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.

Twelve Month Outcomes of Pelvic Organ Prolapse Surgery in Patients With Uterovaginal or Posthysterectomy Vaginal Prolapse Enrolled in the Multicenter Pelvic Floor Disorders Registry.

OBJECTIVE: The aim of the study was to compare 12-month subjective and objective outcomes between 3 approaches to apical pelvic organ prolapse (POP) surgery in patients presenting with uterovaginal or posthysterectomy vaginal prolapse enrolled in the Pelvic Floor Disorders Registry for Research. STUDY DESIGN: This was an analysis of a multicenter, prospective registry that collected both patient- and physician-reported data for up to 3 years after conservative (pessary) and surgical treatment for POP. Twelve-month subjective and anatomic outcomes for patients who underwent surgical treatment were extracted from the registry for analysis. Pelvic organ prolapse recurrence was defined as a composite outcome and compared between the 3 apical surgery groups (native tissue repair, sacrocolpopexy, colpocleisis) as well as the 2 reconstructive surgery groups (native tissue repair and sacrocolpopexy). RESULTS: A total of 1,153 women were enrolled in the registry and 777 (67%) opted for surgical treatment, of whom 641 underwent apical repair and were included in this analysis (404 native tissue repair, 187 sacrocolpopexy, and 50 colpocleisis). The overall incidence of recurrence was as follows: subjective 6.5%, anatomic 4.7%, retreatment 7.2%, and composite 13.6%. The incidence of recurrence was not different between the 3 surgical groups. When baseline patient characteristics were controlled for, composite POP recurrence between the native tissue and sacrocolpopexy groups remained statistically nonsignificant. Concurrent perineorrhaphy with any type of apical POP surgery was associated with a lower risk of recurrence (adjusted odds ratio, 0.43; 95% confidence interval, 0.25-0.74; P = 0.002) and prior hysterectomy was associated with a higher risk (adjusted odds ratio, 1.77, 95% confidence interval, 1.04-3.03; P = 0.036). CONCLUSION: Pelvic Floor Disorders Registry for Research participants undergoing native tissue apical POP repair, sacrocolpopexy, and colpocleisis surgery had similar rates of POP recurrence 12 months after surgery.

STOMp: sexual function trial of overactive bladder medication.

Background: Female sexual function has been shown to improve with overactive bladder (OAB) treatment. Aim: The objective of this study was to evaluate the effects of anticholinergics (ACHs) or a beta-agonist (BAG) on female sexual function. Methods: This was a prospective multicenter cohort study. Sexually active women with OAB completed the Overactive Bladder questionnaire (OAB-q) and Female Sexual Function Index (FSFI) prior to and after 12 weeks of therapy. Sample sizes of 63 per group were calculated to detect a clinically relevant difference in the FSFI. Outcomes: The primary outcome was FSFI change from baseline at 12 weeks. Results: A total of 157 patients were recruited, and 91 completed follow-up (58/108, ACH; 31/49, BAG). There were within-group FSFI differences from pre- to posttreatment: a worsening of arousal in the ACH group (P = .046) and an improvement in overall FSFI (P = .04) and pain (P = .04) in the BAG group. After treatment, postmenopausal women in the BAG group had significantly better overall FSFI (P = .01), desire (P = .003), arousal (P = .009), and orgasm (P = .01). Clinical Implications: While further research is necessary, this study provides information about the comparative effects of OAB treatments on female sexual function, which may ultimately lead to better patient selection and outcomes. Strengths and Limitations: While there was no difference between the subjects who completed the study and those who did not, the study remained underpowered after the loss to follow-up. The multicenter cohort design allows for generalizability of results. Conclusion: Although this study was underpowered, an improvement in overall sexual function was seen with BAGs, while ACHs were associated with worsening aspects of sexual function.

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.

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.

Outcomes of Pessary Use at 1 Year in Women Treated for Pelvic Organ Prolapse in a Large Multicenter Registry: Developed by the Pelvic Floor Disorders Registry.

