A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair.

BACKGROUND: The choice of midurethral sling type may impact efficacy and complications in women undergoing transvaginal native tissue repair of pelvic organ prolapse. OBJECTIVE: The primary aim was to determine if the single-incision sling is noninferior to retropubic sling for the management of stress urinary incontinence among patients undergoing reconstructive or obliterative native tissue vaginal repair. The secondary aims were to compare adverse events and surgeon ease of use with sling assignment. STUDY DESIGN: A multicenter, noninferiority, randomized trial of women with ≥ stage II pelvic organ prolapse and objectively confirmed stress urinary incontinence undergoing reconstructive or obliterative vaginal repair was performed. Women were randomized to concomitant single-incision (Altis sling, Coloplast Minneapolis, MN) with suprapubic sham incisions or retropubic slings. The primary dichotomous outcome was abnormal lower urinary tract function within 12 months postsurgery, defined as bothersome stress urinary incontinence symptoms (>1 Pelvic Floor Distress Inventory question no. 17); retreatment for stress urinary incontinence or treatment for urinary retention. Secondary outcomes were adverse events, Patient Global Impression of Improvement of bladder function, and surgeon ease of use (1, worst; 10, best). All subjects completed validated questionnaires and underwent a Pelvic Organ Prolapse Quantification, cough stress test, and postvoid residual preoperatively, at 6 weeks and 12 months postoperatively. Assuming a subjective cure rate for retropubic of 82%, 80% power, and 1-sided 5% significance level, we estimated that 127 patients in each arm were needed to declare noninferiority of the single-incision sling if the upper bound of the 95% confidence interval for the between-group difference per protocol in abnormal bladder function was <12%. Assuming a 10% loss to follow-up, the total enrollment goal was 280. RESULTS: Between December 2018 and January 2023, 280 subjects were enrolled across 7 sites, and 255 were randomized: 126 were for single-incision, and 129 were for retropubic sling. There were no preoperative or operative characteristic differences between groups. Overall, 81% had reconstructive, and 19% had obliterative native tissue repairs. The primary outcome, abnormal lower urinary tract function at 12 months, occurred in 29 (25%) of single-incision vs 24 (20%) of the retropubic sling group (risk difference, 0.04472 [95% confidence interval, -0.03 to 0.1133]; P=.001 for noninferiority). Bothersome stress urinary incontinence occurred in 20% vs 17% (P=.27) and was retreated in 4% vs 2% (P=.44) of single-incision vs retropubic groups, respectively. Adverse events were reported in 24 (16%) of single-incision vs 14 (9%) of the retropubic group (95% confidence interval, 0.95-3.29; P=.70) and included de novo or worsening urgency incontinence symptoms, urinary tract infection, mesh exposure, need for prolonged catheter drainage, and de novo pain, without differences between groups. Patient Global Impression of Improvement (very satisfied and satisfied) was 71% vs 67% (P=.43), and median surgeon ease of sling use was 8 (7-10) vs 9 (8-10), P=.03 in single-incision vs retropubic, respectively. CONCLUSION: For women undergoing vaginal repair, single-incision was noninferior to retropubic sling for stress urinary incontinence symptoms, and complications, including treatment for urinary retention, did not differ.

Assessing the Impact of Vaginal Hysterectomy with Vaginal Mesh Attachment on Outcomes and Complications during Minimally Invasive Sacrocolpopexy.

STUDY OBJECTIVE: To compare mesh complications and failure rates after 1 year in laparoscopic minimally invasive sacrocolpopexy (MISC) with ultralightweight mesh attached vaginally during total vaginal hysterectomy (TVH), laparoscopically if posthysterectomy (PH), or laparoscopically during supracervical hysterectomy. DESIGN: Single-center retrospective cohort study. SETTING: Tertiary referral center. PATIENTS: Women with symptomatic pelvic organ prolapse who elected for MISC. INTERVENTIONS: Laparoscopic MISC with ultralightweight mesh attached vaginally during TVH, laparoscopically if PH, or laparoscopically during supracervical hysterectomy. Composite failure was defined as recurrent prolapse symptoms, prolapse past the hymen, or retreatment for prolapse. MEASUREMENTS AND MAIN RESULTS: Between 2010 and 2017, 650 patients met the inclusion criteria with 278 PH, 82 supracervical hysterectomy, and 290 vaginal hysterectomy patients. Median follow-up was similar for all groups (382 days vs 379 vs 345; p = .31). The majority in all groups were white (66.6%), nonsmokers (74.8%), postmenopausal (82.5%), and did not use estrogen (70.3%). Mesh complications did not differ among groups (1.6% PH, 2.5% supracervical hysterectomy, 2.2% vaginal hysterectomy; p >.99). There was no difference in anatomic failure (5% PH, 1.2% supracervical hysterectomy, 2.1% vaginal hysterectomy; p = .07), reoperation for prolapse (1.4% vs 1.2% vs 0.7%; p = .57), or composite failure (9.0% vs 3.7% vs 4.8%; p = .07). CONCLUSIONS: TVH with vaginal mesh attachment of ultralightweight mesh had similar adverse events, mesh exposure rates, and failure rates to those of laparoscopic PH sacrocolpopexy or supracervical hysterectomy with laparoscopic mesh attachment.

