M. B. 2024

  Abstract

  This study aimed to determine the efficacy and safety of iltamiocel investigational autologous muscle cell therapy in females with stress urinary incontinence (SUI).Adult females were randomized 2:1 to iltamiocel (150 × 106 cells) or placebo and stratified by severity and prior SUI surgery. The primary objective was efficacy based on the frequency of stress incontinence episodes (SIE) recorded in a 3-day diary at 12 months posttreatment. After 12 months, placebo participants could elect to receive open-label iltamiocel. Efficacy and safety analyses were performed using all patients as treated populations.The study enrolled 311 patients, 297 were randomized to either iltamiocel (n = 199) or placebo (n = 98). Of the 295 participants that completed 12 months blinded follow-up, the proportion achieving the primary endpoint of ≥ 50% SIE reduction was not statistically different between treatment groups (52% vs. 53.6%; p = 0.798). A significantly greater proportion of iltamiocel participants in the prior SUI surgery stratum group achieved ≥ 75% SIE reduction compared with placebo, (40% vs. 16%; p = 0.037). Treatment response was maintained at 24 months in 78.4% and 64.9% of iltamiocel participants who achieved ≥ 50% and ≥ 75% SIE reduction, respectively, at Month 12. Adverse events related to the treatment were reported in 19 (9.5%) iltamiocel participants and 6 (6.1%) placebo participants.The study did not meet its primary endpoint however, iltamiocel cell therapy is safe and may be ideally suited to female patients who have undergone prior surgery for SUI. Additional study in this group of patients with high unmet medical needs is warranted.ClinicalTrials.gov identifier: NCT01893138; EudraCT number: 2014-002919-41.

  View details for DOI 10.1002/nau.25588

  View details for PubMedID 39282854

• Transvaginal mesh versus native tissue repair for anterior and apical pelvic organ prolapse. Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC Sokol, E. R., Tu, L. M., Thomas, S. L., Erickson, T. B., Roovers, J. W. 2024: 102658

  Abstract

  This prospective comparative cohort study aims to evaluate the safety and efficacy of transvaginal mesh compared to native tissue repair (NTR) in the surgical correction of anterior and apical compartment pelvic organ prolapse (POP) over a 36-month follow-up period.Prospective comparative cohort study to prove superiority for efficacy and non-inferiority for serious adverse events (SAEs). The setting was 49 sites across the United States, Canada, Europe, and Australia. Women with bothersome POP symptoms indicated for vaginal surgery with POP-Q scores of Ba ≥0 and C≥ -1/2 TVL were included. Interventions included vaginal NTR or single-incision transvaginal mesh based on shared decision making. POP recurrence, the primary efficacy endpoint, was defined as anatomical prolapse beyond the hymenal ring, subjective perception of protrusion or bulge, or retreatment in the target compartment. The primary safety endpoint consisted of the proportion of device and/or procedure-related SAEs in the target compartment. Secondary endpoints included surgical parameters, quality of life, postoperative pain, and sexual function.POP recurrence rate at 12 months was 13.1% in the Mesh-arm and 11.5% in the NTR-arm (P = 0.44). The primary safety endpoint was met, with the Mesh-arm demonstrating statistically non-inferior outcomes compared to the NTR-arm in the incidence of device and/or procedure-related SAEs in the target compartment through 12 months (P < 0.01). At 36-months, the surgical POP recurrence rate was 26.7% in the Mesh-arm and 27.0% in the NTR-arm.At 12- and 36-month follow-up, transvaginal mesh was not superior, but non-inferior in terms of efficacy and safety when compared to native tissue repair for patients with combined anterior and apical compartment prolapse.

  View details for DOI 10.1016/j.jogc.2024.102658

  View details for PubMedID 39260621

• Pilot Study of a Novel At-Home Posterior Tibial Nerve System for Overactive Bladder Syndrome. Urogynecology (Philadelphia, Pa.) Burton, C. S., Sokol, E. R. 2024; 30 (2): 107-113

  Abstract

  Urgency urinary incontinence and overactive bladder are common conditions. Third-line therapies are often underutilized because of either being too invasive or being burdensome for the patient.We aimed to determine the efficacy and acceptability of a noninvasive, home-based posterior tibial nerve treatment system for the treatment of overactive bladder syndrome.In this pilot study, 10 postmenopausal women with urgency urinary incontinence were given the SoleStim System for home-based posterior tibial nerve stimulation. Symptoms at baseline and completion of the 8-week study were determined by 3-day voiding diary and quality-of-life questionnaire (Overactive Bladder Questionnaire) to assess for reduction in incontinence episodes.All patients were 100% adherent to the SoleStim System application over the 8-week period and reported statistically significant reductions in the mean number of voids (-16.3%, P = 0.022), urgency episodes (-31.2%, P = 0.02), and urgency urinary incontinence episodes (-31.4%, P = 0.045). Forty percent of participants reported a decrease of ≥50% in their urgency urinary incontinence episodes. SoleStim was scored a value of 1.8 ± 2.0 (mean ± SD) on a 10-point usability scale, indicating that it was highly acceptable from an ease-of-use perspective. No adverse events were reported.The SoleStim System improved key overactive bladder (frequency, urgency, and urgency urinary incontinence episodes) and quality-of-life metrics. The results from this pilot study suggest that the SoleStim System may be a safe, effective, and highly acceptable at-home overactive bladder therapy.

  View details for DOI 10.1097/SPV.0000000000001399

  View details for PubMedID 37493289

  View details for PubMedCentralID PMC10805982

• Urethral Bulking With Polyacrylamide Hydrogel Compared With Other Treatments for Stress Urinary Incontinence: A Cost-Effectiveness Analysis. Obstetrics and gynecology Chang, O. H., Shepherd, J. P., Cadish, L. A., Wallace, S. L., St Martin, B., Sokol, E. R. 2024

  Abstract

  Our objective was to perform a cost-effectiveness analysis comparing polyacrylamide hydrogel urethral bulking with other surgical and nonsurgical treatments for stress urinary incontinence (SUI). We created a cost-effectiveness analysis using TreeAge Pro, modeling eight SUI treatments. Treatment with midurethral sling (MUS) had the highest effectiveness (1.86 quality-adjusted life-years [QALYs]), followed by polyacrylamide hydrogel (1.82 QALYs), with a difference (Δ 0.02/year) less than the minimally important difference for utilities of 0.03 annually. When the proportion of polyacrylamide hydrogel urethral bulking procedures performed in the office setting is greater than 58%, polyacrylamide hydrogel is a cost-effective treatment for SUI, along with pessary, pelvic floor physical therapy, and MUS. Although MUS is more effective and, therefore, the preferred SUI treatment, polyacrylamide hydrogel is a reasonable alternative depending on patient preferences and treatment goals.

  View details for DOI 10.1097/AOG.0000000000005503

  View details for PubMedID 38207326

• Vaginal hysteropexy compared with vaginal hysterectomy with apical suspension for the treatment of pelvic organ prolapse: A 5-year cost-effectiveness Markov model. BJOG : an international journal of obstetrics and gynaecology Wallace, S. L., Syan, R., Lee, K., Sokol, E. R. 2023

  Abstract

  Our objective was to perform a 5-year cost-effectiveness analysis of transvaginal hysteropexy (HP) via sacrospinous ligament fixation (SS) or uterosacral ligament suspension (US) versus vaginal hysterectomy (VH) with apical suspension via sacrospinous ligament fixation (SS) or uterosacral ligament suspension (US) for the treatment of uterine prolapse.A decision analytic model assessed the cost-effectiveness of the surgical intervention over a 5-year horizon.This model was constructed using TreeAge® software.Healthy women undergoing surgery for uterine prolapse were modeled.A Markov model was constructed to simulate the possible recurrence of prolapse. Recurrence rates, repeat surgery for surgical failures and complication rates were modeled. Base case, sensitivity analyses and probabilistic modeling were performed.The primary outcome was the incremental cost-effectiveness ratio (ICER) of <$100 000 per quality-adjusted life year (QALY).Using the available prolapse recurrence rates and repeat surgery rates in the literature, both HP-SS and HP-US are cost-effective at a willingness-to-pay (WTP) threshold of <$100 000 per QALY. The incremental cost-effectiveness ratio (ICER) for HP-US compared to HP-SS is $90 738.14, while VH-US and VH-SS are both dominated strategies. HP-US is the optimal cost-effective strategy but decays exponentially with increasing probability of prolapse recurrence and need for repeat surgery after failed hysteropexy. The cost-effectiveness acceptability curve (CEAC) favors sacrospinous hysteropexy until reaching a WTP threshold between $90 000 and $100 000.Hysteropexy surgical strategies are cost-effective transvaginal surgical approaches for uterine prolapse. Vaginal hysterectomy with apical suspension becomes more cost-effective with increasing probability of prolapse recurrence and need for repeat surgery after failed hysteropexy. Given the variability of prolapse recurrence rates in the literature, more comparative studies are needed to understand the cost-effectiveness relationship between these different surgical approaches.

  View details for DOI 10.1111/1471-0528.17642

  View details for PubMedID 37667669

• Surgical correction of the genital hiatus at the time of sacrocolpopexy - a 7-year Markov analysis: a cost-effectiveness analysis. International urogynecology journal Chang, O. H., Shepherd, J. P., St Martin, B., Sokol, E. R., Wallace, S. 2023

  Abstract

  To perform a cost-effectiveness analysis of concurrent posterior repair performed at the time of laparoscopic hysterectomy with sacrocolpopexy over a 7-year time period. We hypothesize it is not cost-effective to perform a posterior colporrhaphy.We used TreeAge Pro® to construct a decision model with Markov modeling to compare sacrocolpopexy with and without concurrent posterior repair (SCP and SCP+PR) over a time horizon of 7 years. Outcomes included probability and costs associated with prolapse recurrence, prolapse retreatment, and complications including rectal injury, rectovaginal hematoma requiring reoperation, and postoperative dyspareunia. Cost-effectiveness was defined as an incremental cost-effectiveness ratio (ICER) calculated as ∆ costs /∆ effectiveness and the willingness to pay (WTP) was set at $100,000/QALY.Our model showed that SCP was the dominant strategy, with lower costs (-$ 2681.06) and higher effectiveness (+0.10) compared to SCP+PR over the 7-year period. In two-way sensitivity analyses, we varied the probability of prolapse recurrence after both strategies. Our conclusions would only change if the probability of recurrence after SCP was at least 29.7% higher than after SCP+PR. When varying the probabilities of dyspareunia for both strategies, SCP+PR only became the dominant strategy if the probability of dyspareunia for SCP+PR was lower than the rate of SCP alone.In this 7-year Markov cost-effectiveness analysis, SCP without concurrent PR was the dominant strategy. SCP+PR costs more with lower effectiveness than SCP alone, due to higher surgical cost of SCP+PR and higher probability of dyspareunia after SCP+PR.

  View details for DOI 10.1007/s00192-023-05628-9

  View details for PubMedID 37650903

  View details for PubMedCentralID 3244827

• Light and energy-based therapeutics for genitourinary applications: Consensus on protocols and best practices. Lasers in surgery and medicine Alexiades, M. R., Iglesias, C., Sokol, E., Gaspar, A., Tadir, Y. 2023

  Abstract

  BACKGROUND: Lasers and energy-based technologies have been developed for genitourinary applications over the past several decades.AIMS: This consensus article aims to categorize the published articles and clinical trial data that culminated in protocol development of technology for genitourinary applications, and to develop consistent parameters in future clinical trials.MATERIALS AND METHODS: The published articles and clinical trials data on lasers and energy-based devices applied to genitourinary conditions were categorized according to device and condition and consensus developed on protocols and parameters.RESULTS: The devices in genitourinary applications were classified as fractional lasers, radiofrequency and high-intensity focused electromagnetic field therapy. The consensus of the protocols and parameters based upon the published clinical trials of their application to the vaginal and urologic conditions associated with genitourinary syndrome of menopause was developed and organized according to device and condition.DISCUSSION: The status of FDA clearances and future pathways are discussed.CONCLUSIONS: This consensus article categorizes and presents the protocols and practices for the main classes of lasers and energy-based devices for genitourinary applications in future clinical trials.

  View details for DOI 10.1002/lsm.23672

  View details for PubMedID 37130435

• Can pelvic organ prolapse volume calculation via mri defecography be clinically useful in patients with rectal prolapse? Khorsandi, S., Sheth, V. R., Chow, A., Lang, T., Sokol, E. R. MOSBY-ELSEVIER. 2023: S894-S895

  View details for Web of Science ID 000974044200136

• BETA-3-AGONISTS ARE PREFERRED VERSUS ANTICHOLINERGICS FOR OVERACTIVE BLADDER: A 10-YEAR MICROSIMULATION COST-EFFECTIVENESS ANALYSIS St Martin, B., Wallace, S., Cadish, L., Chang, O., Park, A., Sokol, E., Shepherd, J. WILEY. 2023: S94-S96

  View details for Web of Science ID 001043021100098

• Clinical Consensus Statement: Vaginal Energy-Based Devices OBSTETRICAL & GYNECOLOGICAL SURVEY Alshiek, J., Garcia, B., Minassian, V., Iglesia, C. B., Clark, A., Sokol, E. R., Murphy, M., Malik, S. A., Kimble, A., Shobeiri, S. 2023; 78 (1): 23-25

  View details for DOI 10.1097/01.ogx.0000912600.82471.e4

  View details for Web of Science ID 000916521100010

• Clinical Consensus Statement: Vaginal Energy-Based Devices. Urogynecology (Hagerstown, Md.) Alshiek, J., Garcia, B., Minassian, V., Iglesia, C. B., Clark, A., Sokol, E. R., Murphy, M., Malik, S. A., Kimble, A., Shobeiri, S. A. 2022; 28 (10): 633-648

  Abstract

  ABSTRACT: This clinical consensus statement on vaginal energy-based devices (EBDs) reflects an update by content experts from the American Urogynecologic Society's EBD writing group. In 2019, the American Urogynecologic Society's EBD writing group used a modified Delphi process to assess statements that were evaluated for consensus after a structured literature search. A total of 40 statements were assessed and divided into 5 categories: (1) patient criteria, (2) health care provider criteria, (3) efficacy, (4) safety, and (5) treatment considerations. Of the 40 statements that were assessed, 28 reached consensus and the remaining 12 did not. Lack of evidence was among the main reasons that vulvovaginal EBD treatment statements did not reach consensus. In March 2022, these statements were reassessed using the interim literature.

