Apical Suspension Repair for Vaginal Vault Prolapse: A Randomized Clinical Trial.

Importance: The optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined. Objective: To compare the efficacy and safety of 3 surgical approaches for vaginal vault prolapse after hysterectomy. Design, Setting, and Participants: This was a multisite, 3-arm, superiority and noninferiority randomized clinical trial. Outcomes were assessed biannually up to 60 months, until the last participant reached 36 months of follow-up. Settings included 9 clinical sites in the US National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. Between February 2016 and April 2019, women with symptomatic vaginal vault prolapse after hysterectomy who desired surgical correction were randomized. Data were analyzed from November 2022 to January 2023. Interventions: Mesh-augmented (either abdominally [sacrocolpopexy] or through a vaginal incision [transvaginal mesh]) vs transvaginal native tissue repair. Main Outcomes and Measures: The primary outcome was time until composite treatment failure (including retreatment for prolapse, prolapse beyond the hymen, or prolapse symptoms) evaluated with survival models. Secondary outcomes included patient-reported symptom-specific results, objective measures, and adverse events. Results: Of 376 randomized participants (mean [SD] age, 66.1 [8.7] years), 360 (96%) had surgery, and 296 (82%) completed follow-up. Adjusted 36-month failure incidence was 28% (95% CI, 20%-37%) for sacrocolpopexy, 29% (95% CI, 21%-38%) for transvaginal mesh, and 43% (95% CI, 35%-53%) for native tissue repair. Sacrocolpopexy was found to be superior to native tissue repair (adjusted hazard ratio [aHR], 0.57; 99% CI, 0.33-0.98; P = .01). Transvaginal mesh was not statistically superior to native tissue after adjustment for multiple comparisons (aHR, 0.60; 99% CI, 0.34-1.03; P = .02) but was noninferior to sacrocolpopexy (aHR, 1.05; 97% CI, 0-1.65; P = .01). All 3 surgeries resulted in sustained benefits in subjective outcomes. Mesh exposure rates were low (4 of 120 [3%] for sacrocolpopexy and 6 of 115 [5%] for transvaginal mesh) as were the rates of dyspareunia. Conclusions and Relevance: Among participants undergoing apical repair for vaginal vault prolapse, sacrocolpopexy and transvaginal mesh resulted in similar composite failure rates at study completion; both had lower failure rates than native tissue repair, although only sacrocolpopexy met a statistically significant difference. Low rates of mesh complications and adverse events corroborated the overall safety of each approach. Trial Registration: ClinicalTrials.gov Identifier: NCT02676973.

Trial Design for Mixed Urinary Incontinence: Midurethral Sling Versus Botulinum Toxin A.

IMPORTANCE: Mixed urinary incontinence (MUI) is common and can be challenging to manage. OBJECTIVES: We present the protocol design and rationale of a trial comparing the efficacy of 2 procedures for the treatment of women with MUI refractory to oral treatment. The Midurethral sling versus Botulinum toxin A ( MUSA) trial compares the efficacy of intradetrusor injection of 100 U of onabotulinimtoxinA (an office-based procedure directed at the urgency component) versus midurethral sling (MUS) placement (a surgical procedure directed at the stress component). STUDY DESIGN: The MUSA is a multicenter, randomized trial of women with MUI electing to undergo procedural treatment for MUI at 7 clinical centers in the NICHD Pelvic Floor Disorders Network. Participants are randomized to either onabotulinumtoxinA 100 U or MUS. OnabotulinimtoxinA recipients may receive an additional injection between 3 and 6 months. Participants may receive additional treatment (including crossover to the alternative study intervention) between 6 and 12 months. The primary outcome is change from baseline in Urogenital Distress Inventory (UDI) at 6 months. Secondary outcomes include change in UDI at 3 and 12 months, irritative and stress subscores of the UDI, urinary incontinence episodes, predictors of poor treatment response, quality of life and global impression outcomes, adverse events, use of additional treatments, and cost effectiveness. RESULTS: Recruitment and randomization of 150 participants is complete and participants are currently in the follow-up phase. CONCLUSIONS: This trial will provide information to guide care for women with MUI refractory to oral treatment who seek surgical treatment with either onabotulinumtoxinA or MUS.

Proregenerative extracellular matrix hydrogel mitigates pathological alterations of pelvic skeletal muscles after birth injury.

Pelvic floor disorders, including pelvic organ prolapse and urinary and fecal incontinence, affect millions of women globally and represent a major public health concern. Pelvic floor muscle (PFM) dysfunction has been identified as one of the leading risk factors for the development of these morbid conditions. Childbirth, specifically vaginal delivery, has been recognized as the most important potentially modifiable risk factor for PFM injury; however, the precise mechanisms of PFM dysfunction after parturition remain elusive. In this study, we demonstrated that PFMs exhibit atrophy and fibrosis in parous women with symptomatic pelvic organ prolapse. These pathological alterations were recapitulated in a preclinical rat model of simulated birth injury (SBI). The transcriptional signature of PFMs after injury demonstrated an impairment in muscle anabolism, persistent expression of genes that promote extracellular matrix (ECM) deposition, and a sustained inflammatory response. We also evaluated the administration of acellular injectable skeletal muscle ECM hydrogel for the prevention of these pathological alterations. Treatment of PFMs with the ECM hydrogel either at the time of birth injury or 4 weeks after injury mitigated PFM atrophy and fibrosis. By evaluating gene expression, we demonstrated that these changes are mainly driven by the hydrogel-induced enhancement of endogenous myogenesis, ECM remodeling, and modulation of the immune response. This work furthers our understanding of PFM birth injury and demonstrates proof of concept for future investigations of proregenerative biomaterial approaches for the treatment of injured pelvic soft tissues.