Mesh Exposure Following Vaginal Versus Laparoscopic Hysterectomy at the Time of Sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: To compare vaginal mesh exposure rates, adverse events and composite failure within 1 year postoperatively in patients who undergo vaginal hysterectomy with vaginal mesh attachment (TVH) versus laparoscopic hysterectomy with abdominal mesh attachment (TLH) for minimally invasive sacrocolpopexy. METHODS: This multicenter retrospective cohort study is a secondary analysis of data collected retrospectively at one institution and the multicenter randomized control PACT trial. Women were excluded for no follow-up between 9 months and 2 years postoperatively or undergoing concurrent non-urogynecologic procedures. RESULTS: Between 2010 and 2019, 182 patients underwent TLH and 132 TVH. There were 15 (4.8%) vaginal mesh exposures: 12 (6.6%) in the TLH and 3 (2.3%) in the TVH group (p = 0.133) with zero mesh erosions. Logistic regression analysis for mesh exposure in the TLH vs. TVH groups controlling for BMI, posterior repair and surgeon training also showed no significant difference (OR 4.8, 95% CI 0.94, 24.8, p = 0.059). The overall intraoperative complication rate was low (19/314, 6.1%) with a higher rate of bladder injury in the TLH group (4.4% vs. 0.8%, p = 0.049). The TLH group had a higher rate of UTI (8.2% vs. 2.3%, p = 0.027) and clean intermittent catheterization (11% vs. 3%, p = 0.009). At 1-year follow-up, there was no difference in composite failure (6%), bulge symptoms (5%) or retreatment (1%) between groups. CONCLUSIONS: At 1 year, there is no significant difference in vaginal mesh exposure rates between vaginal hysterectomy with vaginal mesh attachment and laparoscopic hysterectomy with abdominal mesh attachment. Both groups have equal efficacy with low rates of complications.

Treatment of refractory overactive bladder with OnabotulinumtoxinA vs PTNS: TROOP trial.

INTRODUCTION AND HYPOTHESIS: We hypothesized that patients with refractory overactive bladder (rOAB) have similar improvement with percutaneous tibial nerve stimulation (PTNS) and OnabotulinumtoxinA (BTX). METHODS: This multicenter cohort study compared BTX and PTNS in women with rOAB. Baseline information included Overactive Bladder Questionnaire (OABq) short form, Urinary Distress Inventory-6 (UDI-6), and voiding diary. Primary outcome was cure, defined as "very much better" or "much better" on the Patient Global Impression of Improvement (PGII) AND a reduction in OABq symptom severity scale (SSS) ≥10 at 3 months after treatment. Assuming 80% power to detect a ten-point difference in OABq-SSS, 80 participants were required per group. RESULTS: A total of 150 patients were enrolled; 97 completed 3 months of therapy and were included. At baseline, BTX patients had more detrusor overactivity (70% vs 40%, p = 0.025), urgency incontinence (UUI; OABq-SSS#6 4 vs 3, p = 0.02, SSS 65 vs 56, p = 0.04), but similar health-related quality of life (HRQL 49 vs 54, p = 0.28), voids (7 vs 8, p = 0.13), and UUI episodes (2 vs 2, p = 1.0). At 3 months, cure rates were similar: BTX 50% vs PTNS 44.2% (p = 0.56). Both groups had improved SSS (-37 vs -29, p = 0.08) and HRQL (31 vs 24, p = 0.14). Patients receiving BTX had a greater improvement in urgency (ΔOABq-SSS#2-3 vs -2; p = 0.02) and UUI (ΔOABq-SSS#6-2 vs -1; p = 0.02). No characteristics were predictive of cure. CONCLUSIONS: BTX resulted in significantly greater improvement in urgency and UUI than PTNS, but no difference in success based on PGII and OABq-SSS, which may be due to a lack of power.