IMPORTANCE: There is a lack of high-quality long-term follow-up regarding pessary treatment. Most studies are case series or retrospective with a small sample size and short-term follow-up. OBJECTIVES: This study aimed to evaluate differences in women who continue versus discontinue pessary use and the effectiveness, quality of life, and safety associated with pessary management at 1 year. STUDY DESIGN: This study analyzed a multicenter national registry following women for 3 years with vaginal prolapse treated with a pessary or surgery. The primary outcome of this analysis was to compare the difference in characteristics among those who continue versus discontinue pessary use at 12 months. RESULTS: Among 1,153 participants enrolled, 376 (32.6%) opted for a pessary, and 296 (78.7%) were successfully fitted. Data were available for 240 participants (81%). At 1 year, 62% (n = 148) were still using pessaries, and 38% (n = 92) had stopped with 25% opting for surgery. Most commonly reported de novo adverse effects were urinary leakage (16%), feeling or seeing a bulge (12%), and vaginal discharge (11%). There was no difference in baseline characteristics among women who continued versus discontinued pessary use. At 12 months, subjective symptoms were similar between groups, with similar change in symptoms from baseline on most validated instruments. Those who continued to use a pessary reported worse urinary symptoms due to de novo urinary leakage ( P = 0.01). CONCLUSIONS: At 1 year, most women successfully fitted with a pessary continued pessary use. Although there was a significant improvement in condition-specific quality of life and low rates of complications, approximately 40% of women discontinued pessary use by 12 months. We were unable to identify any baseline characteristics associated with pessary discontinuation.

Length of Stay and 30-Day Postoperative Complications Following Minimally Invasive Apical Prolapse Repair.

IMPORTANCE: Data on the correlation between length of stay and postoperative complications following urogynecologic surgery are limited. OBJECTIVES: The objective of this study was to use a nationwide database to examine the correlation between length of stay and 30-day postoperative complications following minimally invasive apical prolapse repair. STUDY DESIGN: This retrospective cohort study included women in the American College of Surgeons National Surgical Quality Improvement Program database from 2008 to 2018 who underwent laparoscopic/robotic sacrocolpopexy or uterosacral/sacrospinous repair and were discharged on postoperative day 0 (POD0) or 1 (POD1). The primary outcome was 30-day postoperative complication rate. RESULTS: Of the 28,269 women discharged home on POD0/1, 12,663 (45%) underwent laparoscopic/robotic sacrocolpopexy, and 15,606 (55%) underwent uterosacral/sacrospinous repair. Women discharged on POD0 were less likely to be White, less likely to have diabetes or hypertension, had lower mean body mass index, and were less likely to have undergone a hysterectomy ( P < 0.05 for all). Within 30 days of surgery, 7% had a postoperative complication, and 3% had a major complication. Women discharged on POD0 had a lower risk of any complication or any major complication. The most common complication, urinary tract infection, was lower in women discharged on POD0 (3% vs 4%, P < 0.01). Women discharged home on the same day had a higher risk of superficial surgical site infection after undergoing laparoscopic/robotic sacrocolpopexy (1.3% vs 0.5%, P < 0.01) and a higher risk of myocardial infarction/cardiac arrest after uterosacral/sacrospinous repair (0.2% vs 0%, P < 0.04). CONCLUSIONS: In women undergoing minimally invasive reconstructive apical repair, discharge on POD0 is correlated with similar or better (lower) 30-day postoperative complication rates compared with women discharged on POD1.

Long-Term Outcomes After Vaginal and Laparoscopic Mesh Hysteropexy for Uterovaginal Prolapse: A Parallel Cohort Study (eVAULT).

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.

Success of Concomitant Versus Interval Slings for Prevention and Treatment of Bothersome de Novo Stress Urinary Incontinence.