Efficacy of vaginal estrogen for recurrent urinary tract infection prevention in hypoestrogenic women.

BACKGROUND: Vaginal estrogen is considered to be the standard of care for recurrent urinary tract infection prevention in women with hypoestrogenism. However, literature supporting its use is limited to small clinical trials with narrow generalizability. OBJECTIVE: This study aimed to assess the association between vaginal estrogen prescription and the frequency of urinary tract infections over the following year in a diverse population of women with hypoestrogenism. Secondary objectives included evaluation of medication adherence and predictors of postprescription urinary tract infection. STUDY DESIGN: This multicenter retrospective review included women who were prescribed vaginal estrogen for the indication of recurrent urinary tract infection from January 2009 through December 2019. Recurrent urinary tract infection was defined as having ≥3 positive urine cultures (separated by at least 14 days) in the 12 months preceding the index vaginal estrogen prescription. Patients were asked to fill their prescriptions and continue care within Kaiser Permanente Southern California system for at least 1 year. Exclusion criteria included anatomic abnormalities, malignancy, or mesh erosion of the genitourinary tract. Data on demographics, medical comorbidities, and surgical history were collected. Adherence was captured through refill data after the index prescription. Low adherence was defined as no refills; moderate adherence was defined as 1 refill; high adherence was defined as ≥2 refills. Data were abstracted from the electronic medical record system using the pharmacy database and diagnosis codes. A paired t test was used to compare pre- and postprescription urinary tract infections over the year preceding and following the vaginal estrogen prescription. A multivariate negative binomial regression was used to evaluate predictors of postprescription urinary tract infection. RESULTS: The cohort included 5638 women with a mean (±standard deviation) age of 70.4 (±11.9) years, body mass index of 28.5 (±6.3) kg/m2, and baseline urinary tract infection frequency of 3.9 (±1.3). Most of the participants were White (59.9%) or Hispanic (29.7%) and postmenopausal (93.4%). The mean urinary tract infection frequency in the year following the index prescription decreased to 1.8 (P<.001) from 3.9 in the year preceding the prescription, which is a 51.9% reduction. During the 12 months after the index prescription, 55.3% of patients experienced ≤1 urinary tract infections, and 31.4% experienced no urinary tract infections. Significant predictors of postprescription urinary tract infection included age of 75 to 84 years (incident rate ratio, 1.24; 95% confidence interval, 1.05-1.46) and >85 years (1.41; 1.17-1.68), increased baseline urinary tract infection frequency (1.22; 1.19-1.24), urinary incontinence (1.14; 1.07-1.21), urinary retention (1.21; 1.10-1.33), diabetes mellitus (1.14; 1.07-1.21), and moderate (1.32; 1.23-1.42) or high medication adherence (1.33; 1.24-1.42). Patients with high medication adherence demonstrated more frequent postprescription urinary tract infections than patients with low adherence (2.2 vs 1.6; P<.0001). CONCLUSION: In this retrospective review of 5600 women with hypoestrogenism who were prescribed vaginal estrogen for the prevention of recurrent urinary tract infections, the frequency of urinary tract infection decreased by more than 50% in the following year. Baseline urinary tract infection frequency, increasing age, urinary incontinence or retention, and diabetes were associated with an increased risk of postprescription urinary tract infection. The paradoxical finding that women with moderate and high medication adherence experienced the lowest-magnitude reduction in urinary tract infection frequency may represent unobserved selection or unmeasured confounding.

Urinary Tract Infections After Urogynecologic Surgery: Risk Factors, Timeline, and Uropathogens.

IMPORTANCE: Urinary tract infection (UTI) is a common and potentially avoidable postoperative (PO) adverse event after urogynecologic surgery. Understanding pathophysiology will help prevent the associated morbidity of the disease and treatment of PO-UTI. OBJECTIVE: The objective of this study is to determine the following: (1) risk factors for both PO-UTI and PO recurrent UTI (RUTI) after urogynecologic surgery, (2) temporal distribution of UTI, and (3) uropathogen identification. STUDY DESIGN: Women undergoing urogynecologic surgery were retrospectively reviewed. Urinary tract infection was defined by culture or antibiotic prescription for symptoms. Recurrent UTI was defined as occurring outside a 6-week perioperative period. The χ 2 test or Fischer exact and Student t tests or Mann-Whitney U test were used as appropriate. Individual odds ratio (OR), 95% confidence interval [CI], and sequential multivariable logistic regression were calculated. Statistical significance was set at P < 0.05. RESULTS: The 6-week PO-UTI rate after 33,626 procedures was 12.9%. Recurrent UTI increased from 3.7% preoperatively to 4.4% postoperatively ( P < 0.001). A 6-week preoperative UTI and RUTI increased the risk of 6-week PO-UTI (OR, 1.65; 95% CI < 1.26-2.16; P = 0.001 and OR, 2.19; 95% CI, 1.84-2.62; P < 0.001, respectively) and PO-RUTI (OR, 2.95; 95% CI, 2.11-4.11; P < 0.001 and OR, 6.79; 95% CI, 5.61-8.23; P < 0.001, respectively). Compared with pelvic organ prolapse (POP) surgery only, stress urinary incontinence (SUI) surgery (OR 1.57[1.30-1.89]), and combined POP/SUI surgery (OR, 1.36; 95% CI, 1.13-1.63]) increased the risk of PO-RUTI ( P < 0.001). Urinary tract infection within 1 week preoperatively was protective against 6-week PO-UTI (OR, 0.68; 95% CI, 0.48-0.97; P = 0.035). No perioperative factors were protective of PO-RUTI. CONCLUSIONS: The PO-RUTI rate in the first year after urogynecologic surgery is low; however, SUI procedures may increase PO-RUTI risk. Potentially, modifiable risk factors for both PO-UTI and PO-RUTI include UTI diagnosis within 6 weeks preoperatively or preoperative RUTI diagnosis. Retesting women the week before surgery to ensure adequate treatment of preoperative UTI may reduce 6-week PO-UTI.