Perioperative outcomes following pelvic floor reconstruction in women with hereditary disorders of connective tissue: a retrospective cohort study.

INTRODUCTION AND HYPOTHESIS: Women with hereditary disorders of connective tissue (HDCT) are at increased risk of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). We hypothesized that patients would have increased incidence and severity of perioperative complications up to 6 weeks after surgeries for POP/SUI. Secondary objectives were to compare pre- and post-operative pelvic floor symptoms and anatomical support as well as pelvic floor disorder recurrence. METHODS: In this multi-center retrospective cohort study, we identified patients with HDCTs by patient history and ICD-9 codes over an 11-year period. Controls without HDCTs were matched 2:1 to the primary POP or SUI procedure and surgeon. Demographic characteristics, perioperative pelvic floor information and complications were collected. A sample size of 65 HDCT patients and 130 controls was calculated to detect a 20% difference in complications with 80% power and alpha of 0.05. RESULTS: We identified 59 HDCT patients and 118 controls. Of the women with HDCTs, 49% had Ehlers-Danlos, 22% joint hypermobility syndrome, 15% Marfan syndrome, and 14% had others. Compared with controls, HDCT patients had more total perioperative complications (46% vs 22%, p = 0.002); an age-adjusted relative risk of complications was 1.4 (CI 0.7-2.6). HDCT patients had more Clavien-Dindo grades I and II complications (p = 0.02, 0.03) and more hospital readmissions (14% vs 3%, p = 0.01) than controls. There was no difference in the incidence of specific complications nor was there a difference in recurrence of POP (10%) or SUI (11%) between groups. CONCLUSIONS: Patients with HDCTs had more Clavien-Dindo grade I and II complications following pelvic floor reconstructive surgery and more readmissions.

Hysterectomy Complications Relative to HbA1c Levels: Identifying a Threshold for Surgical Planning.

STUDY OBJECTIVE: To evaluate whether diabetes diagnosis and level of diabetes control as reflected by higher preoperative glycosylated hemoglobin (HbA1c) levels are associated with increased complication rates after hysterectomy and to identify a threshold of preoperative HbA1c level past which we should consider delaying surgery owing to increased risk of complications. DESIGN: Retrospective cohort study. SETTING: Hospitals in the Michigan Surgical Quality Collaborative between June 4, 2012, and October 17, 2017. PATIENTS: Women with and without a diabetes diagnosis. INTERVENTIONS: Hysterectomy. MEASUREMENTS AND MAIN RESULTS: Data on demographics, preoperative HbA1c values, surgical approach, composite postoperative complications, readmissions, emergency department visits, and reoperations were abstracted. The risk of a postoperative complication when diabetes was stratified by preoperative HbA1c level was evaluated in a sensitivity analysis, and independent associations were identified in a mixed, multivariate logistic regression model. We identified 41 286 hysterectomies performed at 70 hospitals to be included for analysis. The sensitivity analysis identified 4 groups of risk for postoperative complications: group 1: no diabetes diagnosis and no HbA1c value; group 2: no diabetes diagnosis, with HbA1c levels between 4% and 6.5%; group 3: diabetes diagnosis and no HbA1c value or HbA1c levels <9%; and group 4: diabetes diagnosis with HbA1c levels ≥9%. In the adjusted model, there were significant 32% and 34% increased odds of postoperative complications for groups 2 and 3, respectively, compared with group 1. There were more than 2-fold increased odds of complications for women with diabetes and a preoperative HbA1c level ≥9% (group 4) compared with the women in group 1. Diabetes diagnosis with preoperative HbA1c levels ≥9% had increased odds of complications compared with diabetes diagnosis with preoperative HbA1c levels <9%. Patients with well-controlled diabetes seemed to have increased odds of complications with laparoscopic surgery. CONCLUSION: Diabetes diagnosis and measurement of preoperative HbA1c levels provide risk stratification for postoperative complications after hysterectomy, with the highest observed effect among patients with diabetes with a preoperative HbA1c level ≥9%.

A multicenter retrospective cohort study comparing urethral diverticulectomy with and without pubovaginal sling.