  View details for DOI 10.1097/SPV.0000000000001241

  View details for PubMedID 36256959

• Cost-effectiveness of Urethral Bulking with Polyacrylamide Hydrogel Compared to Other Treatments for Stress Urinary Incontinence Chang, O., Shepherd, J., Cadish, L., Wallace, S., St Martin, B., Sokol, E. SPRINGER LONDON LTD. 2022: S278

  View details for Web of Science ID 000874059800139

• Postoperative Complications and Pelvic Organ Prolapse Recurrence Following Combined Rectal Prolapse and Pelvic Organ Prolapse Surgery Compared to Pelvic Organ Prolapse Surgery Only Wallace, S., Kim, Y., Lai, E., Mehta, S., Gaigbe-Togbe, B., Zhang, C. A., von Bargen, E. C., Sokol, E. R. SPRINGER LONDON LTD. 2022: S228-S229

  View details for Web of Science ID 000874059800074

• Postoperative Complications and Pelvic Organ Prolapse Recurrence Following Combined Pelvic Organ Prolapse and Rectal Prolapse Surgery Compared to Pelvic Organ Prolapse Only Surgery. American journal of obstetrics and gynecology Wallace, S. L., Kim, Y., Lai, E., Mehta, S., Gaigbe-Togbe, B., Zhang, C. A., Von Bargen, E. C., Sokol, E. R. 2022

  Abstract

  BACKGROUND: There is a growing interest in combined pelvic organ prolapse (POP) and rectal prolapse (RP) surgery for concomitant pelvic floor prolapse despite a paucity of data regarding complications and clinical outcomes of combined repair.OBJECTIVE: The primary objective of this study was to compare the <30-day postoperative complication rate in women undergoing combined POP+RP surgery to those undergoing POP-only surgery. The secondary objectives were to describe the <30-day postoperative complications, to compare POP recurrence between the two groups and to determine preoperative predictors of <30-day postoperative complications and predictors of POP recurrence.STUDY DESIGN: This was a multicenter, retrospective cohort study at five academic hospitals. Patients undergoing combined POP+RP surgery were matched by age, POP stage by leading compartment and POP procedure to those undergoing POP-only surgery from March 2003 to March 2020. The primary outcome measure was <30-day complications separated into Clavien-Dindo (CD) classes. Secondary outcome measures were 1) subsequent POP surgeries and 2) POP recurrence, defined as patients who complained of vaginal bulge symptoms postoperatively.RESULTS: Two hundred and four women underwent combined surgery for POP+RP and 204 women underwent surgery for POP-only. Average age (59.3+1.0 vs 59.0+1.0) and mean parity (2.3+1.5 vs 2.6+1.8) was similar in each group. One hundred and nine patients (26.7%) had at least one <30-day postoperative complication. The proportion of patients who had a complication in the combined group and POP-only group was similar (27.5% vs 26.0%, p=0.82). CD scores were similar between the groups (10.3% vs 9.3% Grade 1, 11.8% vs 12.3% Grade 2, 3.9% vs 4.4% Grade 3, 1.0% vs 0% Grade 4, 0.5% vs 0% Grade 5). Combined patients were less likely than POP-only patients to develop postoperative UTIs and urinary retention but were more likely to be treated for wound infections and pelvic abscesses. After adjusting for combined vs POP-only surgery and parity, patients who had anti-incontinence procedures (aOR=1.85, 95% CI 1.16, 2.94, p=0.02) and perineorrhaphies (aOR=1.68, 95% CI 1.05, 2.70, p=0.02) were more likely to have <30-day postoperative complications. Twelve patients in the combined group and 15 patients in the POP-only group (5.9% vs 7.4%, p=0.26) had subsequent POP repairs. In the combined group, 10 patients (4.9%) underwent one repair and 2 patients (1.0%) underwent two repairs. All patients who had recurrent POP surgery in the POP-only group had one subsequent POP repair. Twenty-one patients in the combined surgery group and 28 patients in the POP-only group (10.3% vs 13.7%, p=0.26) reported recurrent POP. On multivariable analysis adjusted for number of prior POP repairs, combined vs POP-only group and perineorrhaphy at the time of surgery, patients were more likely to have a subsequent POP surgery if they had had 2 or more prior POP repairs (aOR=6.06, 95% CI 2.10, 17.5, p=0.01). Average follow-up time was 307.2+31.5 days for the combined cohort and 487.7+49.9 days for the POP-only cohort. Survival curves indicated that the median time-to-recurrence was not statistically significant (log rank, p=0.265) between the combined group (4.2+0.4 years) and POP-only group (5.6+0.4 years).CONCLUSION: In this retrospective cohort study, patients undergoing combined POP+RP surgery had a similar risk of <30-day postoperative complications compared to patients undergoing POP-only surgery. Combined patients also had a similar risk of recurrent POP and subsequent POP surgery compared to patients undergoing POP-only surgery.

  View details for DOI 10.1016/j.ajog.2022.05.050

  View details for PubMedID 35654113

• Long-Term Outcomes After Vaginal and Laparoscopic Mesh Hysteropexy for Uterovaginal Prolapse: A Parallel Cohort Study (eVAULT). Female pelvic medicine & reconstructive surgery Fitzgerald, J. J., Sokol, E. R., Rardin, C. R., Cundiff, G. W., Paraiso, M. F., Chou, J., Gutman, R. E. 2022

  Abstract

  IMPORTANCE: Data on long-term mesh hysteropexy outcomes are limited. This study provides 7-year data from the original VAULT (Vaginal and Laparoscopic Mesh Hysteropexy for Uterovaginal Prolapse Trial) study.OBJECTIVE: The aim of this study was to compare long-term outcomes and success for laparoscopic sacral hysteropexy (LSHP) and vaginal mesh hysteropexy (VMHP).STUDY DESIGN: This multicenter, prospective parallel cohort was an extension to the initial VAULT study. Subjects were contacted, and informed consent was obtained. We collected baseline demographics and the latest Pelvic Organ Prolapse-Quantification examination data from chart review and conducted telephone interviews to update demographic information and collect Pelvic Floor Distress Inventory Short-Form, Patient Global Impression of Improvement, prolapse reoperation/pessary use, and complications. Surgical success was defined as no bulge symptoms, satisfaction score of "very much better" or "much better," and no reoperation/pessary use.RESULTS: Five of 8 original sites enrolled 53 subjects (LSHP n = 34 and VMHP n = 19). The LSHP group was younger (67 vs 74, P < 0.01), but there were no differences in parity, body mass index, menopause, race, insurance, tobacco use, or Charlson Comorbidity Index. The median subjective follow-up was 7.3 ± 0.9 years. Composite success was 82% LSHP versus 74% VMHP. Pelvic Floor Distress Inventory Short-Form composite scores were similar at baseline and improved for both groups (P < 0.01) with lower bother observed in the LSHP group (20.8 vs 43.8, P = 0.01). There were no differences in complications.CONCLUSIONS: Over 7 years after surgery, LSHP and VMHP have high success, low retreatment, and low complication rates that did not differ between groups. Although there is a trend toward better anatomic support in the LSHP group, these findings were not significant and we are underpowered to detect a difference.

  View details for DOI 10.1097/SPV.0000000000001188

  View details for PubMedID 35536663

• Surgical correction of the genital hiatus at the time of sacrocolpopexy - a 7-year markov analysis Chang, O. H., Shepherd, J. P., Martin, B., Sokol, E. R., Wallace, S. L. MOSBY-ELSEVIER. 2022: S1291

  View details for Web of Science ID 000759637700041

• Postoperative complications and pelvic organ prolapse recurrence following combined rectal prolapse and pelvic organ prolapse surgery compared to pelvic organ prolapse surgery only Wallace, S. L., Kim, Y., Lai, E., Mehta, S., Gaigbe-Togbe, B., Zhang, C., Von Bargen, E. C., Sokol, E. R. MOSBY-ELSEVIER. 2022: S1274-S1275

  View details for Web of Science ID 000759637700014

• Surgical Correction of the Genital Hiatus at the Time of Sacrocolpopexy-Are Concurrent Posterior Repairs Cost-Effective? Female pelvic medicine & reconstructive surgery Chang, O. H., Shepherd, J. P., St Martin, B., Sokol, E. R., Wallace, S. 2022

  Abstract

  OBJECTIVE: The objective was to perform a cost-effectiveness analysis of posterior repair performed at the time of sacrocolpopexy (SCP).METHODS: We used TreeAge Pro to construct a decision model comparing laparoscopic hysterectomy with SCP with and without concurrent posterior repair (SCP and SCP + PR). Using a time horizon of 1 year, we modeled prolapse recurrence, prolapse retreatment, and complications, including rectal injury, rectovaginal hematoma requiring surgical take-back, and postoperative dyspareunia. Costs included index surgery, surgical retreatment, and complications. We modeled effectiveness as quality-adjusted life years (QALYs). Cost-effectiveness was defined using the incremental cost-effectiveness ratio and willingness to pay of $100,000/QALY. Sensitivity analyses were performed.RESULTS: Sacrocolpopexy was the dominant strategy with a cost of $65,714 and an effectiveness of 0.84. It was cost-effective at willingness to pay threshold less than $100,000/QALY. The SCP + PR costs more ($75,063) with lower effectiveness (0.83). The effectiveness of the 2 strategies was similar, differing only by 0.01 QALY, which is less than the minimally important difference for utilities. Tornado plots showed CEA results were most influenced by the cost of SCP, cost of SCP + PR, and probability of dyspareunia after SCP. In 1-way sensitivity analyses, the model outcome would change only if the cost of SCP was increased by 12.8% or if the cost of SCP + PR decreased by 14.5%. For dyspareunia, our model would only change if the probability of dyspareunia after SCP alone was 75.9% (base case, 18.6%), whereas the probability of dyspareunia after SCP + PR was 26.8%.CONCLUSION: In this cost-effectiveness analysis, SCP without concurrent PR was the dominant strategy.

  View details for DOI 10.1097/SPV.0000000000001130

  View details for PubMedID 35234184

• SAFETY, EFFICACY, AND QUALITY OF LIFE IMPROVEMENT IN WOMEN WITH PRIOR STRESS INCONTINENCE SURGERY TREATED WITH AUTOLOGOUS MUSCLE DERIVED CELLS: EXPERIENCE FROM TWO DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIALS Dmochowski, R., Goldman, H., Lee, U., Carr, L., Peters, K., Benson, K., Thomas, S., Tu, L., Bennett, J., Heit, M., Quiroz, L., Chermansky, C., Kennelly, M., Sokol, E., Antosh, D., Wolter, C., Jankowski, R., Carlson, C., Cardello, K., Chancellor, M., Kaufman, M. WILEY. 2021: S105-S106

  View details for Web of Science ID 000672054400067

• Surgical correction of the genital hiatus at the time of sacrocolpopexy - are concurrent posterior repairs cost-effective? Chang, O. H., Shepherd, J. P., St Martin, B., Sokol, E. R., Wallace, S. MOSBY-ELSEVIER. 2021: S726-S727

  View details for Web of Science ID 000655520200005

• Cost-effectiveness of vaginal hysteropexy compared to vaginal hysterectomy with apical suspension for the treatment of pelvic organ prolapse: A 5-year markov model Wallace, S. L., Syan, R., Lee, K., Sokol, E. R. MOSBY-ELSEVIER. 2021: S736-S737

  View details for Web of Science ID 000655520200018

• COST-EFFECTIVENESS OF TRANSVAGINAL HYSTEROPEXY COMPARED TO VAGINAL HYSTERECTOMY WITH APICAL SUSPENSION FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE: A 5-YEAR MARKOV MODEL Wallace, S., Syan, R., Lee, K., Sokol, E. WILEY. 2021: S65–S67

  View details for Web of Science ID 000635690300075

• Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence. Neurourology and urodynamics Brosche, T., Kuhn, A., Lobodasch, K., Sokol, E. R. 2021

  Abstract

  AIMS: Bulking agents are a minimally invasive treatment option for women with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (MUI). The aim of this study was to evaluate long-term efficacy and safety following treatment with Bulkamid as a primary procedure for SUI or stress-predominant MUI.METHODS: This was an Institutional Review Board-approved single-center retrospective study of female patients with SUI or stress-predominant MUI who had undergone injection with Bulkamid since 2005 and had completed 7 years of follow up. The primary endpoint was patient satisfaction measured on a four-point scale as cured, improved, unchanged, or worse. Secondary outcomes included the number of incontinence pads used, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI SF) scores, Visual Analog Scale Quality of Life (VAS QoL), reinjection rates, and perioperative and postoperative complications.RESULTS: A total of 1,200 patients were treated with Bulkamid since 2005 and of these, 388 (32.3%) had completed 7 years of follow-up. A total of 67.1% of the patients reported feeling cured or improved if Bulkamid was a primary procedure, 11.1% reported no change, and 2.3% reported worsening of incontinence. A total of 19.5% of patients received a subsequent other incontinence procedure. The ICIQ-UI SF was reduced by 8.6 points. VAS QoL improved by a mean of 4.3 points. Postoperative complications were transient. Prolonged bladder emptying time was reported in 15.3% of patients and urinary tract infection in 3.5%.CONCLUSIONS: Bulkamid injections are an effective and safe first-line treatment option for women with SUI or stress-predominant MUI providing durable outcomes at 7 years.