Long-term reoperation risk after apical prolapse repair in female pelvic reconstructive surgery.

BACKGROUND: Although several different apical suspension procedures are available to women with pelvic organ prolapse, data on long-term efficacy and safety profiles are limited. OBJECTIVE: The primary aim of this study was to analyze longitudinal reoperation risk for recurrent prolapse among the 4 apical suspension procedures over 2 to 15 years. Secondary aims included evaluation of all-cause reoperation, defined as a repeated surgery for the indications of recurrent prolapse and adverse events, and total retreatment rate, which included a repeated treatment with another surgery or a pessary. STUDY DESIGN: This was a multicenter, retrospective cohort study within Kaiser Permanente Southern California that included women who underwent sacrocolpopexy, uterosacral ligament suspension, sacrospinous ligament fixation, or colpocleisis from January 2006 through December 2018. Women who underwent concomitant rectal prolapse repair or vaginal prolapse repair with mesh augmentation were excluded. Data were abstracted using procedural and diagnostic codes through July 2021, with manual review of 10% of each variable. Patient demographics and pessary use were compared using analysis of variance or chi square tests for continuous and categorical variables, respectively. Time-to-event analysis was used to contrast reoperation rates. A Cox regression model was used to perform an adjusted multivariate analysis of the following predictors of reoperation for recurrence: index surgery, concomitant procedures, patient demographics, baseline comorbidities, and year of index surgery. Censoring events included exit from the health maintenance organization and death. RESULTS: The cohort included 9681 women with maximum follow-up of 14.8 years. The overall incidence of reoperation for recurrent prolapse was 7.4 reoperations per 1000 patient-years, which differed significantly by type of apical suspension (P<.0001). The incidence of reoperation was lower after colpocleisis (1.4 events per 1000 patient-years) and sacrocolpopexy (4.8 events per 1000 patient-years) when compared with uterosacral ligament suspension (9 events per 1000 patient-years) and sacrospinous ligament fixation (13.9 events per 1000 patient-years). All pairwise comparisons between procedures were significant (P=.0003-.0018) after correction for multiplicity, except for uterosacral ligament suspension or uterosacral ligament hysteropexy vs sacrospinous ligament fixation or sacrospinous ligament hysteropexy (P=.05). The index procedure was the only significant predictor of reoperation for recurrence (P=.0003-.0024) on multivariate regression analysis. Reoperations for complications or sequelae (overall 2.9 events per 1000 patient-years) also differed by index procedure (P<.0001) and were highest after sacrocolpopexy (4.4 events per 1000 patient-years). The incidence of all-cause reoperation for recurrence and adverse events after sacrocolpopexy, however, was comparable to that of the other reconstructive procedures (P=.1-.4) in pairwise comparisons with Bonferroni correction. Similarly, frequency of pessary use differed by index procedure (P<.0001) and was highest after sacrospinous ligament fixation at 9.3% (43/464). CONCLUSION: Among nearly 10,000 patients undergoing prolapse surgery within a large managed care organization, colpocleisis and sacrocolpopexy offered the most durable obliterative and reconstructive prolapse repairs, respectively. All-cause reoperation rates were lowest after colpocleisis by a large margin, but similar among reconstructive apical suspension procedures.

The impact of midurethral sling surgery on the development of urinary tract infections.

PURPOSE/OBJECTIVE: To measure the impact of the placement of a midurethral sling (MUS) on development of urinary tract infections (UTI) in women with stress urinary incontinence. METHODS: This is an analysis of a large managed care organization MUS database from 2005 to 2016. The database was queried to identify UTI and diagnosis of recurrent UTI. The primary outcome was the UTI rate after MUS. Secondary outcomes included the recurrent UTI rate and rates of UTI over time. RESULTS: Over the study period, 13,404 MUS were performed. In the 12 postoperative months, 23% of patients developed a UTI, while 4% developed a de novo recurrent UTI diagnosis. UTIs were most frequently diagnosed in the 1st month, with the 7th postoperative day the most common. Predictors of UTI development included increased age (OR 3.69 [95% CI 2.58-5.26]), being diabetic (OR 1.43 [95% CI 1.28-1.60]), and having urinary retention requiring prolonged catheterization (OR 2.45 [95% CI 2.11-2.85]). UTIs were less likely to be diagnosed in those with transobturator MUS (OR 0.85 [95% CI 0.78-0.94]). Patients who developed a UTI were more likely to have a reoperation (p = 0.0147), including a reoperation for mesh revision/removal (p = 0.0287), and recurrent SUI (p = 0.0394). Patients who developed a UTI were more likely to develop postoperative de novo urgency urinary incontinence (UUI) (p < 0.0001). CONCLUSION: Patients are at risk of UTI and rUTI after MUS. Risk of developing UTIs decreases with time. Predictors of developing UTI can help surgeons in the care of patients after MUS.