BACKGROUND: Urethral diverticulum is a rare entity and requires a high suspicion for diagnosis based on symptoms and physical exam with confirmation by imaging. A common presenting symptom is stress urinary incontinence (SUI). The recommended treatment is surgical excision with urethral diverticulectomy. Postoperatively, approximately 37% of patients may have persistent and 16% may have de novo SUI. An autologous fascial pubovaginal sling (PVS) placed at the time of urethral diverticulectomy (UD) has the potential to prevent and treat postoperative SUI. However, little has been published about the safety and efficacy of a concomitant pubovaginal sling. OBJECTIVE: The objective of this study was to compare the clinical presentation, outcomes, complications, and diverticulum recurrence rates in women who underwent a urethral diverticulectomy with vs without a concurrent pubovaginal sling. STUDY DESIGN: This multicenter, retrospective cohort study included women who underwent a urethral diverticulectomy between January 1, 2000, and December 31, 2016. Study participants were identified by Current Procedure Terminology codes, and their records were reviewed for demographics, medical or surgical history, symptoms, preoperative testing, concomitant surgeries, and postoperative outcomes. Symptoms, recurrence rates, and complications were compared between women with and without a concomitant pubovaginal sling. The primary outcome was the presence of postoperative stress urinary incontinence symptoms. Based on a stress urinary incontinence rate of 50% with no pubovaginal sling and 10% with a pubovaginal sling, we needed a sample size of 141 participants who underwent diverticulectomy without a pubovaginal sling and 8 participants with a pubovaginal sling to achieve 83% power with P<.05. RESULTS: We identified 485 diverticulectomy cases from 11 institutions who met the inclusion criteria; of these, 96 (19.7%) cases had a concomitant pubovaginal sling. Women with a pubovaginal sling were older than those without a pubovaginal sling (53 years vs 46 years; P<.001), and a greater number of women with pubovaginal sling had undergone diverticulectomy previously (31% vs 8%; P<.001). Postoperative follow-up period (14.6±26.9 months) was similar between the groups. The pubovaginal sling group had greater preoperative stress urinary incontinence (71% vs 33%; P<.0001), dysuria (47% vs 30%; P=.002), and recurrent urinary tract infection (49% vs 33%; P=.004). The addition of a pubovaginal sling at the time of diverticulectomy significantly improved the odds of stress urinary incontinence resolution after adjusting for prior diverticulectomy, prior incontinence surgery, age, race, and parity (adjusted odds ratio, 2.27; 95% confidence interval, 1.02-5.03; P=.043). It was not significantly protective against de novo stress urinary incontinence (adjusted odds ratio, 0.86; 95% confidence interval, 0.25-2.92; P=.807). Concomitant pubovaginal sling increased the odds of postoperative short-term (<6 weeks) urinary retention (adjusted odds ratio, 2.5; 95% confidence interval, 1.04-6.22; P=.039) and long-term urinary retention (>6 weeks) (adjusted odds ratio, 6.98; 95% confidence interval, 2.20-22.11; P=.001), as well as recurrent urinary tract infections (adjusted odds ratio, 3.27; 95% confidence interval, 1.26-7.76; P=.013). There was no significant risk to develop a de novo overactive bladder (adjusted odds ratio, 1.48; 95% confidence interval, 0.56-3.91; P=.423) or urgency urinary incontinence (adjusted odds ratio, 1.47; 95% confidence interval, 0.71-3.06; P=.30). A concomitant pubovaginal sling was not protective against a recurrent diverticulum (adjusted odds ratio, 1.38; 95% confidence interval, 0.67-2.82; P=.374). Overall, the diverticulum recurrence rate was 10.1% and did not differ between the groups. CONCLUSION: This large retrospective cohort study demonstrated a greater resolution of stress urinary incontinence with the addition of a pubovaginal sling at the time of a urethral diverticulectomy. There was a considerable risk of postoperative urinary retention and recurrent urinary tract infections in the pubovaginal sling group.

Hysteropexy: an Option for the Repair of Pelvic Organ Prolapse.

PURPOSE OF REVIEW: Women have an estimated 12.6% lifetime risk of undergoing surgery for pelvic organ prolapse in the USA (Wu et al. in Obstet Gynecol 123(6): 1201-6, 2014). Surgical repair of uterovaginal prolapse most commonly includes hysterectomy and vaginal vault suspension; however, the value of concomitant hysterectomy is uncertain, and there appears to be growing interest in uterine conservation. Multiple procedures have evolved using a variety of approaches. The aim of this paper is to review uterine sparing (hysteropexy) prolapse repair techniques and outcomes. RECENT FINDINGS: Several randomized controlled trials (RCT) have shown comparable success rates for apical compartment support with sacrospinous hysteropexy as compared to vaginal hysterectomy with uterosacral ligament suspension, with shorter hospitalization and quicker return to work. (Detollenaere et al. in BMJ 351: h3717, 2015); (Dietz et al. in Int Urogynecol J Pelvic Floor Dysfunct 21(2): 209-16, 2010). Available data suggest vaginal mesh hysteropexy is as effective as vaginal mesh with hysterectomy, with lower rates of mesh exposure. (Maher et al., 2017) To date, no RCTs have been published comparing sacral hysteropexy to hysterectomy with sacral colpopexy. Overall, there is a higher reoperation rate for sacral hysteropexy and a higher mesh exposure rate for hysterectomy with sacral colpopexy. (Maher et al., 2017) No RCTs have been published comparing hysteropexy surgical approaches. Although hysteropexy data is expanding, there is a need for more information regarding long-term surgical durability, appropriate patient selection, and whether one approach is superior to another.

Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study.

BACKGROUND: There is growing interest in uterine conservation at the time of surgery for uterovaginal prolapse, but limited data compare different types of hysteropexy. OBJECTIVE: We sought to compare 1-year efficacy and safety of laparoscopic sacral hysteropexy and vaginal mesh hysteropexy. STUDY DESIGN: 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. RESULTS: 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. CONCLUSION: Laparoscopic sacral hysteropexy and vaginal mesh hysteropexy had similar 1-year cure rates and high satisfaction.

Defining Cervical Elongation: A Prospective Observational Study.

OBJECTIVES: Our primary aim was to define cervical elongation (CE) using the following methods: (1) measurement of pathology specimen, (2) physician perception, (3) intraoperative estimate of anterior cervical length, and (4) office Pelvic Organ Prolapse Quantification (POP-Q) points C and D. Our secondary aim was to determine whether these definitions correlate with perioperative outcomes. METHODS: Women undergoing vaginal hysterectomy and prolapse repair were enrolled. Office POP-Q measurements were collected. Estimates of cervical length were made based on points C minus D of the POP-Q and by manual exam using the surgeon's index and middle fingers. Cervical dimensions were measured from the pathology specimen at the end of the case. CE was defined as one standard deviation (SD) above the mean for each definition. Additional intraoperative data was collected to determine the surgeon perception of cervical anatomy. RESULTS: A total of 90 patients were enrolled during the study period. Our definitions for CE were as follows: (1) 5 cm (70 without and 20 with CE), (2) physician perception (67 without and 23 with CE), (3) 3.4 cm (79 without and 11 with CE), and (4) 8.3 cm (77 without and 13 with CE). After controlling for uterine weight and the presence of fibroids, the operative time was the only outcome measure that remained elevated for patients with CE using our first definition (42.4 ± 20.1 without vs. 53.8 ± 19.2 with CE, P = 0.03). CONCLUSIONS: CE using our first definition was associated with a statistically significant increase in operative time in women undergoing hysterectomy at the time of prolapse repair.

Does the uterus need to be removed to correct uterovaginal prolapse?

PURPOSE OF REVIEW: Owing to growing interest in uterine preservation, this evidence-based review compares hysteropexy with hysterectomy during surgery for uterovaginal prolapse. RECENT FINDINGS: LeFort colpocleisis is preferred over vaginal hysterectomy and total colpocleisis. The majority of studies show no differences in outcomes comparing sacrospinous hysteropexy with vaginal hysterectomy native tissue prolapse repair except for a single randomized controlled trial showing increased apical recurrences with advanced prolapse. Results comparing uterosacral hysteropexy and sacral hysteropexy with hysterectomy native tissue repairs are inconclusive. Potentially better outcomes are reported when laparoscopic hysterectomy (total or supracervical) is performed with sacral colpopexy compared with laparoscopic sacral hysteropexy, but mesh and morcellation risks should be considered. Data comparing vaginal mesh hysteropexy with currently available products with hysterectomy prolapse repairs are lacking but a high-quality study is underway. SUMMARY: High satisfaction and low reoperation rates can be accomplished using a variety of hysteropexy techniques. The advantages and disadvantages of uterine conservation must be considered when planning uterovaginal prolapse surgery. The type of hysteropexy and possible graft configuration may impact reoperation rates for recurrent prolapse. Vaginal mesh risks must be considered and laparoscopic mesh risks must be balanced with potential difficulty of future hysterectomy if needed.

The effect of hydroxyquinoline-based gel on pessary-associated bacterial vaginosis: a multicenter randomized controlled trial.