BACKGROUND: Despite large trials designed to guide management on whether to perform a prophylactic continence procedure at the time of pelvic organ prolapse (POP) repair, it remains unclear if a staged or interval approach confers advantages in treatment of bothersome stress urinary incontinence (SUI) in women without bothersome SUI before their POP repair. OBJECTIVE: The objective of this study was to compare success of concomitant versus interval slings for the prevention/treatment of de novo bothersome SUI after POP repair. STUDY DESIGN: This multicenter retrospective cohort with prospective follow-up enrolled women with minimal or no SUI symptoms who underwent minimally invasive apical surgery for stage 2 or higher POP between 2011 and 2018 and had a concomitant sling placed at the time of POP surgery or an interval sling placed. Prospectively, all patients were administered the Urogenital Distress Inventory Short-Form 6, the Patient Global Impression of Improvement, and questions on reoperation/retreatment and complications. RESULTS: A total of 120 patients had concomitant slings, and 60 had interval slings. There were no differences in the proportion of patients who had intrinsic sphincter deficiency (22% vs 20%), although the concomitant sling group was more likely to have a positive cough stress test result (30% vs 8%, P = 0.006). The interval sling group was more likely to report "yes" to SUI symptoms on Urogenital Distress Inventory Short-Form 6 (3% vs 30%, P = 0.0006) and during their postoperative visit (0% vs 24%, P < 0.0001). There were no differences in surgical complications. CONCLUSIONS: Among women with minimal or no SUI symptoms undergoing prolapse repair, concomitant slings resulted in lower rates of bothersome SUI compared with similar women undergoing interval sling placement.

Postoperative Urinary Incontinence in Diabetic Patients Undergoing Pelvic Reconstructive Surgery.

IMPORTANCE: Diabetes is an independent risk factor for urinary incontinence, and its impact on rates of postoperative incontinence after pelvic reconstructive surgery remains unexplored. OBJECTIVE: The aim of the study was to compare the incidence of postoperative stress urinary incontinence (SUI), urgency urinary incontinence (UUI), and mixed urinary incontinence in patients with diabetes mellitus undergoing surgery for pelvic organ prolapse (POP) with or without SUI surgery. STUDY DESIGN: This is a secondary analysis of a multicenter retrospective cohort study involving 10 diverse medical centers that identified a cohort of women with diabetes who had prolapse and/or anti-incontinence surgery. We compared rates of postoperative urinary incontinence among patients who had surgery for prolapse and incontinence versus surgery for prolapse only. RESULTS: Three hundred five patients had surgery for prolapse and incontinence, 330 had surgery for prolapse only, and 189 had anti-incontinence surgery only. De novo UUI was higher among those who underwent surgery for POP and SUI compared with surgery for POP alone (26.4% vs 14.1%, P < 0.01). Rates of persistent SUI (21% vs 4.9%, P < 0.01) and mixed urinary incontinence (15.9% vs 2.7%, P < 0.01) were higher for those who underwent prolapse surgery alone versus prolapse and an incontinence procedure. No differences were seen in hemoglobin A1C levels between those who did and did not report postoperative UI. CONCLUSIONS: We found that postoperative de novo UUI rates were high among patients with diabetes after pelvic reconstructive surgery, with the incidence being significantly higher for those who had surgery for prolapse and incontinence compared with surgery for prolapse only.

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.

Surgical Outcomes in Urogynecology-Assessment of Perioperative and Postoperative Complications Relative to Preoperative Hemoglobin A1c-A Fellows Pelvic Research Network Study.