Readmission and emergency department visits after minimally invasive sacrocolpopexy and vaginal apical pelvic organ prolapse surgery.

BACKGROUND: Minimally invasive pelvic reconstructive surgery is becoming increasingly common; however, data on readmission and emergency department visits within 30 days of surgery are limited. OBJECTIVE: Our objective was to report the risk factors for 30-day readmission and emergency department visits after minimally invasive pelvic organ prolapse surgery. STUDY DESIGN: This retrospective cohort study included all minimally invasive urogynecologic prolapse procedures with and without concomitant hysterectomy performed within a large managed healthcare organization of 4.5 million members from 2008 to 2018. We queried the system-wide medical record for current procedural terminology and International Classification of Diseases, Ninth or Tenth Revision codes for all included procedures and patient demographic and perioperative data. Our primary outcome was 30-day hospital readmission, and our secondary outcome was 30-day emergency department visits. Risk factors including demographics, surgical approach, and characteristics for 30-day outcomes were examined using odds ratios and chi-square tests for categorical variables and Wilcoxon rank sum tests for continuous variables. RESULTS: Of the 13,445 patients undergoing prolapse surgery, 6171 patients underwent concomitant hysterectomy whereas 7274 did not. Readmission within 30 days was 2.1% for those with and 1.5% for those without a concomitant hysterectomy. Emergency department visit within 30 days was 9.5% in those with and 9.2% in those without a concomitant hysterectomy. Concomitant hysterectomy (adjusted odds ratio, 1.41; 95% confidence interval, 1.07-1.81) was associated with an increased risk of 30-day readmission. There was no difference in risk of 30-day readmission when comparing the various approaches to hysterectomy. When compared with patients who underwent sacrocolpopexy, undergoing a sacrospinous ligament suspension increased the risk (adjusted odds ratio, 2.43; 95% confidence interval, 1.22-4.70) of 30-day readmission, while undergoing uterosacral ligament suspension (adjusted odds ratio, 0.99; 95% confidence interval, 0.57-1.63) or colpocleisis (adjusted odds ratio, 1.79; 95% confidence interval, 0.50-5.24) did not in the concomitant hysterectomy subgroup, when compared with patients who underwent sacrocolpopexy, there was no difference in the risk of 30-day readmission for sacrospinous ligament suspension (adjusted odds ratio, 1.09; 95% confidence interval, 0.61-3.34), uterosacral ligament suspension (adjusted odds ratio, 1.39; 95% confidence interval, 0.61-3.34) or colpocleisis (adjusted odds ratio, 1.88; 95% confidence interval, 0.71-4.02). Similarly, sacrocolpopexy was not associated with an increased risk of emergency department visits in either subgroup. For those who had a concomitant hysterectomy, the patient factors that were associated with an increased 30-day readmission risk were hypertension (odds ratio, 1.54; 95% confidence interval, 1.03-2.31; P=.03) and chronic obstructive pulmonary disease (odds ratio, 2.52; 95% confidence interval, 1.32-4.81; P<.01). For those whose prolapse procedure did not include concomitant hysterectomy, the patient factors that were associated with an increased 30-day readmission risk were age (odds ratio, 1.05; 95% confidence interval, 1.02-1.07; P<.01) and heart failure (odds ratio, 3.26; 95% confidence interval, 1.68-6.33; P<.01). CONCLUSION: In women undergoing minimally invasive pelvic organ prolapse surgery, sacrocolpopexy was not associated with an increased risk of 30-day readmission and emergency department visits. Clinicians may consider surgical approach and other factors when counseling patients about their risks after minimally invasive pelvic organ prolapse surgery.

The Impact of Surgical Center Volume on Reoperation Risk after Mid Urethral Sling.

PURPOSE: We sought to determine whether a center's surgical volume affects patient reoperation rates after mid urethral sling (MUS) surgery. MATERIALS AND METHODS: We performed a retrospective cohort study evaluating a large managed care organization from 2005 to 2016. The primary outcome was the MUS reoperation rate. Perioperative factors and reoperation of patients were compared using Wilcoxon rank-sum for continuous variables and chi-square for categorical variables. We estimated the adjusted hazard ratio and the 95% confidence interval of reoperation using Cox proportional hazards model. RESULTS: Within the managed care system, 13,404 primary MUSs were performed at 11 centers over the study period (19/105 center years were considered low volume). Higher-volume centers (>58 procedures/year based on concentration curve) performed 93% of surgeries in this cohort. Overall reoperation risk for patients of higher-volume centers was smaller than those of lower-volume centers, 4.9% vs 9.8% at 9 years (hazard ratio 0.45 [p <0.01]). Risk of reoperation for recurrent stress urinary incontinence (SUI) for patients was lower in the higher-volume centers, 4% vs 9.1% at 9 years (p <0.01). Patient of higher-volume centers were less likely to have a reoperation for mesh exposure 0.2% vs 0.7% (p <0.01) or infection 0% vs 0.2% (p <0.01). CONCLUSIONS: Patients who had their MUS surgery at a higher-volume medical center were less likely to have any reoperation including for recurrent SUI, mesh exposure or infection. These findings persisted even when controlling for potential covariates including patient demographics and surgeon volume and specialty.

Utilizing Outpatient Pelvic Reconstructive Surgery in the Era of the COVID-19 Pandemic.