OBJECTIVE: Pessaries are important options for women with pelvic floor disorders, but many pessary users experience bacterial vaginosis (BV). The aim of this study was to evaluate the effect of TrimoSan gel (Milex Pessaries, Cooper Surgical, Trumbull, CT) on BV prevalence among pessary users. STUDY DESIGN: Women presenting for a pessary fitting completed questionnaires on vaginal symptoms and hormone therapy use and underwent a BV BLUE test and slide collection for BV analysis by Nugent's criteria. Following pessary fitting, women were randomized to either standard pessary care with the use of TrimoSan placed vaginally twice weekly or to standard pessary care without TrimoSan gel. Women returned 2 weeks and 3 months later for a repeat slide collection for Gram stain, BV BLUE testing, and completion of questionnaires on vaginal symptoms and desire to continue the pessary. RESULTS: There were 184 women randomized after successful fitting (92 to the TrimoSan group), and 147 (79%) presented for 3-month follow up. Mean age was 56 ± 16 years; patients were mostly white (57%) or Hispanic (23%), and 36% were using hormone therapy. The groups did not differ in the prevalence of BV by Nugent's criteria at 2 weeks (20% TrimoSan vs 26% no gel, P = .46) or 3 months (24% TrimoSan vs 23% no gel, P = .82), nor did they differ in BV by BV BLUE testing at 2 weeks (0% TrimoSan vs 4% no gel, P = .12) or 3 months (3% TrimoSan vs 0% no gel, P = .15). The prevalence of at least one vaginal symptom did not differ between groups at 2 weeks (44% TrimoSan vs 45% no gel, P = .98) or 3 months (42% TrimoSan vs 32% no gel, P = .30). The TrimoSan group was equally likely to want to continue their pessary use compared with the standard care group at 2 weeks (90% vs 86%, P = .64) and 3 months (63% vs 60%, P = .76). CONCLUSION: TrimoSan gel in the first 3 months of pessary use does not decrease the prevalence of BV or vaginal symptoms and does not alter the likelihood of a woman desiring to continue pessary use.

Knowledge of erectile dysfunction and pelvic floor disorders among young adults: a cross-sectional study.

INTRODUCTION: The prevalence of pelvic floor disorders (PFD) in aging women is comparable to the prevalence of erectile dysfunction (ED) in aging men. The objective of this study was to assess young adults' familiarity with the definition, prevalence, etiology, and treatment of PFD and ED. MATERIALS AND METHODS: Women and men aged 18-40 years completed a validated survey (Prolapse and Incontinence Knowledge Quiz) to assess knowledge of urinary incontinence (UI) and pelvic organ prolapse (POP). Both groups completed a similar questionnaire created to assess knowledge of ED. Participants were asked to estimate the prevalence of these conditions and to identify their source(s) of knowledge. RESULTS: Of 377 respondents, 65% were female and 35% were male. Respondents underestimated the prevalence of these disorders and were significantly worse at estimating the prevalence of PFD than ED. Men and women had significantly less knowledge of POP (67% +/- 32, compared to ED (83% +/- 20) and UI (82% +/- 22), p < 0.001). Men and women did not differ in their knowledge about UI and POP, but men had significantly more knowledge about ED than women (87% +/- 18 versus 81% +/- 21, p = 0.008). Higher education level and increased age were associated with better knowledge of PFD and ED. CONCLUSIONS: Despite high education levels, young adults in our study had a worse understanding of POP compared to UI or ED. Women knew more about ED than about POP, a condition that may affect them during their lifetime.

Significance of cystoscopic bladder trabeculations in women undergoing midurethral sling.

INTRODUCTION: To determine the significance of bladder trabeculations seen on preoperative cystoscopy prior to midurethral sling surgery with respect to lower urinary tract symptoms and sling outcomes. MATERIALS AND METHODS: This retrospective study included women with preoperative cystoscopy who underwent midurethral slings for urinary incontinence from 2006-2009. Cystoscopic findings of bladder trabeculations, as well as pre and postoperative urinary symptoms were recorded. Patients with and without bladder trabeculations were compared with respect to baseline characteristics, lower urinary tract symptoms, and sling outcomes. RESULTS: Of the 241 women included in the study, 14.9% had trabeculations on preoperative cystoscopy. At baseline, women with trabeculations were more likely to be older (64.8 years versus 57.8 years, p < 0.01), and have lower mean maximum cystometric capacity (341 mL +/- 136 versus 436 mL +/- 148, p < 0.01), compared to those without trabeculations. More women with trabeculations had mixed incontinence (p < 0.01) and less pure stress incontinence (p < 0.01) preoperatively. There was no difference between women with and without trabeculations with respect to pre and postoperative symptoms of urgency, frequency, and nocturia. Women with preoperative trabeculations were more likely to have preoperative treatment with anticholinergics (p = 0.02) and had a three times higher risk of postoperative sling failure (HR 2.95 [CI 1.11-7.85], p = 0.03). CONCLUSIONS: Preoperative cystoscopic bladder trabeculations are associated with significantly higher rate of midurethral sling failure. Trabeculations were not associated with pre or postoperative lower urinary tract symptoms.