  View details for DOI 10.1002/nau.24589

  View details for PubMedID 33410544

• Postoperative complications and recurrence rates after rectal prolapse surgery versus combined rectal prolapse and pelvic organ prolapse surgery. International urogynecology journal Wallace, S. L., Enemchukwu, E. A., Mishra, K. n., Neshatian, L. n., Chen, B. n., Rogo-Gupta, L. n., Sokol, E. R., Gurland, B. H. 2021

  Abstract

  Our primary objectives were to compare < 30-day postoperative complications and RP recurrence rates after RP-only surgery and combined surgery. Our secondary objectives were to determine preoperative predictors of < 30-day complications and RP recurrence.A prospective IRB-approved cohort study was performed at a single tertiary care center from 2017 to 2020. Female patients with symptomatic RP underwent either RP-only surgery or combined surgery based on the discretion of the colorectal and FPMRS surgeons. Primary outcome measures were < 30-day complications separated into Clavien-Dindo (CD) classes and rectal prolapse on physical examination.Seventy women had RP-only surgery and 45 had combined surgery with a mean follow-up time of 208 days. Sixty-eight percent underwent abdominal RP repair, and 32% underwent perineal RP repair. Twenty percent had one or more complications, 14% in the RP-only group and 29% in the combined surgery group (p = 0.06). On multivariate analysis, combined surgery patients had a 30% increased risk of complications compared to RP-only surgery patients (RR = 1.3). Most of these complications were minor (14/17, 82.4%) and categorized as CD I or II, including urinary retention and UTI. Twelve percent of this cohort had RP recurrence, 11% in the RP-only group and 13% in the combined surgery group (p = 0.76). Preoperative risk factors for RP recurrence included a primary complaint of rectal bleeding (RR 5.5) and reporting stools consistent with Bristol Stool Scale of 1 (RR 2.1).Patients undergoing combined RP + POP surgery had a higher risk of complications and equivalent RP recurrence rates compared to patients undergoing RP-only surgery.

  View details for DOI 10.1007/s00192-021-04778-y

  View details for PubMedID 33864476

• A COST-EFFECTIVENESS ANALYSIS OF VAGINAL HYSTEROPEXY COMPARED TO VAGINAL HYSTERECTOMY WITH APICAL SUSPENSION FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE Wallace, S., Syan, R., Lee, K., Sokol, E. WILEY. 2020: S194–S195

  View details for Web of Science ID 000544770200134

• A cost-effectiveness analysis of hysteropexy compared to vaginal hysterectomy with apical suspension for the treatment of pelvic organ prolapse using a vaginal approach Syan, R., Wallace, S., Lee, K., Sokol, E. WILEY. 2020: S81–S82

  View details for Web of Science ID 000519661200096

• The transvaginal pelvic organ prolapse mesh ban - unfairly including biologic products? Elliott, C., Sokol, E., Rogo-Gupta, L. WILEY. 2020: S270

  View details for Web of Science ID 000519661200334

• Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports. Menopause (New York, N.Y.) Wallace, S. L., Sokol, E. R., Enemchukwu, E. A. 2020

  Abstract

  Energy-based devices have gained momentum as minimally invasive procedures to treat both medical and cosmetic pelvic floor disorders including genitourinary syndrome of menopause, vaginal laxity, stress urinary incontinence, dyspareunia, and vulvar disorders such as lichen diseases and vestibulitis. However, the FDA recently issued a statement cautioning patients and providers that the safety and efficacy of energy-based devices for the treatment of vaginal symptoms has not been well established. Additionally, the FDA sent letters to the manufactures of energy-based devices with notifications that they could be violating the marketing standards of the FDA. The existing data on side effects is insufficient and limited to observational studies. We sought to characterize the safety events of vaginal energy-based devices by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database and specifically look at those events that occurred prior to the July 30, 2018 warning.The MAUDE database was queried between September 30, 2013 and October 31, 2019 for all vaginal energy-based devices. The incidence of safety events was reported for these devices and the most common complaints were described and characterized. Event reporting was analyzed before and after July 30, 2018.Forty-two unique and relevant medical device reports (MDRs) were retrieved. The Mona Lisa Touch had the highest number of MDRs (40.5%) followed by ThermiVa (16.7%) and Viveve (14.2%). Each medical device report was associated with a single patient experience and within the 42 medical device reports, there were 85 complaints. A majority of the MDR complaints (52.9%) were also indications for energy-based devices procedures, which include vaginal pain, dyspareunia, lichen sclerosis, and urinary frequency. Two-thirds of the complaints (68.2%) were related to pain, but serious adverse events such as third-degree burns (3.5%) were rare. Most of the reportable events occurred before July 30, 2018 (83.3%), but most were reported after July 30, 2018 (78.6%).MAUDE-reported data suggests that the majority of patient complaints after vaginal energy-based device treatment include vaginal pain, bladder pain, and urinary symptoms. This study suggests that the majority of complaints are not severe, and some may be related to progression of the disease. The few severe adverse events reported in the MAUDE database may have contributed to the FDA warning regarding energy-based devices. Recall bias after the FDA warning, as well as the potential for litigation, may have prompted an increase in adverse event reporting after July 30, 2018. : Video Summary:http://links.lww.com/MENO/A650.

  View details for DOI 10.1097/GME.0000000000001661

  View details for PubMedID 33003133

• Vaginal Energy-Based Devices. Female pelvic medicine & reconstructive surgery Alshiek, J. n., Garcia, B. n., Minassian, V. n., Iglesia, C. B., Clark, A. n., Sokol, E. R., Murphy, M. n., Malik, S. A., Tran, A. n., Shobeiri, S. A. 2020

  Abstract

  This clinical consensus statement on vaginal energy-based devices (EBDs) reflects statements drafted by content experts from the American Urogynecologic Society's EBD writing group. The American Urogynecologic Society's EBD writing group used a modified Delphi process to assess statements that were evaluated for consensus after a structured literature search. A total of 40 statements were assessed and divided into 5 categories: (1) patient criteria, (2) health care provider criteria, (3) efficacy, (4) safety, and (5) treatment considerations. Of the 40 statements that were assessed, 28 reached consensus and the remaining 12 did not. Lack of evidence was among the main reasons that vulvovaginal EBD treatment statements did not reach consensus.

  View details for DOI 10.1097/SPV.0000000000000872

  View details for PubMedID 32324684

• Surgical approach, complications, and reoperation rates of combined rectal and pelvic organ prolapse surgery. International urogynecology journal Wallace, S. L., Syan, R. n., Enemchukwu, E. A., Mishra, K. n., Sokol, E. R., Gurland, B. n. 2020

  Abstract

  Our primary objective was to determine rectal prolapse (RP) and pelvic organ prolapse (POP) reoperation rates and postoperative < 30-day complications after combined RP and POP surgery at a single institution.This was an IRB-approved retrospective cohort study of all female patients who received combined RP and POP surgery at a single tertiary care center from 2008 to 2019. Recurrence was defined as the need for subsequent repeat RP or POP surgery at any point after the index surgery. Surgical complications were separated into Clavien-Dindo classes.Sixty-three patients were identified, and 18.3% (12/63) had < 30-day complications (55% Clavien-Dindo grade 1; 27% Clavien-Dindo grade 2; 18% Clavien-Dindo grade 4). Of patients undergoing combined abdominal RP and POP repair, no postoperative < 30-day complications were noted in the MIS group compared to 37.5% of those patients in the laparotomy group (p < 0.01). Overall, in those patients who underwent combined RP and POP surgery, the need for subsequent RP surgery for recurrent RP was 14% and the need for subsequent POP surgery for recurrent POP was 4.8% (p = 0.25).In this cohort of women undergoing combined RP and POP surgery, a higher proportion required subsequent RP surgery compared to those requiring subsequent POP surgery, although this was not statistically significant. Almost one-fifth of patients undergoing combined RP and POP surgery experienced a < 30-day surgical complication, regardless of whether the approach was perineal or abdominal. For those patients undergoing abdominal repair, < 30-day complications were more likely in those patients who had a laparotomy compared to those who had a minimally invasive surgery.

  View details for DOI 10.1007/s00192-020-04394-2

  View details for PubMedID 32577789

• A COST-EFFECTIVENESS ANALYSIS OF VAGINAL CO2 LASER THERAPY COMPARED TO STANDARD MEDICAL THERAPIES FOR GENITOURINARY SYNDROME OF MENOPAUSE-ASSOCIATED DYSPAREUNIA. American journal of obstetrics and gynecology Wallace, S. L., Martin, B. S., Lee, K. n., Sokol, E. R. 2020

  Abstract

  Topical vaginal estrogen is considered the gold standard therapy for GSM-associated dyspareunia, but early investigations of energy-based devices show promise for patients with contraindications or who are refractory to vaginal estrogen cream. While evaluating safety, efficacy and long-term outcomes for novel technologies is critically important when new technologies become available to treat unmet healthcare needs, evaluation of the costs of these new technologies compared to existing therapies is also critically important, but often understudied.We sought to perform a cost-effectiveness analysis of three therapies for GSM including vaginal estrogen, oral ospemifene and vaginal CO2 laser therapy and determine if vaginal laser therapy is a cost-effective treatment for dyspareunia associated with GSM.An IRB-exempt cost-effectiveness analysis was performed by constructing a decision tree using decision analysis software (TreeAge Pro; TreeAge Software, Inc., Williamstown, MA) using integrated empirical data from the published literature. Tornado plots, one-way and two-way sensitivity analyses were performed to assess how changes in the model's input parameters altered the overall outcome of the cost-effectiveness model.All three treatment methods were found to be cost-effective below the WTP threshold of $50,000 per QALY for moderate dyspareunia. The ICER for vaginal CO2 laser treatment of moderate dyspareunia was $16,372.01 and the ICER for ospemifene was $5,711.14. Although all three treatment strategies were on the efficient frontier, vaginal CO2 laser treatment was the optimal strategy with the highest effectiveness. In a one-way sensitivity analysis of treatment adherence, the vaginal CO2 laser was no longer cost effective when the adherence fell below 38.8%. Vaginal estrogen cream and ospemifene remained cost-effective strategies at all ranges of adherence. When varying the adherence to 100% for all strategies, oral ospemifene was "dominated" by both vaginal fractional CO2 laser therapy and vaginal estrogen cream. In a two-way sensitivity analysis of vaginal CO2 laser adherence and vaginal CO2 laser cost, vaginal CO2 laser therapy still remained the optimal strategy at 200% of its current cost ($5,554.00) if the adherence was greater than 55%. If the cost fell to 20% of its current cost ($555.40), it was the optimal strategy at all adherence values above 29%.The present study showed that the vaginal fractional CO2 laser is a cost-effective strategy for the treatment of dyspareunia associated with GSM, as are vaginal estrogen and oral ospemifene. In our model, the vaginal CO2 laser is the optimal cost-effective strategy and consideration should be made to providing insurance coverage for this treatment option.

  View details for DOI 10.1016/j.ajog.2020.06.032

  View details for PubMedID 32562659

• A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: The VeLVET Trial. Menopause (New York, N.Y.) Paraiso, M. F., Ferrando, C. A., Sokol, E. R., Rardin, C. R., Matthews, C. A., Karram, M. M., Iglesia, C. B. 2019

  Abstract

  OBJECTIVE: The aim of the study was to compare 6-month efficacy and safety for treatment of vaginal dryness/genitourinary syndrome of menopause in women undergoing fractionated CO2 vaginal laser therapy to women using estrogen vaginal cream.METHODS: This multicenter, randomized trial compared fractionated CO2 laser to estrogen cream at 6 institutions. We included menopausal women with significant vaginal atrophy symptoms and we excluded women with prolapse below stage 2, recent pelvic surgery, prior mesh surgery, active genital infection, history of estrogen sensitive malignancy, and other autoimmune conditions. The primary outcome was the visual analog scale vaginal dryness score. Secondary outcomes included evaluation of vaginal atrophy, quality of life symptoms, assessment of sexual function, and urinary symptoms. Adverse events (AEs) and patient global impression of improvement (PGI-I) and satisfaction were also assessed.RESULTS: Sixty-nine women were enrolled in this trial before enrollment was closed due to the Federal Drug Administration requiring the sponsor to obtain and maintain an Investigational Device Exemption. Of the 69 participants enrolled, 62 completed the 6-month protocol; 30 women were randomized to the laser and 32 to estrogen cream from June 2016 to September 2017. Demographics did not differ between groups except the laser group was less parous (0 [range 0-4] vs 2 [0-6], P = 0.04). On patient global impression, 85.8% of laser participants rated their improvement as "better or much better" and 78.5% reported being either "satisfied or very satisfied" compared to 70% and 73.3% in the estrogen group; this was not statistically different between groups. On linear regression, mean difference in female sexual function index scores was no longer statistically significant; and, vaginal maturation index scores remained higher in the estrogen group (adj P value 0.02); although, baseline and 6-month follow-up vaginal maturation index data were only available for 34 participants (16 laser, 18 estrogen).CONCLUSIONS: At 6 months, fractionated CO2 vaginal laser and vaginal estrogen treatment resulted in similar improvement in genitourinary syndrome of menopause symptoms as well as urinary and sexual function. Overall, 70% to 80% of participants were satisfied or very satisfied with either treatment and there were no serious adverse events. : Video Summary:http://links.lww.com/MENO/A470.