OBJECTIVES: Poor control of diabetes mellitus is a known predictor of perioperative and postoperative complications. No literature to date has established a hemoglobin A1c (HbA1c) cutoff for risk stratification in the urogynecology population. We sought to identify an HbA1c threshold predictive of increased risk for perioperative and postoperative complications after pelvic reconstructive surgery. METHODS: This multicenter retrospective cohort study involving 10 geographically diverse U.S. female pelvic medicine and reconstructive surgery programs identified women with diabetes who underwent prolapse and/or stress urinary incontinence surgery from September 1, 2013, to August 31, 2018. We collected information on demographics, preoperative HbA1c levels, surgery type, complications, and outcomes. Sensitivity analyses identified thresholds of complications stratified by HbA1c. Multivariate logistic regression further evaluated the association between HbA1c and complications after adjustments. RESULTS: Eight hundred seven charts were identified. In this diabetic cohort, the rate of overall complications was 44.1%, and severe complications were 14.9%. Patients with an am HbA1c value of 8% or greater (reference HbA1c, <8%) had an increased rate of both severe (27.1% vs 12.8%, P < 0.001) and overall complications (57.6% vs 41.8%, P = 0.002) that persisted after multivariate logistic regression (odds ratio, 2.618; 95% confidence interval, 1.560-4.393 and odds ratio, 1.931; 95% confidence interval, 1.264-2.949, respectively). Mesh complications occurred in 4.6% of sacrocolpopexies and 1.7% of slings. The average HbA1c in those with mesh exposures was 7.5%. CONCLUSIONS: Preoperative HbA1c of 8% or higher was associated with a 2- to 3-fold increased risk of overall and severe complications in diabetic patients undergoing pelvic reconstructive surgery that persisted after adjustments.

Development of a Simplified Patient-Centered Pelvic Floor Surgery Complication Scale.

OBJECTIVES: There does not currently exist a complication scale to evaluate pelvic reconstructive surgery (PRS) that takes in account patient-centered outcomes. The purpose of this study was to characterize and compare patient and surgeon responses to a simplified, patient-centered version of the previously described Pelvic Floor Complication Scale (PFCS). METHODS: This is a multicenter (4 female pelvic medicine and reconstructive surgery practices) cross-sectional study of patients and surgeons. Using focus groups and telephone surveys, the original PFCS questionnaire was simplified. One hundred and twenty-four patients were recruited 6-12 months after PRS. Fifty-seven surgeons were recruited via electronic questionnaires. Surgeons and patients were asked to rank the severity and bother of each complication on a scale of 0 to 5 (0, none; 1, mild; 3, moderate; 5, major). RESULTS: Patients rated bother higher than severity for 36 of 38 complications (all differences ≤0.5 points). For statistical analysis, the highest response to patient bother/severity was chosen to weigh in favor of the patient. Patient bother/severity scores were significantly different (±0.5 points) for 27 of 38 complications compared with surgeon responses. Surgeon scores were higher for 5 complications (0.5-1.9 point differences) related to major injury requiring repair and wound breakdown. Patient scores were higher for 22 complications with the highest differences related to dyspareunia, constipation, or new/persistent urinary incontinence. CONCLUSIONS: This mixed methods investigation revealed key differences between how patients and surgeons value PRS complications. Surgeons scored major surgical injuries higher than patients, whereas patients rated issues that many surgeons consider quality-of-life outcomes higher due to potential long-term bother. These data will be used to create a simplified, patient-centered PFCS.

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.

Generic Health-Related Quality of Life in Patients Seeking Care for Pelvic Organ Prolapse.

OBJECTIVE: Using the American Urogynecologic Society multicenter Pelvic Floor Disorder Registry for Research, we (1) compared generic quality of life (QOL) in women planning pelvic organ prolapse (POP) treatment (surgery vs pessary), (2) correlated generic and condition-specific QOL scores, and (3) identified associations between generic QOL and other factors. METHODS: This cross-sectional analysis assessed generic physical and mental QOL using the Patient-Reported Outcomes Measurement Information System Global Health Scale at baseline. Global Physical and Mental T-scores center on a representative US population sample (mean [SD], 50 [10]; higher scores, better health). Condition-specific QOL was assessed with Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and POP/Urinary Incontinence Sexual Function Questionnaire. Linear regression models identified associations between clinical factors and Global Physical/Mental scores. RESULTS: Five hundred sixty-eight women (419 surgery, 149 pessary) were included. Surgery patients were younger, heavier, and more often sexually active (all P's ≤ 0.01). Global Physical scores were lower in the surgery versus pessary group, but not likely clinically meaningful (mean [SD], 48.8 [8.1] vs 50.4 [8.5]; P = 0.035); Global Mental scores were similar (51.4 [8.4] vs 51.9 [9.5], P = 0.56). Global Health scores correlated with Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and POP/Urinary Incontinence Sexual Function Questionnaire scores (all P's < 0.0001). In multivariable models, menopause was associated with better physical QOL, and constipation, coronary artery disease, pelvic pain, and increased body mass index with worse physical QOL. Age was associated with better mental QOL, and constipation, fecal incontinence, pelvic pain, and coronary artery disease with worse mental QOL. CONCLUSIONS: Women choosing POP surgery versus pessary had similar physical and mental generic QOL.