OBJECTIVE: The COVID-19 pandemic has created a significant strain on the medical system, creating resource scarcity. We sought to demonstrate the reduction in hospital room utilization after implementation of outpatient pelvic reconstructive surgery. METHODS: We included all minimally invasive reconstructive surgical procedures in this retrospective cohort study within a large managed care organization of 4.5 million members (2008-2018). We queried the system-wide medical record for Current Procedural Terminology (CPT), International Classification of Diseases, Ninth Revision (ICD-9), and International Classification of Diseases, Tenth Revision (ICD-10) codes for all included procedures and patient perioperative data. Categorical variables were compared using χ2 test for categorical variables and the Kruskal-Wallis test for continuous variables. RESULTS: Of the 13,445 patients undergoing pelvic reconstructive surgery, 5,506 were discharged the same day, whereas 7,939 were discharged the next day. Over the 10-year period, patients without hysterectomy had outpatient surgery rates increase from 31.2% to 76.4% (+45.2%), whereas those with hysterectomy increased from 3% to 56.4% (+53.4%). Hospital room utilization decreased by 45,200 room days/100,000 reconstructive procedures without hysterectomy and 53,400 room days/100,000 reconstructive procedures with hysterectomy. When compared to 2008, in 2018 after more widespread adoption of outpatient elective surgery, for the 738 patients undergoing surgery without hysterectomy, 334 less room days were used, whereas 335 less room days were used among the 640 patients who had a surgical procedure with hysterectomy. CONCLUSIONS: The implementation of outpatient pelvic reconstructive procedures leads to a significant reduction in hospital room utilization. Same-day discharge decreases hospital resource utilization, therefore improving hospital access, which may be essential for the delivery of routine care during times of resource scarcity such as the COVID-19 pandemic.

A Novel, Structured Fellow Training Pathway for Robotic-Assisted Sacrocolpopexy.

INTRODUCTION: We developed a novel fellow education pathway for robotic-assisted sacrocolpopexy (RASC) and aimed to compare step-specific and total operative times for RASC performed by Female Pelvic Medicine and Reconstructive Surgery (FPMRS) attendings with those in which FPMRS fellows performed part or all of the RASC. We further aimed to compare complication and readmission rates by fellow involvement. METHODS: We tracked RASC at 1 institution between 2012 and 2018. We recorded times for total procedure, sacrocolpopexy, and 6 individual steps. Fellows were designated F1-F3 by training year. We used independent samples t-tests and analysis of variance for continuous variables and χ2 and Fisher's exact tests for categorical variables. RESULTS: Of 178 RASC procedures, 76 (42.7%) involved fellows. Concomitant procedures included hysterectomy (62.4%), midurethral sling (50%), and colporrhaphy/perineorrhaphy (51.7%). RASC without and with fellows had similar demographic, clinical, and procedural characteristics, except for midurethral sling rate (attending, 42.2% vs fellow, 60.5%; p = 0.02). RASC without and with fellows had similar times for total procedure (208.9 ± 61.0 vs 209.1 ± 48.6 minutes, p = 0.98), sacrocolpopexy (116.9 ± 39.9 vs 122.7 ± 29.2 minutes, p = 0.27), and all RASC steps except docking (attendings, 9.9 ± 8.6 vs fellows, 7.2 ± 7.0 minutes; p = 0.03). Complication rates and severity were similar without and with fellows. There were no readmissions. DISCUSSION/CONCLUSION: Our novel structured training program provides safe limitations for total and step-specific procedural times during fellowship education in RASC. Such training programs warrant further study to determine potential contribution to quality and safety in the teaching environment.

The impact of the 2011 US Food and Drug Administration transvaginal mesh communication on utilization of synthetic mid-urethral sling procedures.

INTRODUCTION AND HYPOTHESIS: We sought to examine the change in utilization of the midurethral sling (MUS) for the treatment of stress urinary incontinence (SUI) after the 2011 US FDA communication regarding transvaginal mesh. METHODS: This is a retrospective cohort study evaluating surgical utilization of MUS at a managed care organization of 4.5 million patients from 2008 to 2016. The primary outcome was the change in utilization of synthetic mesh MUS before and after the July 2011 FDA communication. Secondary outcomes were the changes in surgeon level MUS utilization. RESULTS: MUS procedures decreased from 131 to 116 per 100,000 adult women with a decrease of 11.5% from 2010 to 2012. Year over year utilization of MUS was rapidly increasing (p < 0.01) prior the FDA communication from 116 (in 2008) to 131 (in 2010) per 100,000 women and then significantly declined (p < 0.01) after its release from 135 (in 2011) to 75 (in 2016) per 100,000 women (13% increase vs 44% decrease). The number of surgeons performing MUS increased (p < 0.01) from 172/year to 186/year from 2008 to 2010 (Table 1). This decreased (p < 0.01) from 183/year to 121/year from 2011 to 2016. CONCLUSIONS: MUS for SUI drastically declined after the FDA communication. Despite the 2011 FDA communication concerning only transvaginal mesh for pelvic organ prolapse, there was a significant decrease in MUS with synthetic mesh utilization. Our findings support the importance of continued long-term outcome data regarding the safety and efficacy of MUS and highlight the impact of the FDA warning on MUS utilization.

Percutaneous tibial nerve stimulation maintenance therapy for overactive bladder in women: long-term success rates and adherence.