  View details for DOI 10.1097/GME.0000000000001416

  View details for PubMedID 31574047

• A COST-EFFECTIVENESS ANALYS IS OF THE INTRAVAGINAL CO2 LASER THERAPY COMPARED TO STANDARD MEDICAL THERAPIES FOR GENITOURINARY SYNDROME OF MENOPAUSE St Martin, B. S., Wallace, S. L., Sokol, E. R. SPRINGER LONDON LTD. 2019: S60–S61

  View details for Web of Science ID 000488930400096

• SURGICAL APPROACH, COMPLICATIONS AND RECURRENCE AFTER COMBINED RECTAL PROLAPSE AND PELVIC ORGAN PROLAPSE SURGERY AT A SINGLE TERTIARY CARE CENTER FROM 2008 TO 2019 Wallace, S. L., Syan, R., Tran, A., Mishra, K., Sokol, E. R., Gurland, B. H. SPRINGER LONDON LTD. 2019: S262

  View details for Web of Science ID 000488930400481

• SURGICAL APPROACH, COMPLICATIONS AND RECURRENCE AFTER COMBINED RECTAL PROLAPSE AND PELVIC ORGAN PROLAPSE SURGERY AT A SINGLE TERTIARY CARE CENTER FROM 2008 TO 2019 Wallace, S., Syan, R., Tran, A., Gurland, B., Sokol, E., Mishra, K. WILEY. 2019: S324–S326

  View details for Web of Science ID 000477753000222

• Patient Characteristics that May Influence the Effect of Urethral Injection Therapy for Female Stress Urinary Incontinence JOURNAL OF UROLOGY Elmelund, M., Sokol, E. R., Karram, M. M., Dmochowski, R., Klarskov, N. 2019; 202 (1): 125–30

  View details for DOI 10.1097/JU.0000000000000176

  View details for Web of Science ID 000475857100085

• Alternative approaches to traditional rectal prolapse repair in conjunction with vaginal prolapse surgery Wallace, S. L., Sokol, E. R. MOSBY-ELSEVIER. 2019: S753–S754

  View details for DOI 10.1016/j.ajog.2019.01.104

  View details for Web of Science ID 000459453000091

• Patient characteristics that may influence the effect of urethral injection therapy in female stress urinary incontinence. The Journal of urology Elmelund, M., Sokol, E. R., Karram, M. M., Dmochowski, R., Klarskov, N. 2019: 101097JU0000000000000176

  Abstract

  PURPOSE: Urethral injection therapy is a well-known treatment of female stress urinary incontinence, but the optimal group of recipients has not been established. This study aims at examining which patient characteristics are associated with success after urethral injection therapy.MATERIALS AND METHODS: This study is a post hoc analysis of a previously published randomized, 33-center study of the hydrogel bulking agent Bulkamid vs the collagen gel Contigen. Regardless of the treatment, women were considered cured if there were no stress incontinence episodes on the bladder diary and no stress incontinence symptoms on International Consultation on Incontinence Questionnaire Urinary Incontinence short form, improved if there was ≥50% reduction in stress incontinence episodes and no effect if there was <50% reduction in stress incontinence episodes one year after treatment.RESULTS: Of the 345 women who were initially randomized, 291 women were included in this study. A total of 191 women received Bulkamid and 100 received Contigen. After one year, 74 (25%) were cured, 164 (56%) were improved and 53 (18%) had no effect. In a multivariate logistic regression analysis, age ≥60 years and <2.5 daily stress incontinence episodes were associated with cure. In this group, 90% had effect of the treatment and 38% were cured compared with a 13% cure-rate in women <60 years with ≥2.5 daily stress incontinence episodes.CONCLUSIONS: Urethral injection therapy is more effective for the treatment of stress urinary incontinence in women ≥60 years with <2.5 daily stress incontinence episodes and has a 90% success-rate in these women.

  View details for PubMedID 30810462

• Surgery for Apical Vaginal Prolapse after Hysterectomy Transvaginal Mesh-Based Repair UROLOGIC CLINICS OF NORTH AMERICA Wallace, S. L., Syan, R., Sokol, E. R. 2019; 46 (1): 103-+

  View details for DOI 10.1016/j.ucl.2018.08.005

  View details for Web of Science ID 000454469100013

• Advanced oab therapies are equally effective in untreated and treated pelvic organ prolapse patients Syan, R., Wallace, S. L., Torosis, M., Sokol, E. WILEY. 2019: S117

  View details for Web of Science ID 000462357800143

• Surgery for Apical Vaginal Prolapse after Hysterectomy: Transvaginal Mesh-Based Repair. The Urologic clinics of North America Wallace, S. L., Syan, R., Sokol, E. R. 2019; 46 (1): 103–11

  Abstract

  Several transvaginal mesh products have been marketed to address vaginal vault prolapse. Although data are limited, prolapse recurrence rates and subjective outcome measures seem to be equivalent for vaginal mesh compared with native tissue apical prolapse repair, and the different vaginal meshes have not proven superior to one another. Given the known unique complications specific to vaginal mesh with equivalent outcomes for the apical vaginal prolapse, it is reasonable to reserve mesh use for specific high-risk cases, such as patients with large apical prolapse recurrence after native tissue repair who are not candidates for sacrocolpopexy.

  View details for PubMedID 30466695

• Does the Degree of Cystocele Predict De Novo Stress Urinary Incontinence After Prolapse Repair? Further Analysis of the Colpopexy and Urinary Reduction Efforts Trial FEMALE PELVIC MEDICINE AND RECONSTRUCTIVE SURGERY Davenport, M. T., Sokol, E. R., Comiter, C. V., Elliott, C. S. 2018; 24 (4): 292–94

  Abstract

  Cystoceles may cause urethral obstruction by altering the vesicourethral angle. Restoration of normal anatomy after pelvic organ prolapse (POP) repair can relieve this obstruction but may unmask stress urinary incontinence (SUI). The association between the severity of cystocele and developing de novo SUI after prolapse repair, however, is poorly understood. We hypothesized that, in women undergoing prolapse repair, increasing degrees of bladder prolapse would be associated with increasing rates of postoperative de novo SUI.We performed a secondary analysis of the Colpopexy and Urinary Reduction Efforts (CARE) trial data. Using the control arm (women undergoing prolapse repair without a prophylactic SUI procedure), we identified de novo SUI using a composite definition based on original trial criteria. We performed logistic regression to evaluate the relationship between the degree of cystocele and the development of new SUI.Of the 164 women who underwent abdominal sacrocolpopexy alone, 54% developed de novo postoperative SUI. Stratifying by the degree of anterior prolapse (point Ba), we found a linear increase in the rate of SUI with worsening preoperative cystocele. The incidence of de novo SUI based on the POP Quantification stage of anterior prolapse was 41.3%, 52.5%, and 66.1%, for stage 2, early stage 3, and advanced stage 3 or stage 4, respectively. Point Ba was found to be significantly associated with de novo SUI on both univariate (odds ratio = 1.17, P = 0.015) and multivariate analysis (odds ratio = 1.16, P = 0.04).The incidence of de novo SUI after prolapse repair directly correlates to the degree of cystocele on preoperative examination. This simple yet novel relationship should further guide discussions about potential postoperative incontinence.

  View details for PubMedID 28953571

• Untitled Reply MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY Sokol, E. R. 2018; 25 (2): 243–44

  View details for PubMedID 29342027

• In Reply. Menopause (New York, N.Y.) Sokol, E. R. 2017

  View details for DOI 10.1097/GME.0000000000001035

  View details for PubMedID 29210880

• Inappropriate oophorectomy at time of benign premenopausal hysterectomy. Menopause (New York, N.Y.) Mahal, A. S., Rhoads, K. F., Elliott, C. S., Sokol, E. R. 2017

  Abstract

  We assessed rates of oophorectomy during benign hysterectomy around the release of the American College of Obstetricians and Gynecologists 2008 practice bulletin on prophylactic oophorectomy, and evaluated predictors of inappropriate premenopausal oophorectomy.A cross-sectional administrative database analysis was performed utilizing the California Office of Statewide Health Planning Development Patient Discharge Database for years 2005 to 2011. After identifying all premenopausal women undergoing hysterectomy for benign conditions, International Classification of Diseases (ICD)-9 diagnosis codes were reviewed to create a master list of indications for oophorectomy. We defined appropriate oophorectomy as cases with concomitant coding for ovarian cyst, breast cancer susceptibility gene carrier status, and other diagnoses. Using patient demographics and hospital characteristics to predict inappropriate oophorectomy, a logistic regression model was created.We identified 57,776 benign premenopausal hysterectomies with oophorectomies during the period studied. Of the premenopausal oophorectomies, 37.7% (21,783) were deemed "inappropriate" with no documented reason for removal. The total number of premenopausal inpatient hysterectomies with oophorectomy decreased yearly (12,227/y in 2005 to 5,930/y in 2011). However, the percentage of inappropriate oophorectomies remained stable. In multivariate analysis, Hispanic and African American ethnicity/race associated with increased odds of inappropriate oophorectomy (P < 0.001). Urban and at low Medi-Cal utilization hospitals showed increased odds of inappropriate oophorectomy.In premenopausal women undergoing benign hysterectomy, over one-third undergo oophorectomy without an appropriate indication documented. The rate of inappropriate oophorectomy in California has not changed since the 2008 American College of Obstetricians and Gynecologists guidelines. Whereas the absolute number of inpatient hysterectomies for benign indications has decreased, our work suggests persistent utilization of oophorectomy in premenopausal women, despite well-documented long-term adverse health implications.

  View details for DOI 10.1097/GME.0000000000000875

  View details for PubMedID 28486247

• Use of a novel fractional CO2 laser for the treatment of genitourinary syndrome of menopause: 1-year outcomes. Menopause (New York, N.Y.) Sokol, E. R., Karram, M. M. 2017

  Abstract

  To assess safety and efficacy of a fractional CO2 laser therapy for the treatment of genitourinary syndrome of menopause (GSM) with follow-up to 1 year posttreatment.Women presenting with GSM and meeting inclusion criterion were enrolled. Visual Analog Scales were used to grade vaginal pain, burning, itching, dryness, dyspareunia, and dysuria. Dilators were used to rate vaginal elasticity at baseline and at each follow-up visit. Before each treatment and at follow-up, Vaginal Health Index scoring and Female Sexual Function Index questionnaires were completed. Women received three vaginal laser treatments spaced 6 weeks apart. Participant satisfaction was measured on 5-point Likert scales (1 = very dissatisfied, 5 = very satisfied).Of 30 women (mean age 58.6 ± 8.8 years), three were lost to follow-up at 3 months and six at 1 year. None were discontinued or withdrew due to an adverse event. Average improvement in Visual Analog Scale scores for all symptom categories was statistically significant at 3 months and remained so through 1 year, except dysuria. Differences between data at 3 months and 1 year were not statistically significant, indicating persistence of positive outcomes. Average overall improvement in pain was 1.9 (±3.4), burning 1.9 (±3.1), itching 1.4 (±1.9), dryness 5.9 (±2.8), dyspareunia 4.9 (±3.3), and dysuria 0.9 (±3.1). Improvement in average Vaginal Health Index and Female Sexual Function Index scores was also statistically significant (P < 0.0001). Of 19 women undergoing dilator examination at 1 year, 18 (94.8%) were comfortable with the same or larger dilator size. Twenty-two of 24 women (92%) were satisfied or extremely satisfied with the treatment at 1 year.Based on study data up to 1 year, the fractional CO2 laser may be an effective and safe treatment for women suffering from symptoms of GSM, although additional studies with larger populations and placebo control is needed to confirm these results.

  View details for DOI 10.1097/GME.0000000000000839

  View details for PubMedID 28169913

• Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY Gutman, R. E., Rardin, C. R., Sokol, E. R., Matthews, C., Park, A. J., Iglesia, C. B., Geoffrion, R., Sokol, A. I., Karram, M., Cundiff, G. W., Blomquist, J. L., Barber, M. D. 2017; 216 (1)

  Abstract

  There is growing interest in uterine conservation at the time of surgery for uterovaginal prolapse, but limited data compare different types of hysteropexy.We sought to compare 1-year efficacy and safety of laparoscopic sacral hysteropexy and vaginal mesh hysteropexy.This multicenter, prospective parallel cohort study compared laparoscopic sacral hysteropexy to vaginal mesh hysteropexy at 8 institutions. We included women ages 35-80 years who desired uterine conservation, were done with childbearing, and were undergoing 1 of the above procedures for stage 2-4 symptomatic anterior/apical uterovaginal prolapse (anterior descent at or beyond the hymen [Aa or Ba ≥ 0] and apical descent at or below the midvagina [C ≥ -TVL/2]). We excluded women with cervical elongation, prior mesh prolapse repair, cervical dysplasia, chronic pelvic pain, uterine abnormalities, and abnormal bleeding. Cure was defined as no prolapse beyond the hymen and cervix above midvagina (anatomic), no vaginal bulge sensation (symptomatic), and no reoperations. Pelvic Organ Prolapse Quantification examination and validated questionnaires were collected at baseline and 12 months including the Pelvic Floor Distress Inventory Short Form, Female Sexual Function Index, and Patient Global Impression of Improvement. In all, 72 subjects/group were required to detect 94% vs 75% cure (80% power, 15% dropout). Intention-to-treat analysis was used with logistic regression adjusting for baseline differences.We performed 74 laparoscopic sacral hysteropexy and 76 vaginal mesh hysteropexy procedures from July 2011 through May 2014. Laparoscopic patients were younger (P < .001), had lower parity (P = .006), were more likely premenopausal (P = .008), and had more severe prolapse (P = .02). Laparoscopic procedure (174 vs 64 minutes, P < .0001) and total operating time (239 vs 112 minutes, P < .0001) were longer. There were no differences in blood loss, complications, and hospital stay. One-year outcomes for the available 83% laparoscopic and 80% vaginal hysteropexy patients revealed no differences in anatomic (77% vs 80%; adjusted odds ratio, 0.48; P = .20), symptomatic (90% vs 95%; adjusted odds ratio, 0.40; P = .22), or composite (72% vs 74%; adjusted odds ratio, 0.58; P = .27) cure. Mesh exposures occurred in 2.7% laparoscopic vs 6.6% vaginal hysteropexy (P = .44). A total of 95% of each group were very much better or much better. Pelvic floor symptom and sexual function scores improved for both groups with no difference between groups.Laparoscopic sacral hysteropexy and vaginal mesh hysteropexy had similar 1-year cure rates and high satisfaction.

  View details for DOI 10.1016/j.ajog.2016.08.035

  View details for Web of Science ID 000396381100006

• An assessment of the safety and efficacy of a fractional CO2 laser system for the treatment of vulvovaginal atrophy MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY Sokol, E. R., Karram, M. M. 2016; 23 (10): 1102-1107

  Abstract

  The aim of the study was to assess the safety and efficacy of a novel fractional CO2 laser for the treatment of genitourinary syndrome of menopause (GSM).Women presenting with GSM and meeting study criteria were enrolled. Examinations at baseline and follow-up (3 mo after final treatment) evaluated dilator tolerance and vaginal pH. Visual analog scales were used to assess pain, vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria; Vaginal Health Index scores were completed before each treatment and at follow-up; Female Sexual Function Index and Short Form 12 questionnaires were also completed. Participant satisfaction was measured on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Women received three laser treatments, 6 weeks apart.Thirty women participated (mean age 58.6 ± 8.8 y). None withdrew or were discontinued due to an adverse event; three were lost to follow-up. Average improvement in visual analog scale scoring was 1.7 ± 3.2 for pain, 1.4 ± 2.9 for burning, 1.4 ± 1.9 for itching, 6.1 ± 2.7 for dryness, 5.1 ± 3.0 for dyspareunia, and 1.0 ± 2.4 for dysuria; improvement in average Vaginal Health Index and Female Sexual Function Index scores were statistically significant (P < 0.001). Twenty-five of 30 participants (83%) showed increase in comfortable dilator size at 3-month follow up. Before the second and third treatments, 86.6% (26 of 30) of women reported they were better or much better than at the previous treatment; 26 of 27 women (96%) were reportedly satisfied or extremely satisfied at follow-up.In this sample, the data suggest that the fractional CO2 laser is effective and safe for treatment of the symptoms associated with GSM.