Clobetasol Compared With Fractionated Carbon Dioxide Laser for Lichen Sclerosus: A Randomized Controlled Trial.

OBJECTIVE: To compare 6-month safety and efficacy outcomes of fractionated CO2 laser (laser) with topical clobetasol propionate (steroid) for treatment of symptomatic vulvar lichen sclerosus. METHODS: We conducted a single-center randomized controlled trial that compared fractionated CO2 laser with steroid treatment for patients with biopsy-proven lichen sclerosus. Randomization was stratified by prior clobetasol propionate use. The primary outcome was mean change in Skindex-29 score at 6 months. A total sample size of 52 participants were recruited to detect a mean difference of 16 points on the Skindex-29 (SD±22) with 80% power, based on a one-sided two-sample t test with α=0.05, accounting for 10% attrition. Secondary outcomes included validated subjective and objective measures. Intention-to-treat, per protocol, and regression analysis based on prior steroid exposure were performed. RESULTS: From October 2015 to July 2018, 202 women were screened, 52 were randomized, and 51 completed a 6-month follow-up. No significant difference was found in baseline demographics, symptoms, and physician assessment scores. There was greater improvement in the Skindex-29 score in the laser arm at 6-months (10.9 point effect size, 95% CI 3.42-18.41; P=.007). Overall, 89% (23/27) of patients in the laser group rated symptoms as being "better or much better" compared with 62% (13/24) of patients in the steroid group, P=.07. More patients (81%, 21/27) were "satisfied or very satisfied" with laser treatment compared with steroid treatment (41%, 9/24); P=.01. After stratification for previous steroid use, the significant change of Skindex-29 score was only seen in the previously exposed group. There was one adverse event in each group: minor burning and blistering at the laser site and reactivation of genital herpes 1 week after starting steroid. CONCLUSION: Fractionated CO2 laser treatment showed significant improvement in subjective symptoms and objective measures compared with clobetasol propionate, without serious safety or adverse events at 6 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02573883.

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.

Summary: 2017 International Consultation on Incontinence Evidence-Based Surgical Pathway for Pelvic Organ Prolapse.

OBJECTIVE: The aim of this article is to summarize the relevant findings that inform the 2017 International Consultation on Incontinence pathway for surgical treatment of pelvic organ prolapse (POP). METHODS: We conducted an evidence-based review of the English-language peer-reviewed literature relating to POP surgery published prior to December 2016. Level 1 evidence (randomized controlled trials [RCTs] or systematic reviews of RCTs) was preferred; however, level 2 (poor-quality RCT, prospective cohort studies) or 3 evidence (case series or retrospective studies) has been included if level 1 data were lacking. The committee evaluated the literature and made recommendations based on the Oxford grading system summarized as follows: grade A recommendation usually depends on consistent level 1 evidence; grade B recommendation usually depends on consistent level 2 and/or 3 studies, or "majority evidence" from RCTs; grade C recommendation usually depends on level 3 studies or "majority evidence" from level 2/3 studies or Delphi-processed expert opinion; grade D, "no recommendation possible," would be used where the evidence is inadequate or conflicting. RESULTS: The recommendations from each chapter of the review are presented and serve to inform an evidence-based pathway for the surgical treatment of prolapse. A Web-based interactive application of the pathway is presented. CONCLUSIONS: The 2017 International Consultation on Incontinence pathway on surgery for POP is designed as an adjunct to transparent consultation and consent relating to POP surgery. The final decision regarding surgical intervention can be made only after a shared decision-making process between the patient and the clinician that will evaluate a variety of individual factors that cannot be assessed in the pathway.