PURPOSE: Our objectives are to (1) identify predictors of treatment success in women with overactive bladder (OAB) after 1 year of percutaneous tibial nerve stimulation (PTNS) maintenance therapy, (2) identify trends in success rates during that 1 year, and (3) assess maintenance treatment adherence. MATERIALS AND METHODS: A retrospective study of 141 women with OAB was performed with the definition of success based on a Patient Global Impression-Improvement (PGI-I) score of 1 ("very much better") or 2 ("much better") or a PGI-I score of 1, 2, or 3 ("a little better"). Multivariable logistic regression was performed to identify factors associated with treatment response and the Cochrane-Armitage trend test to identify changes in the scores over time. RESULTS: After completing 12 weekly treatments, 141 women initiated maintenance therapy with a mean treatment interval of 29 days. At 1 year, 75/141 (53.2%) had discontinued treatment. Those adherent with treatment had a sustained treatment response, with 66.2% of women reporting a PGI-I score of 1, 2 and 92.3% reporting a PGI-I score of 1, 2, or 3 at 1 year. Considering those women who discontinued maintenance therapy as treatment failures, the success rate of 1 year of maintenance therapy ranged from 30.7%-42.9%. No clinical factors were found to be predictive of maintenance treatment success or failure. CONCLUSIONS: Although an effective treatment for those adherent, discontinuation rates of PTNS maintenance therapy at 1 year are high. Given the low numbers of women referred to maintenance therapy, and the high discontinuation rates, long-term PTNS treatment may be feasible for only a minority of women with OAB.

Anchor vs suture for the attachment of vaginal mesh in a robotic-assisted sacrocolpopexy: a randomized clinical trial.

BACKGROUND: Vaginal mesh attachment can be one of the most time-consuming components of a minimally invasive sacrocolpopexy. OBJECTIVE: To assess the impact on the duration vaginal mesh attachment of using absorbable anchors compared to interrupted sutures for vaginal mesh attachment in robotic-assisted sacrocolpopexy. STUDY DESIGN: This was a single-masked, randomized clinical trial of women with pelvic organ prolapse that underwent a robotic-assisted sacrocolpopexy at 2 clinical sites. The participants were randomized to receive either interrupted delayed absorbable anchors or sutures during the vaginal mesh attachment portion of the surgery. The participants completed validated questionnaires at baseline and at 6 weeks, 6 months, and 12 months after the surgery. A certified examiner, masked to the attachment technique that was used, performed a clinical examination using the Pelvic Organ Prolapse Quantification system and also assessed for mesh exposure and the overall appearance of the vaginal walls using a 10-cm visual analog scale at each follow-up visit. The primary outcome was the vaginal mesh attachment time. The categorical variables were compared using chi-square or Fischer's Exact test, whereas the continuous variables were compared using Student's t-test or Mann-Whitney U test where appropriate. An intention-to-treat analysis was performed. RESULTS: Fifty-three participants were randomized, 26 to mesh attachment with anchor, 27 to mesh attachment with suture, and 81% (21/26) and 93% (25/27) had 12-month follow up respectively. There were no significant differences between the groups with regard to age (P=.12), body mass index (P=.23), stage of prolapse (P=.97), or other preoperative factors. Mesh attachment interval time was faster in the anchor compared to suturing study arm (12.2±7.8 vs 21.2±5.2 minutes; P<.001), while sacrocolpopexy times (107.6±33.2 vs 109.8±21.2 minutes; P=.774) were not different. The ease of placement for the surgeon based on a visual analog scale (P=.16), the appearance of the mesh attachment (P=.07), and the overall satisfaction with the use of the specific attachment type (P=.65) were similar for the arms. There was no difference in perioperative adverse events rates between arms and by 12 months follow-up there were no sacrocolpopexy mesh, anchor, or suture exposures. There was no difference in outcomes at 12 months including composite failure (10% vs 12%; P=.79), patient global impression of improvement (1.06 vs 1.19; P=.27), or patient pelvic pain (9.81 vs 9.67; P=.56). CONCLUSION: In patients undergoing a robotic-assisted sacrocolpopexy, the anchor vaginal mesh attachment technique required significantly less time than suturing. There was no difference between techniques in complications, failure, surgeon, or patient-reported outcomes through 12 months of follow-up. Mesh attachment during sacrocolpopexy can be performed in less time by using the anchor technique, providing surgeons with an alternative surgical technique for this procedure.

Comparison of 30-Day Readmission After Same-Day Compared With Next-Day Discharge in Minimally Invasive Pelvic Organ Prolapse Surgery.