  View details for DOI 10.1097/GME.0000000000000700

  View details for PubMedID 27404032

• Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study. American journal of obstetrics and gynecology Gutman, R. E., Rardin, C. R., Sokol, E. R., Matthews, C., Park, A. J., Iglesia, C. B., Geoffrion, R., Sokol, A. I., Karram, M., Cundiff, G. W., Blomquist, J. L., Barber, M. D. 2016

  Abstract

  There is growing interest in uterine conservation at the time of surgery for uterovaginal prolapse, but limited data compare different types of hysteropexy.We sought to compare 1-year efficacy and safety of laparoscopic sacral hysteropexy and vaginal mesh hysteropexy.This multicenter, prospective parallel cohort study compared laparoscopic sacral hysteropexy to vaginal mesh hysteropexy at 8 institutions. We included women ages 35-80 years who desired uterine conservation, were done with childbearing, and were undergoing 1 of the above procedures for stage 2-4 symptomatic anterior/apical uterovaginal prolapse (anterior descent at or beyond the hymen [Aa or Ba ≥ 0] and apical descent at or below the midvagina [C ≥ -TVL/2]). We excluded women with cervical elongation, prior mesh prolapse repair, cervical dysplasia, chronic pelvic pain, uterine abnormalities, and abnormal bleeding. Cure was defined as no prolapse beyond the hymen and cervix above midvagina (anatomic), no vaginal bulge sensation (symptomatic), and no reoperations. Pelvic Organ Prolapse Quantification examination and validated questionnaires were collected at baseline and 12 months including the Pelvic Floor Distress Inventory Short Form, Female Sexual Function Index, and Patient Global Impression of Improvement. In all, 72 subjects/group were required to detect 94% vs 75% cure (80% power, 15% dropout). Intention-to-treat analysis was used with logistic regression adjusting for baseline differences.We performed 74 laparoscopic sacral hysteropexy and 76 vaginal mesh hysteropexy procedures from July 2011 through May 2014. Laparoscopic patients were younger (P < .001), had lower parity (P = .006), were more likely premenopausal (P = .008), and had more severe prolapse (P = .02). Laparoscopic procedure (174 vs 64 minutes, P < .0001) and total operating time (239 vs 112 minutes, P < .0001) were longer. There were no differences in blood loss, complications, and hospital stay. One-year outcomes for the available 83% laparoscopic and 80% vaginal hysteropexy patients revealed no differences in anatomic (77% vs 80%; adjusted odds ratio, 0.48; P = .20), symptomatic (90% vs 95%; adjusted odds ratio, 0.40; P = .22), or composite (72% vs 74%; adjusted odds ratio, 0.58; P = .27) cure. Mesh exposures occurred in 2.7% laparoscopic vs 6.6% vaginal hysteropexy (P = .44). A total of 95% of each group were very much better or much better. Pelvic floor symptom and sexual function scores improved for both groups with no difference between groups.Laparoscopic sacral hysteropexy and vaginal mesh hysteropexy had similar 1-year cure rates and high satisfaction.

  View details for DOI 10.1016/j.ajog.2016.08.035

  View details for PubMedID 27596620

• Impact of the 2014 Food and Drug Administration Warnings Against Power Morcellation JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY Lum, D. A., Sokol, E. R., Berek, J. S., Schulkin, J., Chen, L., McElwain, C., Wright, J. D. 2016; 23 (4): 548-556

  Abstract

  To determine whether members of the AAGL Advancing Minimally Invasive Gynecologic Surgery Worldwide (AAGL) and members of the American College of Obstetricians and Gynecologists Collaborative Ambulatory Research Network (ACOG CARN) have changed their clinical practice based on the 2014 Food and Drug Administration (FDA) warnings against power morcellation.A survey study.Participants were invited to complete this online survey (Canadian Task Force classification II-2).AAGL and ACOG CARN members.An online anonymous survey with 24 questions regarding demographics and changes to clinical practice during minimally invasive myomectomies and hysterectomies based on the 2014 FDA warnings against power morcellation.A total of 615 AAGL members and 54 ACOG CARN members responded (response rates of 8.2% and 60%, respectively). Before the FDA warnings, 85.8% and 86.9%, respectively, were using power morcellation during myomectomies and hysterectomies. After the FDA warnings, 71.1% and 75.8% of respondents reported stopping the use of power morcellation during myomectomies and hysterectomies. The most common reasons cited for discontinuing the use of power morcellation or using it less often were hospital mandate (45.6%), the concern for legal consequences (16.1%), and the April 2014 FDA warning (13.9%). Nearly half of the respondents (45.6%) reported an increase in their rate of laparotomy. Most (80.3%) believed that the 2014 FDA warnings have not led to an improvement in patient outcomes and have led to harming patients (55.1%).AAGL and ACOG CARN respondents reported decreased use of power morcellation during minimally invasive gynecologic surgery after the 2014 FDA warnings, the most common reason cited being hospital mandate. Rates of laparotomy have increased. Most members surveyed believe that the FDA warnings have not improved patient outcomes.

  View details for DOI 10.1016/j.jmig.2016.01.019

  View details for PubMedID 26827905

• Rates of inappropriate oophorectomy at the time of benign hysterectomy Mahal, A. S., Elliott, C., Sokol, E. R. MOSBY-ELSEVIER. 2016: S465–S466

  View details for DOI 10.1016/j.ajog.2016.01.028

  View details for Web of Science ID 000372080500020

• Abdominal sacral colpopexy versus sacrospinous ligament fixation: a cost-effectiveness analysis. International urogynecology journal Ohno, M. S., Richardson, M. L., Sokol, E. R. 2016; 27 (2): 233-237

  Abstract

  For the surgical correction of apical prolapse the abdominal approach is associated with better outcomes; however, it is more expensive than the transvaginal approach. This cost-effectiveness analysis compares abdominal sacral colpopexy (ASC) with sacrospinous ligament fixation (SSLF) to determine if the improved outcomes of ASC justify the increased expense.A decision-analytic model was created comparing ASC with SSLF using data-modeling software, TreeAge Pro (2013), which included the following outcomes: post-operative stress urinary incontinence (SUI) with possible mid-urethral sling (MUS) placement, prolapse recurrence with possible re-operation, and post-operative dyspareunia. Cost-effectiveness was defined as an incremental cost-effectiveness ratio (ICER) of less than $50,000 per quality-associated life year (QALY). Base-case, threshold, and one-way sensitivity analyses were performed.At the baseline, ASC is more expensive than SSLF ($13,988 vs $11,950), but is more effective (QALY 1.53 vs 1.45) and is cost-effective (ICER $24,574/QALY) at 2 years. ASC was not cost-effective if the following four thresholds were met: the rate of post-operative SUI was above 36 % after ASC or below 28 % after SSLF; the rate of MUS placement for post-operative SUI was above 60 % after ASC or below 13 % after SSLF; the rate of recurrent prolapse was above 15 % after ASC or below 4 % after SSLF; the rate of post-operative dyspareunia was above 59 % after ASC or below 19 % after SSLF.Abdominal sacral colpopexy can be cost-effective compared with sacrospinous ligament fixation; however, as the post-operative outcomes of SSLF improve, SSLF can be considered a cost-effective alternative.

  View details for DOI 10.1007/s00192-015-2819-1

  View details for PubMedID 26282093

• DOES THE DEGREE OF CYSTOCELE PREDICT DE-NOVO STRESS URINARY INCONTINENCE AFTER PROLAPSE REPAIR? FURTHER ANALYSIS OF THE CARE TRIAL Davenport, M., Sokol, E., Elliott, C. WILEY-BLACKWELL. 2016: S96

  View details for Web of Science ID 000369726700236

• Management of fecal incontinence - focus on a vaginal insert for bowel control. Medical devices (Auckland, N.Z.) Sokol, E. R. 2016; 9: 85-91

  Abstract

  Fecal incontinence, also referred to as accidental bowel leakage, is a debilitating condition that impacts quality of life in a significant number of women. Current treatments for fecal incontinence include behavioral modification, biofeedback, drug therapy, and invasive surgical procedures. However, these treatments have suboptimal efficacy due to patient adherence, variability of presentation across patients, cost, and additional health risks. A vaginal bowel control system (Eclipse™ System) was developed to offer a low-risk, effective, and patient-managed approach to treating accidental bowel leakage. The vaginal bowel control system consists of a vaginal insert and user-controlled, pressure-regulated pump. Once inflated, the balloon of the vaginal insert is directed posteriorly to occlude the rectum, allowing the woman to immediately regain control of bowel function. This article will introduce the design evolution and feasibility studies of the Eclipse System. In addition, this review will discuss the results from a recent clinical trial that demonstrated the safety and efficacy of the vaginal bowel control system in managing fecal incontinence and other symptoms of bowel dysfunction.

  View details for DOI 10.2147/MDER.S86483

  View details for PubMedID 27274318

• Use of a novel fractional CO2 laser for the treatment of genitourinary syndrome of menopause Sokol, E. R., Karram, M. LIPPINCOTT WILLIAMS & WILKINS. 2015: 1388–89

  View details for Web of Science ID 000369888500118

• Impact of the 2014 FDA Warnings Against Laparoscopic Power Morcellation. Journal of minimally invasive gynecology Lum, D., Berek, J. S., Sheikhi, F., Sokol, E. R. 2015; 22 (6S): S77-?

  View details for DOI 10.1016/j.jmig.2015.08.207

  View details for PubMedID 27679337

• Might Pelvic Surgeons Be Unaware of Their Surgical Failures? Patient Reporting and Perceptions After Failed Incontinence or Pelvic Organ Prolapse Surgery. Female pelvic medicine and reconstructive surgery Elliott, C. S., Sokol, E. R. 2015; 21 (5): 298-300

  Abstract

  : Prior studies suggest that pelvic organ prolapse (POP) and stress urinary incontinence (SUI) may recur following surgery in 20% or more of patients. Despite these numbers, we have anecdotally found that some surgeons performing pelvic floor reconstruction feel their success rates exceed these figures. Based on our experience, we hypothesized that significant numbers of patients with recurrent POP or SUI following prior surgery do not return or notify their original surgeon of their recurrence. We also aimed to identify reasons why the patient was seeking care elsewhere.We investigated patients presenting to a tertiary referral center urogynecologic practice with recurrence after prior POP or SUI surgery over a 2-year period. Data were collected using an institutional review board-approved 15-item questionnaire and after 2 years were analyzed.We found that 16 (31%) of 51 patients did not notify their primary surgeon of surgical failure. Of these patients, roughly half (9/16) did not return because of moving to a different area of the country, changing their insurance, or their prior physician retiring. Despite the surgical failures, of all patients presenting to our clinic, very few stated they had a poor relationship with their prior surgeon (6%); however, a large majority (63%) did not think that their primary surgeon could fix their problem.Roughly one third of patients who suffer from recurrence after POP or SUI surgery do not notify their original surgeon. This may artificially inflate a clinician's perceived success rate of pelvic floor repair.

  View details for DOI 10.1097/SPV.0000000000000187

  View details for PubMedID 26197042

• ARE PELVIC SURGEONS AWARE OF THEIR SURGICAL FAILURES? - PATIENT PERCEPTIONS AFTER FAILED INCONTINENCE OR PELVIC ORGAN PROLAPSE SURGERY Elliott, C., Sokol, E. WILEY-BLACKWELL. 2015: S46–S47

  View details for Web of Science ID 000349293400105

• A cost-effectiveness analysis of conservative versus surgical management for the initial treatment of stress urinary incontinence 40th Annual Scientific Meeting of the Society-of-Gynecologic-Surgeons Richardson, M. L., Sokol, E. R. MOSBY-ELSEVIER. 2014

  Abstract

  We sought to determine whether conservative or surgical therapy is more cost effective for the initial treatment of stress urinary incontinence (SUI).We created a decision tree model to compare costs and cost effectiveness of 3 strategies for the initial treatment of SUI: (1) continence pessary, (2) pelvic floor muscle therapy (PFMT), and (3) midurethral sling (MUS). We identified probabilities of SUI after 12 months of use of a pessary, PFMT, or MUS using published data. Parameter estimates included Health Utility Indices of no incontinence (.93) and persistent incontinence (0.7) after treatment. Morbidities associated with MUS included mesh erosion, retention, de novo urge incontinence, and recurrent SUI. Cost data were derived from Medicare in 2012 US dollars. One- and 2-way sensitivity analysis was used to examine the effect of varying rates of pursuing surgery if conservative management failed and rates of SUI cure with pessaries and PFMT. The primary outcome was an incremental cost-effectiveness ratio threshold <$50,000.Compared to PFMT, initial treatment of SUI with MUS was the more cost-effective strategy with an incremental cost-effectiveness ratio of $32,132/quality-adjusted life year. Initial treatment with PFMT was also acceptable as long as subjective cure was >35%. In 3-way sensitivity analysis, subjective cure would need to be >40.5% for PFMT and 43.5% for a continence pessary for the MUS scenario to not be the preferred strategy.At 1 year, MUS is more cost effective than a continence pessary or PFMT for the initial treatment for SUI.

  View details for DOI 10.1016/j.ajog.2014.07.006

  View details for Web of Science ID 000344470500045

• A cost-effectiveness analysis of conservative versus surgical management for the initial treatment of stress urinary incontinence. American journal of obstetrics and gynecology Richardson, M. L., Sokol, E. R. 2014; 211 (5): 565 e1-6

  Abstract

  We sought to determine whether conservative or surgical therapy is more cost effective for the initial treatment of stress urinary incontinence (SUI).We created a decision tree model to compare costs and cost effectiveness of 3 strategies for the initial treatment of SUI: (1) continence pessary, (2) pelvic floor muscle therapy (PFMT), and (3) midurethral sling (MUS). We identified probabilities of SUI after 12 months of use of a pessary, PFMT, or MUS using published data. Parameter estimates included Health Utility Indices of no incontinence (.93) and persistent incontinence (0.7) after treatment. Morbidities associated with MUS included mesh erosion, retention, de novo urge incontinence, and recurrent SUI. Cost data were derived from Medicare in 2012 US dollars. One- and 2-way sensitivity analysis was used to examine the effect of varying rates of pursuing surgery if conservative management failed and rates of SUI cure with pessaries and PFMT. The primary outcome was an incremental cost-effectiveness ratio threshold <$50,000.Compared to PFMT, initial treatment of SUI with MUS was the more cost-effective strategy with an incremental cost-effectiveness ratio of $32,132/quality-adjusted life year. Initial treatment with PFMT was also acceptable as long as subjective cure was >35%. In 3-way sensitivity analysis, subjective cure would need to be >40.5% for PFMT and 43.5% for a continence pessary for the MUS scenario to not be the preferred strategy.At 1 year, MUS is more cost effective than a continence pessary or PFMT for the initial treatment for SUI.