Current role of mesh in vaginal prolapse surgery.

PURPOSE OF REVIEW: This report summarizes the latest literature on transvaginal mesh (TVM) for the treatment of pelvic organ prolapse, with a focus on indications for use and management of complications. We describe trends in TVM by reviewing the recent literature and summarizing national meeting presentations. RECENT FINDINGS: Vaginal mesh complications are most often managed surgically, and the majority of patients experiencing mesh-related pain have symptom improvement after intervention. New efforts will focus on identifying variables associated with success after intervention for mesh-related complications, to aid reconstructive pelvic surgeons in outcome prediction and patient counselling. SUMMARY: Although the use of TVM has plateaued in recent years, we are seeing an exponential rise in synthetic mesh implant removal. Reconstructive pelvic surgeons advising patients with TVM complications should report that surgical intervention is often necessary, improvement rates of pain-related symptoms after surgery are high, and up to a third may require multiple interventions.

Hysterectomy and urinary incontinence in postmenopausal women.

INTRODUCTION AND HYPOTHESIS: To evaluate an association between hysterectomy and urinary incontinence (UI) in postmenopausal women. METHODS: Women (aged 50-79) with uteri (N = 53,569) and without uteri (N = 38,524) who enrolled in the Women's Health Initiative (WHI) Observational Study between 1993 and 1996 were included in this secondary analysis. Baseline (BL) and 3-year demographic, health/physical forms and personal habit questionnaires were used. Statistical analyses included univariate and logistic regression methods. RESULTS: The baseline UI rate was 66.5 %, with 27.3 % of participants having stress urinary incontinence (SUI), 23 % having urge UI (UUI), and 12.4 % having mixed UI (MUI). 41.8 % of women had undergone hysterectomy, with 88.1 % having had the procedure before age 54. Controlling for health/physical variables, hysterectomy was associated with UI at BL (OR 1.25, 95 % CI 1.19, 1.32) and over the 3-year study period (OR 1.23, 95 % CI 1.11, 1.36). Excluding women with UI at BL, a higher incidence of UUI and SUI episodes was found in hysterectomy at year 3. Among women who had undergone hysterectomy, those with bilateral oophorectomy (BSO) did not have increased odds of developing UI at BL or over the 3-year study period. Hormone use was not associated with a change in UI incidence (estrogen + progesterone, p = 0.17; unopposed estrogen, p = 0.41). CONCLUSIONS: Risk of UI is increased in postmenopausal women who had undergone hysterectomy compared with women with uteri.

Incidence of unanticipated uterine pathology at the time of minimally invasive abdominal sacrocolpopexy.

STUDY OBJECTIVE: To determine the incidence of unanticipated uterine pathologic findings in women undergoing hysterectomy concomitant with minimally invasive sacrocolpopexy. DESIGN: Retrospective case series (Canadian Task Force classification III). SETTING: Four institutions in the United States. PATIENTS: Women undergoing laparoscopic or robotically assisted sacrocolpopexy with hysterectomy. INTERVENTIONS: Concurrent hysterectomy and minimally invasive sacrocolpopexy. MEASUREMENTS AND MAIN RESULTS: We measured the incidence of clinically important uterine disease at minimally invasive sacrocolpopexy. A total of 324 women underwent concurrent hysterectomy and minimally invasive sacrocolpopexy. Their mean age was 56.1 years, and body mass index was 26.9 kg/m(2). Sixty-four percent were postmenopausal. Only 3 patients (0.92%) had abnormal uterine pathologic findings. No significant differences were noted in age, body mass index, or parity between the women with normal and abnormal uterine pathologic findings. None of the 3 women reported abnormal uterine bleeding before surgery. All lesions were premalignant and focal. No invasive carcinomas were identified. No patients required further follow-up or treatment of abnormal pathologic findings. CONCLUSION: The risk of unanticipated uterine pathologic findings during minimally invasive sacrocolpopexy to treat pelvic organ prolapse is low.

The pelvic floor complication scale: a new instrument for reconstructive pelvic surgery.