OBJECTIVE: To compare the effect of same-day discharge on 30-day readmission risk after minimally invasive pelvic reconstructive surgery. METHODS: This retrospective cohort study included all minimally invasive pelvic reconstructive procedures with and without concomitant hysterectomy performed within a large managed care organization of 4.5 million members from 2008 to 2018. We queried the system-wide medical record for Current Procedural Terminology and International Classification of Diseases, Ninth and Tenth Revision codes for all included procedures and patient perioperative data. Our primary outcome was 30-day hospital readmission, and our secondary outcome was 30-day emergency department (ED) visits. Perioperative data and 30-day outcomes were compared using χ for categorical variables and Kruskal-Wallis for continuous variables. We performed a multivariate logistic regression adjusting for perioperative variables and their potential effect. RESULTS: Of the 13,445 patients undergoing pelvic reconstructive surgery, 5,506 were discharged the same day and 7,939 were discharged the next day. There was no difference in 30-day readmission comparing those discharged the same day with those discharged the next day (odds ratio [OR] 0.79; 95% CI 0.60-1.03; 1.5% vs 2.0%, P=.07). Concomitant hysterectomy was performed in 6,171 individuals: There was no difference (OR 0.90; 95% CI 0.60-1.33; 1.9% vs 2.1%, P=.59) in 30-day readmission rates when comparing those discharged on the same day with those discharged the next day. We also found no difference in 30-day readmissions rates when comparing same-day with next-day discharge (OR 1.33, 95% CI 0.79-2.26; 2.8% vs 2.1%, P=.28) in (n=3,482) individuals undergoing vaginal hysterectomy. For those who did not undergo hysterectomy at the time of their prolapse surgery, there was no difference (OR 0.77; 95% CI 0.53-1.13; 1.3% vs 1.7%, P=.18) in 30-day readmission when comparing those discharged the same day with those discharged the next day. After adjustment for patient and perioperative characteristics, there was no statistically significant difference in the readmission risk for individuals with same-day discharge compared with next-day discharge among those with (adjusted odds ratio [aOR] 0.91; 95% CI 0.61-1.36; P=.63) and without (aOR 0.86; 95% CI 0.58-1.27; P=.45) a concomitant hysterectomy. For the secondary outcome of 30-day ED visits, we found no statistically significant differences when comparing same-day with next-day discharge for the entire cohort, those with concomitant hysterectomy, or when controlling for patient and perioperative characteristics. CONCLUSION: In women undergoing minimally invasive pelvic reconstructive surgery within a large managed care organization, there is no difference in 30-day readmission or ED visit rates between those discharged the same day and those discharged the next day. When considering patient factors, same-day discharge after minimally invasive pelvic reconstructive surgery may be safe and play an important role in value-based care.

8 versus 12 weeks of percutaneous tibial nerve stimulation and response predictors for overactive bladder.

INTRODUCTION AND HYPOTHESIS: The primary objective is to compare weekly success rates after 8 vs 12 weekly percutaneous tibial nerve stimulation (PTNS) sessions for treatment of overactive bladder (OAB) in women and the secondary objective is to identify treatment response predictors. METHODS: A retrospective study of 470 women was performed with the primary definition of success a Patient Global Impression-Improvement (PGI-I) score of 1 ("very much better") or 2 ("much better") and a ≥ 10-point improvement in both subscales of the Overactive Bladder Questionnaire-Short Form (OABq-SF). Additional analyses were performed to include a success definition of a PGI-I score of 3 ("a little better"). Categorical variables were compared using the Chi-squared test. Multivariate logistic regression was performed to identify factors associated with response. RESULTS: One hundred and thirty-six out of 470 (29%) discontinued treatment before 12 weeks. One hundred out of 334 (29.9%) were successes at 8 weeks vs 138 out of 334 (41.3%) at 12 weeks (p = 0.002). Including a PGI-I score of 3 as an indicator of success, 181 out of 334 (54.2%) at 8 weeks and 202 out of 334 (60.5%) at 12 weeks were successes (p = 0.10). Factors associated with treatment response were neurological disorder (OR 4.32 [1.10-16.04]), prolapse surgery history (OR 3.89 [1.12-14.49]), and vaginal estrogen use (OR 1.76 [1.01-3.08]). Recurrent UTI was associated with failure (OR 0.42 [0.21-0.86]). CONCLUSIONS: The PTNS treatment success rate for OAB in women is greater at 12 weeks than at 8 weeks based on two validated questionnaires, the PGI-I and the OABq-SF. However, the success rates were equivalent if women who are "a little better" are also considered successes; with this definition, clinicians may consider shortening treatment duration to 8 weeks. Four clinical factors were significantly associated with response and may help to guide patient selection.

Long-term Risk of Reoperation After Synthetic Mesh Midurethral Sling Surgery for Stress Urinary Incontinence.

OBJECTIVE: To measure the long-term reoperation risk after synthetic mesh midurethral sling surgery. METHODS: This retrospective cohort study evaluated all patients who underwent a midurethral sling surgery for stress urinary incontinence (SUI) (2005-2016) within a large managed care organization of 4.5 million members. We queried the system-wide medical record for Current Procedural Terminology and International Classification of Diseases, 9 or 10 Revision codes for patient data, and implant registry coding to assess the sling type. The primary outcome was the overall reoperation rate after midurethral sling, with secondary outcomes being reoperation for mesh revision, or removal and recurrent SUI. We used cumulative incidence to calculate reoperation risk as a function of time at least 1 year, least 5 years, and at least 9 years. We compared demographics, characteristics, and reoperation of patients using χ and Wilcoxon rank sum, and we used a Cox proportional hazards model to calculate adjusted hazard ratios. RESULTS: In this cohort of 17,030 patients treated with primary midurethral slings, the overall reoperation rate was 2.1% (95% CI 1.9-2.4%) at 1 year, 4.5% (95% CI 4.1-4.8%) at 5 years, and 6.0% (95% CI 5.5-6.5%) at 9 years. Risk of reoperation was affected by race (P=.04), with Asian or Pacific Islander patients having a lower reoperation rate when compared with white patients. Reoperation rate for mesh revision or removal was 0.7% (95% CI 0.6-0.8%) at 1 year, 1.0% (95% CI 0.8-1.1%) at 5 years, and 1.1% (95% CI 0.9-1.3%) at 9 years. Reoperation for recurrent SUI was 1.6% (95% CI 1.4-1.8%) at 1 year, 3.9% (95% CI 3.5-4.2%) at 5 years, and 5.2% (95% CI 4.7-5.7%) at 9 years. Risk of reoperation for recurrent SUI was affected by the type of sling, with reoperation more common after single-incision compared with retropubic sling (adjusted hazard ratio 1.5 [95% CI 1.06-2.11] P=.03). CONCLUSION: Midurethral slings have a low long-term risk of reoperation for mesh revision or removal, and recurrent SUI, adding to the evidence of their safety and efficacy for the treatment of women with SUI.