  View details for DOI 10.1016/j.ajog.2014.07.006

  View details for PubMedID 25019485

• Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: a randomized, prospective, multicenter north american study. journal of urology Sokol, E. R., Karram, M. M., Dmochowski, R. 2014; 192 (3): 843-849

  Abstract

  Bulkamid® is a new polyacrylamide hydrogel bulking agent for stress urinary incontinence that is injected in the urethral submucosa using a specifically designed device. We evaluated the safety and efficacy of Bulkamid vs Contigen® collagen gel for stress urinary incontinence or stress predominant mixed urinary incontinence.This was a single-blind, randomized, prospective, 33-center, 2-arm parallel study of hydrogel vs collagen gel with followup to 1 year. At baseline patients underwent physical examination and bladder testing, and completed quality of life questionnaires and bladder diaries. After randomization patients could receive up to 3 injections at 1-month intervals. Patients were assessed 3, 6, 9 and 12 months after bulking. They completed bladder diaries and quality of life questionnaires, and pad weight was tested. At the last visit Valsalva leak point pressure was measured. Subjective and objective incontinence outcomes and adverse events were compared.Of the 345 women 229 were randomized to hydrogel and 116 were randomized to collagen gel. At 12 months a 50% or greater decrease in leakage and incontinence episodes was seen in 53.2% and 55.4% of patients who received hydrogel and collagen gel, respectively. At 12 months 47.2% of patients with hydrogel and 50% with collagen gel reported zero stress incontinence episodes, and 77.1% and 70%, respectively, considered themselves cured or improved. Major adverse events were rare in each group.Bulkamid is not inferior to Contigen. It has a favorable, persistent effect on stress urinary incontinence with a low risk of serious adverse events. Bulkamid is a new, simple, office based bulking system that shows promise as a treatment in women with stress urinary incontinence, particularly since Contigen is no longer commercially available.

  View details for DOI 10.1016/j.juro.2014.03.109

  View details for PubMedID 24704117

• IMPROVED QUALITY OF LIFE AND SEXUAL FUNCTION FOLLOWING BULKAMID TREATMENT: PATIENT SUBJECTIVE OUTCOME DATA FROM A SINGLE-MASKED, RANDOMIZED, MULTI-CENTER, COMPARATIVE STUDY Sokol, E. R., Karram, M., Dmochowski, R. SPRINGER LONDON LTD. 2014: S128–S129

  View details for Web of Science ID 000339342800122

• ABDOMINAL SACRAL COLPOPEXY VERSUS SACROSPINOUS LIGAMENT FIXATION: A COST-EFFECTIVENESS ANALYSIS Ohno, M. S., Richardson, M. L., Sokol, E. R. SPRINGER LONDON LTD. 2014: S33–S34

  View details for Web of Science ID 000339342800030

• Improving the accuracy of prolapse and incontinence procedure epidemiology by utilizing both inpatient and outpatient data INTERNATIONAL UROGYNECOLOGY JOURNAL Elliott, C. S., Rhoads, K. F., Comiter, C. V., Chen, B., Sokol, E. R. 2013; 24 (11): 1939-1946

  Abstract

  INTRODUCTION AND HYPOTHESIS: The epidemiologic description of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) procedures is documented in several large studies using national database cohorts. These studies, however, may underestimate the number of procedures performed because they only capture procedures performed in either the inpatient or outpatient settings alone. We present a complete annual description of all inpatient and outpatient surgeries for POP and SUI in California. METHODS: We reviewed a record of all inpatient and outpatient POP and SUI surgeries performed in California in 2008 using data from the Office of Statewide Health Planning (OSHPD). RESULTS: In 2008, 20,004 and 20,330 women in California underwent POP and SUI procedures, respectively. Of these, 3,134 (15.6 %) and 9,016 (44.3 %) were performed in an outpatient setting. The age-adjusted rates of POP and SUI were 1.20 and 1.20 per 1,000 US females, respectively. This correlates to 186,000 POP and 186,000 SUI procedures per year nationally. Vaginal apical suspensions were more common in those undergoing surgery as an inpatient (45.1 vs 19.4 %). The use of mesh to augment prolapse repairs was similar (22.3 % inpatient vs 19.3 % outpatient). SUI procedures performed in the outpatient setting were more likely to be performed as stand-alone procedures (82.9 vs 18.8 %, respectively). CONCLUSIONS: In California, 16 % of POP and 44 % of SUI procedures were performed in an outpatient surgical setting in 2008. Epidemiologic studies of POP and SUI should account for the fact that a substantial number of repairs are performed in the outpatient setting in order to achieve accuracy.

  View details for DOI 10.1007/s00192-013-2113-z

  View details for PubMedID 23640007

• To sling or not to sling at time of abdominal sacrocolpopexy: a cost-effectiveness analysis. journal of urology Richardson, M. L., Elliott, C. S., Shaw, J. G., Comiter, C. V., Chen, B., Sokol, E. R. 2013; 190 (4): 1306-1312

  Abstract

  OBJECTIVES: To compare the cost-effectiveness of three strategies for use of a mid-urethral sling (MUS) to prevent occult stress urinary incontinence (SUI) in those undergoing abdominal sacrocolpopexy (ASC). METHODS: Using decision-analysis modeling, we compared cost-effectiveness over a 1 year post-operative time period of three treatment approaches: 1) ASC alone with deferred option for MUS; 2) ASC with universal concomitant MUS; and 3) preoperative urodynamic study (UDS) for selective MUS. Using published data, we modeled probabilities of SUI after ASC with or without MUS, the predictive value of UDS to detect occult SUI, and the likelihood of complications after MUS. Costs were derived from Medicare 2010 reimbursement rates. The main outcome modeled was incremental cost effectiveness ratio (ICER) per quality-adjusted life years (QALY) gained. In addition to base-case analysis, one-way sensitivity analyses were performed. RESULTS: In our model, universally performing MUS at the time of ASC was the most cost-effective approach, with an incremental cost per QALY gained of $2867 when compared to performing ASC alone. Preoperative UDS was more costly and less effective than universally performing intraoperative MUS. The cost-effectiveness of ASC + MUS was robust to sensitivity analysis, with a cost-effectiveness ratio consistently below $20,000 per QALY. CONCLUSIONS: Universal concomitant MUS is the most cost-effective prophylaxis strategy for occult SUI in women undergoing ASC. The use of pre-operative UDS to guide MUS placement at the time of ASC is not cost-effective.

  View details for DOI 10.1016/j.juro.2013.03.046

  View details for PubMedID 23524201

• Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial. Obstetrics and gynecology Gutman, R. E., Nosti, P. A., Sokol, A. I., Sokol, E. R., Peterson, J. L., Wang, H., Iglesia, C. B. 2013; 122 (4): 770-777

  Abstract

  To present the 3-year outcomes of a double-blind, multicenter, randomized trial comparing vaginal prolapse repair with and without mesh.This was a planned final analysis of women with Pelvic Organ Prolapse Quantification (POP-Q) stage 2-4 prolapse randomized to traditional vaginal prolapse surgery without mesh and vaginal colpopexy repair with mesh. We evaluated anatomic, symptomatic, and combined cure rates for those with at least 3-year validated quality-of-life questionnaires and 2- or 3-year postoperative blinded POP-Q examination. Participants undergoing reoperation for recurrent prolapse were removed for anatomic and subjective outcomes analysis and considered failures for combined outcomes analysis.Sixty-five women were enrolled (33 mesh, 32 no mesh) before the study was prematurely halted as a result of a 15.6% mesh exposure rate. At 3 years, 51 of 65 (78%) had quality-of-life questionnaires (25 mesh, 26 no mesh) and 41 (63%) had examinations. Three participants died, three required reoperation for recurrent prolapse (all in mesh group), and eight were lost to follow-up. No differences were observed between groups at 3 years for prolapse stage or individual prolapse points. Stage improved for each group (90% and 86%) from baseline to 3 years (P<.01). Symptomatic improvement was observed with no differences in scores between groups. Cure rates did not differ between groups using a variety of definitions, and anatomic cure was lowest for the anterior compartment.There was no difference in 3-year cure rates when comparing patients undergoing traditional vaginal prolapse surgery without mesh with those undergoing vaginal colpopexy repair with mesh.Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540.: I.

  View details for DOI 10.1097/AOG.0b013e3182a49dac

  View details for PubMedID 24084533

• THE EPIDEMIOLOGY OF INPATIENT AND OUTPATIENT PROLAPSE AND INCONTINENCE PROCEDURES IN THE STATE OF CALIFORNIA Elliott, C., Rhoads, K., Comiter, C., Chen, B., Sokol, E. WILEY-BLACKWELL. 2013: 193

  View details for Web of Science ID 000315223200198

• The Predictive Value of a Cystocele for Concomitant Vaginal Apical Prolapse JOURNAL OF UROLOGY Elliott, C. S., Yeh, J., Comiter, C. V., Chen, B., Sokol, E. R. 2013; 189 (1): 200-203

  Abstract

  Recent studies showing a correlation between descent of the anterior and apical vaginal compartments suggest that cystoceles may recur if associated apical prolapse is not corrected. However, to date the anatomical relationship of apical prolapse with respect to cystocele has been incompletely reported. We present the predictive value of a cystocele for clinically significant vaginal apical prolapse.We retrospectively reviewed the records of all new patient visits to a urogynecology clinic in a 30-month period. Women with a point Ba value of -1 or greater (stage 2 cystocele and above) were included in analysis. Predictive values of clinically significant apical prolapse, defined as point C -3 or greater, were calculated and stratified by cystocele stage.A total of 385 women were included in study. Point Ba was the leading edge of prolapse in 83.9% of cases. The position of Ba strongly correlated with that of the vaginal apex (Spearman ρ = 0.769, p <0.001). Overall 59.7% of patients had a point C of -3 or greater. The finding of clinically significant apical prolapse increased significantly with increasing Ba values. Of patients with stage 2, 3 and 4 cystocele point C was -3 or greater in 42%, 85% and 100%, respectively.The finding of stage 2 or greater cystocele is highly suggestive of clinically significant apical vaginal descent to -3 or greater. Furthermore, as cystocele stage increases, the predictive value of apical prolapse also increases. Surgeons contemplating cystocele repair should have high suspicion for vaginal apical prolapse and consider concomitant repair.

  View details for DOI 10.1016/j.juro.2012.08.177

  View details for PubMedID 23174246

• Posterior Compartment Prolapse: A Urogynecology Perspective UROLOGIC CLINICS OF NORTH AMERICA Richardson, M. L., Elliot, C. S., Sokol, E. R. 2012; 39 (3): 361-?

  Abstract

  Posterior compartment prolapse is often caused by a defect in the rectovaginal septum, also known as Denonvillier's fascia. Patients with symptomatic posterior compartment prolapse can present with bulge symptoms as well as defecatory dysfunction, including constipation, tenesmus, splinting, and fecal incontinence. The diagnosis can successfully be made on clinical examination. Treatment of posterior prolapse includes pessaries and surgery. Both traditional colporrhaphy and site-specific defect repair have excellent success rates. Complications from surgery can include sexual dysfunction, de novo dyspareunia, and defecatory dysfunction. Compared with native tissue repair, biological and synthetic grafting has not improved overall anatomic and subjective outcomes.

  View details for DOI 10.1016/j.ucl.2012.06.005

  View details for PubMedID 22877719

• Robot-Assisted Versus Open Sacrocolpopexy: A Cost-Minimization Analysis JOURNAL OF UROLOGY Elliott, C. S., Hsieh, M. H., Sokol, E. R., Comiter, C. V., Payne, C. K., Chen, B. 2012; 187 (2): 638-643

  Abstract

  Abdominal sacrocolpopexy is considered a standard of care operation for apical vaginal vault prolapse repair. Using outcomes at our center we evaluated whether the robotic approach to sacrocolpopexy is as cost-effective as the open approach.After obtaining institutional review board approval we performed cost-minimization analysis in a retrospective cohort of patients who underwent sacrocolpopexy at our institution between 2006 and 2010. Threshold values, that is model variable values at which the most cost effective approach crosses over to an alternative approach, were determined by testing model variables over realistic ranges using sensitivity analysis. Hospital billing data were also evaluated to confirm our findings.Operative time was similar for robotic and open surgery (226 vs 221 minutes) but postoperative length of stay differed significantly (1.0 vs 3.3 days, p <0.001). Base case analysis revealed an overall 10% cost savings for robot-assisted vs open sacrocolpopexy ($10,178 vs $11,307). Tornado analysis suggested that the number of institutional robotic cases done annually, length of stay and cost per hospitalization day in the postoperative period were the largest drivers of cost. Analysis of our hospital billing data showed a similar trend with robotic surgery costing 4.2% less than open surgery.A robot-assisted approach to sacrocolpopexy can be equally or less costly than an open approach. This depends on a sufficient institutional robotic case volume and a shorter postoperative stay for patients who undergo the robot-assisted procedure.