OBJECTIVE: The purpose of this study was to develop and test a unique, new pelvic floor surgery complication scale and compare it with an existing validated measure. STUDY DESIGN: Surgeons from 2 clinical trials networks rated complications based on perceived patient bother, severity, and duration of disability to develop a pelvic floor complication scale (PFCS). PFCS scores were calculated for subjects in 2 multicenter pelvic floor surgical trials. The PFCS and modified Clavien-Dindo scores were evaluated for associations with length of hospitalization, satisfaction, and quality-of-life measures (health utilities index, short form-36, urogenital distress inventory, and incontinence impact questionnaire). RESULTS: We calculated PFCS scores for 977 subjects. Higher PFCS and Clavien-Dindo scores similarly were associated with longer length of hospitalization (P < .01), lower satisfaction (P < .01), lower Health Utilities Index scores (P = .02), lower short form-36 scores (P = .02), higher urogenital distress Inventory scores (P < .01), and incontinence impact questionnaire scores (P < .01) at 3 months. No associations were present at 1 year. CONCLUSION: The PFCS compares favorably to the validated modified Clavien-Dindo instrument.

Blinded assessment of operative performance after fundamentals of laparoscopic surgery in gynecology training.

STUDY OBJECTIVE: To determine the pass rate for the Fundamentals of Laparoscopic Surgery (FLS) examination among senior gynecology residents and fellows and to find whether there is an association between FLS scores and previous laparoscopic experience as well as laparoscopic intraoperative (OR) skills assessment. DESIGN: Prospective cohort study (Canadian Task Force classification II-2). SETTING: Three gynecology residency training programs. PARTICIPANTS: Third- and fourth-year gynecology residents and urogynecology fellows. INTERVENTIONS: All participants participated in the FLS curriculum, written and manual skills examination, and completed a survey reporting baseline characteristics and opinions. Fourth-year residents and fellows underwent unblinded and blinded pre- and post-FLS OR assessments. Objective OR assessments of fourth-year residents after FLS were compared with those of fourth-year resident controls who were not FLS trained. MEASUREMENTS AND MAIN RESULTS: Twenty-nine participants were included. The overall pass rate was 76%. The pass rate for third- and fourth-year residents and fellows were 62%, 85%, and 100%, respectively. A trend toward improvement in OR assessments was observed for fourth-year residents and fellows for pre-FLS curriculum compared with post-FLS testing, and FLS-trained fourth-year residents compared with fourth-year resident controls; however, this did not reach statistical significance. Self-report of laparoscopic case load experience of >20 cases was the only baseline factor significantly associated with passing the FLS examination (p = .03). CONCLUSION: The FLS pass rate for senior residents and fellows was 76%, with higher pass rates associated with increasing levels of training and laparoscopic case experience.

Sacrospinous Fixation and Vaginal Uterosacral Suspension-Evaluation in Uterine Preservation Surgery.

IMPORTANCE: Vaginal hysteropexy can be performed via the uterosacral or the sacrospinous ligament(s), but little data exist comparing these routes. OBJECTIVE: The aim of the study was to compare prolapse recurrence, retreatment, and symptoms along with the incidence of adverse events between patients undergoing vaginal uterosacral hysteropexy and sacrospinous hysteropexy. STUDY DESIGN: This was a multicenter retrospective cohort study of patients who underwent vaginal uterosacral or sacrospinous hysteropexy (SSHP) between 2015 and 2019. Anatomic failure was the primary outcome, defined as prolapse beyond the hymen. Composite failure was defined as anatomic failure, bulge symptoms, and/or retreatment for prolapse. RESULTS: At 4 geographically diverse referral centers, 147 patients underwent SSHP and 114 underwent uterosacral hysteropexy. The 1-year follow-up rate was 32% (83/261) with no difference between groups. There were 10 (3.8%) anatomic failures: 3 (2%) sacrospinous and 7 (6.1%) uterosacral ( P = 0.109). There was no difference in bulge symptoms (9.9%), composite failure (13%), or median prolapse stage (2).The overall incidence of complications was low (7%; 95% confidence interval, 4.12%-10.43%) with a higher rate of ureteral kinking in the uterosacral group (7% vs 1.4%, P = 0.023). With a median follow-up of 17 months, 4.6% underwent subsequent hysterectomy and 6.5% had treatment for uterine/cervical pathology. CONCLUSIONS: One year after hysteropexy, 1 in 3 patients were available for follow-up, and there were no differences in prolapse recurrence between patients who underwent uterosacral hysteropexy versus SSHP. The incidence of adverse events was low, and less than 5% of patients underwent subsequent hysterectomy for prolapse.