Surgeon volume and reoperation risk after midurethral sling surgery.

BACKGROUND: Emerging research supports that fewer complications occur in patients who undergo surgery by higher surgical volume surgeons. The midurethral sling surgery has been involved in recent warnings and litigation, which further supports a need to understand features that enhance its safety and efficacy. OBJECTIVE: The purpose of this study was to measure the impact of a surgeon's volume on their patient's rate of reoperation after midurethral sling surgery. STUDY DESIGN: This was a retrospective cohort study that evaluated all surgeons who performed synthetic mesh midurethral sling surgery for stress urinary incontinence at a large managed care organization with >4.5 million members from 2005-2016. Physicians Current Procedural Terminology and International Classification of Diseases, version 9/10, codes were used to identify the procedures and the reoperations that were performed. The system-wide medical record was queried for demographic and perioperative data. The primary outcome was the overall reoperation rate after midurethral sling surgery. Concentration curves were used to identify the impact of a surgeon's surgical volume on their rate of reoperation. Demographics, characteristics, and reoperation of patients were compared with the use of chi-square test for categoric variables and Wilcoxon rank sum test for continuous variables. Poisson regression models with a robust error variance were used to calculate the unadjusted and the adjusted risk ratios of reoperation with the use of age, body mass index, marital status, race, parity, vaginal estrogen use, sling type, smoking, diabetes mellitus, and menopausal status as covariates. RESULTS: Two hundred twenty-seven surgeons performed 13,404 midurethral sling surgeries over the study period; patients had a mean of 4.4 years of follow up. Higher-volume surgeons (>40 procedures/year, ≥95th percentile) performed 47% of the surgeries in this cohort and had an overall lower rate of reoperation (3.6% vs 4.2%; 95% confidence interval, 0.67-0.94; P=.04) compared with lower-volume surgeons. Higher-volume surgeons had a lower rate of reoperation for surgical failure (2.7% vs 3.6%; 95% confidence interval, 0.55-0.92; P<.01). Rates of reoperation for complications were similar between the 2 groups (1.1% vs 0.9%; 95% confidence interval, 0.82-1.13; P=.32). For patients whose condition required a reoperation secondary to complication, the rates of reoperation for urinary retention (0.9% vs 0.6%; P=.06), mesh exposure (0.2% vs 0.3%; P=.31), hemorrhage/bleeding (0.1% vs 0.0%; P=.11), pain (0.1% vs 0.1%; P=.52), and infection (0.0% vs 0.0%; P=.37) did not differ between higher- and lower-volume surgeons. The risk ratio for reoperation that compared higher- and lower-volume surgeons was 0.83 (95% confidence interval, 0.67-0.98; P=.01) in the adjusted model. CONCLUSION: Although the reoperation rates were low for both higher- and lower-volume surgeons, higher-volume surgeons had lower overall rates of reoperation after midurethral sling surgery. This effect is seen most dramatically in reoperation for surgical failure, in which patients who have surgery with a higher-volume surgeon are 25% less likely to have postoperative stress urinary incontinence that leads to reoperation.

Open sacrocolpopexy and vaginal apical repair: retrospective comparison of success and serious complications.

INTRODUCTION AND HYPOTHESIS: We compared treatment success and adverse events between women undergoing open abdominal sacrocolpopexy (ASC) vs vaginal repair (VAR) using data from women enrolled in one of three multicenter trials. We hypothesized that ASC would result in better outcomes than VAR. METHODS: Participants underwent apical repair of stage 2-4 prolapse. Vaginal repair included uterosacral, sacrospinous, and iliococcygeal suspensions; sacrocolpopexies were via laparotomy. Success was defined as no bothersome bulge symptoms, no prolapse beyond the hymen, and no retreatment up to 24 months. Adverse events were collected at multiple time points. Outcomes were analyzed using longitudinal mixed-effects models to obtain valid outcome estimates at specific visit times, accounting for data missing at random. Comparisons were controlled for center, age, body mass index (BMI), initial Pelvic Organ Prolapse Quantification (POP-Q) stage, baseline scores, prior prolapse repair, and concurrent repairs. RESULTS: Of women who met inclusion criteria (1022 of 1159 eligibile), 701 underwent vaginal repair. The ASC group (n = 321) was older, more likely white, had prior prolapse repairs, and stage 4 prolapse (all p < 0.05). While POP-Q measurements and symptoms improved in both groups, treatment success was higher in the ASC group [odds ratio (OR) 6.00, 95% confidence interval (CI) 3.45-10.44). The groups did not differ significantly in most questionnaire responses at 12 months and overall improvement in bowel and bladder function. By 24 months, fewer patients had undergone retreatment (2% ASC vs 5% VAR); serious adverse events did not differ significantly through 6 weeks (13% vs 5%, OR 2.0, 95% CI 0.9-4.7), and 12 months (26% vs 13%, OR 1.6, 95% CI 0.9-2.9), respectively. CONCLUSIONS: Open sacrocolpopexy resulted in more successful prolapse treatment at 2 years.