  View details for DOI 10.1016/j.juro.2011.09.160

  View details for PubMedID 22177180

• THE ANATOMIC RELATIONSHIP BETWEEN THE ANTERIOR VAGINAL WALL AND THE VAGINAL APEX IN WOMEN WITH STAGE 2 OR GREATER CYSTOCELE Elliott, C., Comiter, C., Chen, B., Sokol, E. WILEY-BLACKWELL. 2012: 218–19

  View details for Web of Science ID 000300502400020

• One-year objective and functional outcomes of a randomized clinical trial of vaginal mesh for prolapse 31st Annual Scientific Meeting of the American-Urogynecologic-Society Sokol, A. I., Iglesia, C. B., Kudish, B. I., Gutman, R. E., Shveiky, D., Bercik, R., Sokol, E. R. MOSBY-ELSEVIER. 2012

  Abstract

  The purpose of this study was to show 12-month outcomes of a randomized trial that compared vaginal prolapse repair with and without mesh.Women with stage ≥2 prolapse were assigned randomly to vaginal repair with or without mesh. The primary outcome was prolapse stage ≤1 at 12 months. Secondary outcomes included quality of life and complications.All 65 evaluable participants were followed for 12 months after trial stoppage for mesh exposures. Thirty-two women had mesh repair; 33 women had traditional repair. At 12 months, both groups had improvement of pelvic organ prolapse-quantification test points to similar recurrence rates. The quality of life improved and did not differ between groups: 96.2% mesh vs 90.9% no-mesh subjects reported a cure of bulge symptoms; 15.6% had mesh exposures, and reoperation rates were higher with mesh.Objective and subjective improvement is seen after vaginal prolapse repair with or without mesh. However, mesh resulted in a higher reoperation rate and did not improve 1-year cure.

  View details for DOI 10.1016/j.ajog.2011.08.003

  View details for Web of Science ID 000298369200037

  View details for PubMedID 21974992

• New techniques for treating urinary incontinence by stress GIORNALE ITALIANO DI OSTETRICIA E GINECOLOGIA Elliot, C. S., Sokol, E. R. 2011; 33 (3): 121–30

  View details for Web of Science ID 000421662100001

• Variation in the Quality of Surgical Care for Uterovaginal Prolapse 30th Annual Scientific Meeting of the American-Urogynecologic-Society Rhoads, K. F., Sokol, E. R. LIPPINCOTT WILLIAMS & WILKINS. 2011: 46–51

  Abstract

  Pelvic organ prolapse is a common disorder, affecting an estimated 24% of women in the United States, with more than 200,000 surgical procedures performed annually. Current treatment recommendations from the American College of Obstetricians and Gynecologists include pelvic floor reconstruction (or pexy) procedures to correct prolapse, with or without hysterectomy; however, many women are treated by hysterectomy alone.To determine whether hospital characteristics predict compliance with recommended surgical care for uterovaginal prolapse.Retrospective analysis of linked California hospital discharge and financial data. International Classification of Diseases, ninth Edition Clinical Modification codes identified records with a primary diagnosis of prolapse and concomitant coding for surgical procedures. χ2 analysis and multivariable models were used to characterize the associations between hospital characteristics and compliance. Compliant care was defined as prolapse treatment by pelvic floor reconstruction (pexy) procedure with or without hysterectomy. Failed compliance was defined as hysterectomy alone.A total of 28,539 cases in 343 hospitals were analyzed. Low compliance rates were detected in all hospital types, though some were better than others. High-volume (odds ratios [OR] = 1.75; 95% CI: [1.62, 1.89]), teaching (OR = 2.03; 95% CI: [1.84, 2.25]), and private (OR = 1.28; 95% CI: [1.14, 1.46]) hospitals were more likely, while disproportionate share hospitals were less likely (OR = 0.58; 95% CI: [0.54, 0.63]) to comply with evidence-based recommendation.Although we did find significant variation in compliance by hospital characteristics, compliance rates were low in all settings. Quality improvement efforts in the surgical treatment of uterovaginal prolapse should focus on increasing adherence to evidence-based practice.

  View details for DOI 10.1097/MLR.0b013e3181f37fed

  View details for PubMedID 21102358

• Vaginal Mesh for Prolapse A Randomized Controlled Trial OBSTETRICS AND GYNECOLOGY Iglesia, C. B., Sokol, A. I., Sokol, E. R., Kudish, B. I., Gutman, R. E., Peterson, J. L., Shott, S. 2010; 116 (2): 293-303

  Abstract

  To present 3-month outcomes of a double-blind, multicenter randomized controlled trial comparing traditional vaginal prolapse surgery without mesh with vaginal surgery with mesh.Women with pelvic organ prolapse quantification prolapse stages 2-4 were randomized to vaginal colpopexy repair with mesh or traditional vaginal colpopexy without mesh. The primary outcome measure was objective treatment success (pelvic organ prolapse quantification stage 1 or lower) at 3 months. Secondary outcome measures included quality-of-life variables and complication rates.Sixty-five women were recruited from January 2007 to August 2009, when the study was halted due to predetermined stopping criteria for vaginal mesh erosion at a median follow-up of 9.7 months (range, 2.4-26.7 months). Thirty-two women underwent mesh colpopexy (24 anterior mesh, eight total mesh), and 33 women had vaginal colpopexies without mesh (primarily uterosacral ligament suspension) and concurrent colporrhaphy. There were no statistically significant baseline differences between the mesh and no-mesh groups with respect to demographics, menopausal status, and race. Analysis of the mesh and no-mesh women found no difference with respect to overall recurrence (mesh: 19 [59.4%] compared with no mesh: 24 [70.4%], P=.28). There were five (15.6%) vaginal mesh erosions. Two cystotomies and one blood transfusion occurred in the mesh group only. Subjective cure of bulge symptoms was noted in 93.3% of mesh patients and 100% of no-mesh patients. Furthermore, subjective quality-of-life measurements did not differ between the two groups at baseline or 3 months postoperatively.At 3 months, there is a high vaginal mesh erosion rate (15.6%) with no difference in overall objective and subjective cure rates. This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs.Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540.I.

  View details for DOI 10.1097/AOG.0b013e3181e7d7f8

  View details for Web of Science ID 000280186300008

  View details for PubMedID 20664388

• Alternative method of suprapubic assistance in operative cystoscopy INTERNATIONAL UROGYNECOLOGY JOURNAL Chang, P. L., Sokol, E. R. 2010; 21 (2): 247-249

  Abstract

  Complications of tension-free vaginal tape (TVT) procedures have become more prevalent as the procedure has become more popular for the treatment of stress urinary incontinence. A common complication of TVT slings is bladder perforation, which is estimated to occur in 0.7-24% of treated patients. While easily treated if identified intraoperatively, unrecognized bladder perforation generally requires further surgery to correct. We propose a novel minimally invasive technique using the suture passer of the Carter-Thomason CloseSure system for suprapubic assistance during cystoscopic removal of TVT mesh from the bladder. This novel approach allows for the avoidance of an open incision or a larger accessory port placed through the bladder to assist with mesh excision.

  View details for DOI 10.1007/s00192-009-0940-8

  View details for PubMedID 19543675

• Is lysyl oxidase-like protein-1, alpha-1 antitrypsin, and neutrophil elastase site specific in pelvic organ prolapse? INTERNATIONAL UROGYNECOLOGY JOURNAL Man, W. C., Ho, J. Y., Wen, Y., Sokol, E. R., Polan, M. L., Chen, B. 2009; 20 (12): 1423-1429

  Abstract

  We investigated whether the expression of alpha-1 antitrypsin (ATT), neutrophil elastase (NE), and lysyl oxidase-like protein 1 (LOXL-1) vary within the vagina in subjects with pelvic organ prolapse (POP).Biopsies were obtained from the anterior and posterior vaginal wall of 22 women with POP (> or =stage 2 by POP-Q). The subjects were grouped by the most prominent defect: cystocele, cystocele plus uterine prolapse, and rectocele. Comparative real-time PCR, Western blotting, and NE enzyme activity assay were performed.The ratio of anterior and posterior vaginal wall ATT, NE, and LOXL-1 expression varied between individuals within the same defect group.ATT, NE, and LOXl-1 expression was variable among different biopsy sites in the vagina. No consistent pattern was present when the subjects were grouped by the most prominent defect. We recommend careful consideration of biopsy sites in future studies on POP to enhance reproducibility of data.

  View details for DOI 10.1007/s00192-009-0905-y

  View details for PubMedID 19763368

• An Instructional Video to Improve Teaching Techniques and Learning in the Operating Room MedEdPORTAL. Available from: www.aamc.org/mededportal Sokol E, Metheny W, Ward R 2009: 1754
• Novel Repair of Tension-free Midurethral Sling Erosion into the Urethra JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY Sokol, E. R., Urban, R. 2008; 15 (6): 755-757

  Abstract

  Severe urinary tract injury is a relatively uncommon occurrence after the placement of a tension-free vaginal tape sling. Bladder perforation is the most common urinary tract injury, but bladder drainage for a few days is usually the only intervention that is required. Urethral erosions of synthetic sling tapes are much rarer, but can result in more significant sequelae such as voiding dysfunction or fistula formation. A 50-year-old woman had an erosion of a synthetic, tension-free midurethral sling through the urethra. She underwent resection of the sling with closure of the urethral defect. The internal urethral sphincter was used during the primary repair to cover the defect because of periurethral scarring and fibrosis. This technique may reduce the risk of subsequent fistula formation, and may be a less invasive alternative to the use of a Martius interposition flap.

  View details for DOI 10.1016/j.jmig.2008.07.012

  View details for PubMedID 18971143

• Combined trans- and periurethral injections of bulking agents for the treatment of intrinsic sphincter deficiency 32nd Annual Meeting of the American-Association-of-Gynecologic-Laparoscopists Sokol, E. R., Aguilar, V. C., Sung, V. W., Myers, D. L. SPRINGER LONDON LTD. 2008: 643–47

  Abstract

  The purpose of this study was to compare Contigen combined with Durasphere to Contigen injections alone for the treatment of stress urinary incontinence (SUI) with intrinsic sphincter deficiency (ISD). Subjective and objective incontinence outcomes were compared at 2 weeks and 6 months. We compared rates of urinary retention and future incontinence surgery between groups. Thirty-three women underwent combined injections, and 51 underwent Contigen injections. Two weeks postoperatively, more women in the combined group were cured (72.7 vs. 39.2%, P = 0.003), but this difference diminished at 6 months (33.3 vs. 29.4%, P = 0.70). Retention was more common in the combined group (P = 0.002, odds ratio [OR] = 0.062 [95% confidence interval (CI) = 0.007, 0.52]). Twenty-three women in the Contigen and ten in the combined group underwent subsequent incontinence surgery (P = 0.17, OR = 2.03 [95% CI = 0.80, 5.1]). Combining Contigen and Durasphere injections to treat SUI with ISD does not improve outcomes compared to Contigen injections alone.

  View details for DOI 10.1007/s00192-007-0493-7

  View details for PubMedID 17965815

• Is alpha 2-macroglobulin important in female stress urinary incontinence? HUMAN REPRODUCTION Wen, Y., Man, W. C., Sokol, E. R., Polan, M. L., Chen, B. H. 2008; 23 (2): 387-393

  Abstract

  Loss of mechanical stability of the urethra and bladder is thought to be important in the development of stress urinary incontinence (SUI). The vaginal wall is the main supporting tissue for pelvic organs and changes in components of supporting tissues are known to be involved in the pathophysiology of SUI.We evaluated changes in expression of alpha2-macroglobulin (alpha2-M), a protease inhibitor, in vaginal wall tissues from premenopausal women (aged 42-45 years) with SUI (n = 28) compared with menstrual cycle-matched continent women (controls, n = 29). The distribution of alpha2-M in vaginal wall tissues and fibroblasts was analysed by immunohistochemistry and immunofluorescence. Expression levels of alpha2-M mRNA and protein was determined by relative real-time quantitative PCR and enzyme-linked immunosorbent assay, respectively. Protease inhibition was measured to assess bioactivity.Vaginal wall tissues do express alpha2-M. Expression of alpha2-M mRNA and protein was significantly higher in tissues from controls compared to women with SUI in both proliferative and secretory phases (P < 0.05). Protease inhibitory activity of alpha2-M was significantly higher in tissues from controls compared to women with SUI in the secretory phase (P < 0.05), but we found no difference in the proliferative phase between groups. alpha2-M protein level was lower in the proliferative phase than the secretory phase in both controls and SUI patients, while for alpha2-M mRNA this was found only in controls.Decreased expression of alpha2-M mRNA and protein and protease inhibitory activity in the vaginal wall tissues of women with SUI may contribute to the development of SUI.

  View details for DOI 10.1093/humrep/dem370

  View details for PubMedID 18077315

• Long-term follow-up of a transvaginal Burch urethropexy for stress urinary incontinence 33rd Annual Meeting of the Society-of-Gynecological-Surgeons Rardin, C. R., Sung, V. W., Hampton, B. S., Clemons, J. L., Aguilar, V., Sokol, E. R. MOSBY-ELSEVIER. 2007

  Abstract

  The objective of the study was to describe long-term objective and subjective success rates and complications following transvaginal Burch urethropexy for stress urinary incontinence.A case series of 66 women who underwent vaginal Burch urethropexy for urodynamic stress urinary incontinence with urethral hypermobility using a suture carrier device is presented. Concurrent prolapse repairs were performed as indicated.Sixty-six women (mean age 49.4 +/- 12.1 years) underwent vaginal Burch urethropexy. Mean follow-up time was 20.9 +/- 18.9 months. Objective failure was observed in 16 patients (24.2%). Subjective failure was reported by 21.2% of patients, with 50% and 28.8% reporting success and improvement, respectively. Six patients (9%) experienced febrile illness, 4 (6%) experienced intraoperative hemorrhage, 1 (1.5%) received transfusion, and 1 (1.5%) experienced pelvic abscess. Twelve patients (18.2%) experienced suture erosion; half required surgical revision or excision.Vaginal Burch urethropexy is generally well tolerated but is associated with poor long-term success and high suture erosion rates.

  View details for DOI 10.1016/j.ajog.2007.08.060

  View details for Web of Science ID 000251675700039

  View details for PubMedID 18060969

• Variability of current symptoms in women with pelvic organ prolapse 32nd Annual Meeting of the Society-of-Gynecologic-Surgeons Sung, V. W., Clark, M. A., Sokol, E. R., Rardin, C. R., Myers, D. L. SPRINGER LONDON LTD. 2007: 787–98

  Abstract

  To describe the variability of current (day-to-day) symptoms of pelvic organ prolapse (POP) and to compare women's overall (comprehensive) and current ratings of prolapse symptoms. This was a prospective observational study of 45 women with symptomatic POP followed-up for 3 months between November 2004 and June 2005. Women had a total of three visits during the study period. We measured current symptoms using daily symptom diaries completed for a total of 4 weeks during the study period. The diaries included 100-mm visual analogue scales anchored at 0 (no symptoms) and 100 (extremely severe symptoms) and patients completed these at three different times each day. At each study visit, patients were examined and completed a 10-item questionnaire, which included questions adapted from the PFDI. This questionnaire compared overall and current symptoms at each study visit. Statistical analyses included descriptive statistics, ANOVA, and Pearson's correlation coefficient. Current symptoms of vaginal bulging varied on a day-to-day basis. Current symptoms varied depending on the time of day with women reporting more severe symptoms in the evenings (P<.01). Women reported experiencing their most severe symptoms at only 13.7% of all study visits. On average, women reported less severe ratings of current symptoms at the time of each visit compared to overall recall ratings (P<.05). Women seeking care for symptomatic POP can have dynamic symptoms and are often not evaluated at the time of their most severe symptoms. This should be considered by clinicians evaluating women for symptoms of POP.

  View details for DOI 10.1007/s00192-006-0237-0

  View details for Web of Science ID 000247504200015

  View details for PubMedID 17115232

• Does alpha 2-macroglobulin contribute to stress urinary incontinence? Wen, Y., Man, W. C., Sokol, E., Polan, M. L., Chen, B. SPRINGER LONDON LTD. 2007: S14–S15

  View details for Web of Science ID 000248185300025

• Incarcerated vaginal herniation of the omentum mimicking vaginal prolapse. American journal of obstetrics and gynecology Sokol, E. R., Munro, E. G. 2007; 196 (3): e7-8

  Abstract

  We present a 33-year-old woman with a history of radical hysterectomy and pelvic radiation who developed a nonreducible high anterior vaginal wall bulge, postoperative pelvic pain, and dyspareunia. Dynamic MRI revealed herniation of the omentum into the vesico-vaginal space. The incarcerated hernia was repaired transvaginally, and the patient's symptoms improved.

  View details for PubMedID 17346517

• Effect of patient age on increasing morbidity and mortality following urogynecologic surgery Annual Scientific Meeting of the Infectious-Diseases-Society-for-Obstetrics-and-Gynecology Sung, V. W., Weitzen, S., Sokol, E. R., Rardin, C. R., Myers, D. L. MOSBY-ELSEVIER. 2006: 1411–17

  Abstract

  The purpose of this study was to estimate the effect of age on the risk of in-hospital mortality and morbidity following urogynecologic surgery and to compare risks associated with obliterative versus reconstructive procedures for prolapse in elderly women.We conducted a retrospective cohort study utilizing data from 1998 to 2002 from the Nationwide Inpatient Sample. Multivariable logistic regression was performed to obtain odds ratios estimating the effect of age on risk of death and complications, adjusting for comorbidities and demographic factors.There were 264,340 women in our study population. Increasing age was associated with higher mortality risks per 1000 women (< 60 years, 0.1; 60-69 years, 0.5; 70-79 years, 0.9; > or = 80 years, 2.8; P < .01) and higher complication risks per 1000 women (< 60 years, 140; 60-69 years, 130; 70-79 years, 160; > or = 80 years, 200; P < .01). Using multivariable logistic regression, increasing age was associated with an increased risk of death (60-69 years, odds ratio [OR] 3.4 [95% CI 1.7-6.9]; 70-79 years, OR 4.9 [95% CI 2.2-10.9]; > or = 80 years, OR 13.6 [95% CI 5.9-31.4]), compared with women < 60 years. The risk of peri-operative complications was also higher in elderly women 80 years of age and older (OR 1.4 [95% CI 1.3-1.5]) compared with younger women. Elderly women 80 years and over who underwent obliterative procedures had a lower risk of complication compared with those who underwent reconstructive procedures for prolapse (17.0% vs 24.7%, P < .01).Although the absolute risk of death is low, elderly women have a higher risk of mortality and morbidity following urogynecologic surgery.

  View details for DOI 10.1016/j.ajog.2006.01.050

  View details for Web of Science ID 000237331900035

  View details for PubMedID 16647926

• The usefulness of urinary cytology testing in the evaluation of irritative voiding symptoms Joint Annual Meeting of the American-Urogynecologic-Society/Society-of-Gynecologic-Surgeons Sokol, E. R., Patel, S. R., Clemons, J. L., Sung, V. W., Rardin, C. R., Myers, D. L. MOSBY-ELSEVIER. 2005: 1554–59

  Abstract

  The purpose of this study was to assess the clinical usefulness of urinary cytology testing for the evaluation of urothelial cancer in women with irritative voiding symptoms who were examined at a urogynecology service.Urinary cytology studies results that were obtained from January 1, 2000, to December 31, 2002, were cross-matched with the Rhode Island Department of Health Cancer Registry to identify those women who were diagnosed with urinary tract malignancies. The prevalence of urothelial cancer was determined, and the sensitivity, specificity, and positive and negative predictive values of urinary cytologic testing were calculated for 2 common classification strategies: (1) consideration of atypical cytologic test results to be normal and (2) consideration of atypical cytologic test results to be abnormal.Among 1516 cross-matched cytologic test results from 1324 patients, 5 urothelial cancers were identified. Two of the 5 malignancies were associated with positive cytology results. The prevalence of urothelial cancer was 0.38% (95% CI, 0.1%, 0.9%). When atypical cytology studies were classified as normal, the sensitivity of urinary cytology was 40% (95% CI, 7.2%, 83.0%); the specificity was 99.9% (95% CI, 99.5%, 100%); the positive predictive value was 66.7% (95% CI, 12.5%, 98.2%), and negative predictive value was 99.8% (95% CI, 99.2%, 100%). In contrast, when atypical cytology results were classified as abnormal, the sensitivity and negative predictive value remained the same, but the specificity declined to 93.6% (95% CI, 92.1%, 94.8%), and the positive predictive value decreased to 2.3% (95% CI, 0.4%, 8.8%).The low prevalence of urothelial cancers and low sensitivity of urinary cytology studies severely limit the usefulness of this test in the evaluation of women with irritative voiding symptoms.

  View details for DOI 10.1016/j.ajog.2004.10.627

  View details for Web of Science ID 000229384100049

  View details for PubMedID 15902157

• Suburethral sting treatment of occult stress incontinence and intrinsic sphincter deficiency in women with severe vaginal prolapse of the anterior vs posterior/apical compartment Joint Annual Meeting of the American-Urogynecologic-Society/Society-of-Gynecologic-Surgeons Clemons, J. L., Aguilar, V. C., Sokol, E. R., Sung, V. W., Myers, D. L. MOSBY-ELSEVIER. 2005: 1566–72

  Abstract

  The purpose of this study was to compare the efficacy of a Mersilene mesh suburethral sling for occult stress urinary incontinence (SUI) and intrinsic sphincter deficiency (ISD) in women with severe vaginal prolapse of the anterior compartment to the posterior/apical compartment.This was a retrospective study that compared women with stage or grade III/IV prolapse of the anterior compartment (group 1) with the posterior/apical compartment (group 2); both groups demonstrated occult SUI (leakage only with prolapse reduced) and ISD on urodynamics, and underwent concurrent pelvic reconstructive surgery. The sling was defined as efficacious if SUI was prevented in 85% of women and if obstructive symptoms (de novo or worsening urge incontinence, or urinary retention greater than 2 weeks) occurred in less than 10% of women.There were 39 women in group 1 and 25 women in group 2. There were no differences between women in group 1 or group 2 in preoperative demographics (except parity) or urodynamic findings. SUI cure rates were lower for group 1 than group 2, but this difference was not significant (87% vs 100%, P = .15). Rates of de novo or worsening urge incontinence (8% vs 4%, P = 1.00) and urinary retention (none occurred) were similar between groups.In women with severe vaginal prolapse, slings effectively treat occult SUI and ISD, whether associated with anterior or posterior/apical prolapse.

  View details for DOI 10.1016/j.ajog.2004.11.041

  View details for Web of Science ID 000229384100051

  View details for PubMedID 15902159

• Results of urine cytology testing and cystoscopy in women with irritative voiding symptoms Joint Annual Meeting of the American-Urogynecologic-Society/Society-of-Gynecologic-Surgeons Sokol, E. R., Pate, S. R., Sung, V. W., Rardin, C. R., Weitzen, S., Clemons, J. L., Myers, D. L. MOSBY-ELSEVIER. 2005: 1560–65

  Abstract

  The purpose of this study was to assess rates of urinary cytologic abnormalities and cystoscopic outcomes in women with irritative voiding symptoms who were examined at a urogynecology clinic.All urinary cytology studies results that were sent between January 1, 2000, and July 31, 2003, for the evaluation of irritative voiding symptoms were reviewed. Data were then extracted from the charts of a subset of these patients to evaluate cystoscopic outcomes. Demographics, risk factors for urothelial cancer, laboratory results, and radiology imaging results were then analyzed and compared between patients with and without abnormal cytology and cystoscopic results.Of the 1783 total urinary cytology that were reviewed, 1661 test results were read as normal (93.2%); 112 test results (6.3%) were read as atypical, and 3 test results (0.2%) were read as unsatisfactory. Seven cytologic test results were categorized as suspicious or malignant, which accounts for only 0.4% of all cytologic test results that were sent. Of the 564 consecutive women whose cases were chosen for subanalysis, cytology was normal in 91.5% and atypical in 8.5% of cases. No cytology were suspicious or malignant. Cystoscopic findings were normal in 548 patients (97.2%). Only 1 patient (0.2%) received a diagnosis of transitional cell carcinoma.Urinary cytology and cystoscopy are low yield tests and should not be used routinely in the initial evaluation of women with irritative voiding symptoms.

  View details for DOI 10.1016/j.ajog.2004.10.629

  View details for Web of Science ID 000229384100050

  View details for PubMedID 15902158

• Patient characteristics that are associated with continued pessary use versus surgery after 1 year 24th Annual Meeting of the American-Urogynecologic-Society Clemons, J. L., Aguilar, V. C., Sokol, E. R., Jackson, N. D., Myers, D. L. MOSBY-ELSEVIER. 2004: 159–64

  Abstract

  The purpose of this study was to identify patient characteristics in women with symptomatic pelvic organ prolapse that is associated with continued pessary use versus surgery after 1 year.Fifty-nine women with symptomatic pelvic organ prolapse who were satisfied with their pessary at 2 months were evaluated prospectively at 1 year. Characteristics of women who continued to use a pessary were compared with women who underwent pelvic reconstructive surgery to identify predictors for continued pessary use versus surgery.Forty-three women (73%) continued pessary use, and 16 women (27%) underwent surgery. Characteristics that were associated with continued pessary use were older age (76 vs 61 years; p <.001) and poor surgical risk (26% vs 0%; P =.03). Characteristics that were associated with surgery were sexual activity (81% vs 26%; P <.001), stress incontinence (44% vs 16%; P =.03), stage III-IV posterior vaginal wall prolapse (44% vs 16%; P =.03), and desire for surgery at the first visit (63% vs 12%; P <.001). Age >or=65 years was the best cut-off value for continued pessary use, with sensitivity of 95% (95% CI, 84%, 99%) and a positive predictive value of 87% (95% CI, 74%, 94%). Logistic regression demonstrated that age >or=65 years ( P <.001), stage III-IV posterior vaginal wall prolapse ( P =.007), and desire for surgery ( P =.04) were independent predictors.Age >or=65 years was associated highly with continued pessary use. Desire for surgery and stage III-IV posterior vaginal wall prolapse were associated with discontinued pessary use and pelvic reconstructive surgery.

  View details for DOI 10.1016/j.ajog.2004.04.048

  View details for Web of Science ID 000223139100024

  View details for PubMedID 15295358

• Ultrasound examination of the postpartum uterus: what is normal? journal of maternal-fetal & neonatal medicine Sokol, E. R., Casele, H., Haney, E. I. 2004; 15 (2): 95-99

  Abstract

  To establish normal ultrasonographic findings for the postpartum uterus after vaginal delivery, and to characterize associated bleeding patterns.Postpartum women were scanned by transabdominal ultrasound within 48 h after normal vaginal delivery. Uterine length, uterine width, endometrial stripe thickness and endometrial contents were evaluated by a single sonographer. Patients maintained a daily symptom diary for 6 weeks and were interviewed by telephone at 2 weeks. Statistical analysis was performed using chi2, Fisher's exact test, Student's t test and Pearson correlation.Mean endometrial stripe thickness was 1.1 +/- 0.6 cm, mean uterine length was 16.1 +/- 1.7 cm and mean uterine width was 8.7 +/- 1.0 cm. Postpartum bleeding requiring more than four protective pads per day for > or =10 days was associated with a thicker endometrial stripe (1.5 +/- 0.7 cm vs. 0.9 +/- 0.4 cm, p = 0.006). However, no patients experienced postpartum bleeding complications requiring intervention. Of the 40 women evaluated, 16 had echogenic material in the uterine cavity (mean size 12.7 +/- 6.9 cm2). The presence of echogenic material was not associated with the amount or duration of bleeding.Frequent postpartum ultrasonographic findings include a thickened endometrial stripe and echogenic material in the uterine cavity. The echogenic material commonly seen in the endometrial cavity of asymptomatic patients was not associated with the development of bleeding complications.

  View details for PubMedID 15209115

• Laparoscopic morcellator-related injuries 31st Annual Meeting of the American-Association-of-Gynecologic-Laparoscopists Milad, M. P., Sokol, E. JOURNAL AMER ASSOC GYNECOLOGIC LAPAROSCOPISTS. 2003: 383–85

  Abstract

  To identify and summarize all electric morcellator-related injuries published in the medical literature.Systematic review (Canadian Task Force classification II-2).Databases.Articles on morcellator-related injuries published from 1992 through February 2002, plus additional sources of information.Search of MEDLINE and referencing of the FDA device report database. Measurements and Main Results: We were unable to locate any references to morcellator-related visceral injuries in the medical literature. Of 17 cases identified from the FDA database, 3 were excluded based on the trivial nature of the event (e.g., instrument did not function). The remaining 14 visceral injuries were to small and large bowel (11), kidney (2), pancreas (1), and major vascular structures (3). Identification of the complication was immediate in 10 patients, but was not until 4 days postoperatively in 1 woman. Three patients died. No device manufacturer or surgical specialty was responsible for a preponderance of the injuries.These potentially fatal complications are unreported in the medical literature.

  View details for Web of Science ID 000188064600016

  View details for PubMedID 14567817