Recommendations of the SUFU/AUGS/ICS Female Stress Urinary Incontinence Surgical Publication Working Group: A common standard minimum data set for the literature.

INTRODUCTION AND OBJECTIVES: Relevant, meaningful, and achievable data points are critical in objectively assessing quality, utility, and outcomes in female stress urinary incontinence (SUI) surgery. A minimum data set female SUI surgery studies was proposed by the first American Urological Association guidelines on the surgical management of female SUI in 1997, but recommendation adherence has been suboptimal. The Female Stress Urinary Incontinence Surgical Publication Working Group (WG) was created from members of several prominent organizations to formulate a recommended standard of study structure, description, and minimum outcome data set to be utilized in designing and publishing future SUI studies. The goal of this WG was to create a body of evidence better able to assess the outcomes of female SUI surgery. METHODS: The WG reviewed the minimum data set proposed in the 1997 AUA SUI Guideline document, and other relevant literature. The body of literature was examined in the context of the profound changes in the field over the past 25 years. Through a DELPHI process, a standard study structure and minimum data set were generated. Care was taken to balance the value of several meaningful and relevant data points against the burden of creating an excessively difficult or restrictive standard that would disincentivize widespread adoption and negatively impact manuscript production and acceptance. RESULTS: The WG outlined standardization in four major areas: (1) study design, (2) pretreatment demographics and characterization of the study population, (3) intraoperative events, and (4) posttreatment evaluation, and complications. Forty-two items were evaluated and graded as: STANDARD-must be included; ADDITIONAL-may be included for a specific study and is inclusive of the Standard items; OPTIMAL-may be included for a comprehensive study and is inclusive of the Standard and Additional items; UNNECESSARY/LEGACY-not relevant. CONCLUSIONS: A reasonable, achievable, and clinically meaningful minimum data set has been constructed. A structured framework will allow future surgical interventions for female SUI to be objectively scrutinized and compared in a clinically significant manner. Ultimately, such a data set, if adopted by the academic community, will enhance the quality of the scientific literature, and ultimately improve short and long-term outcomes for female patients undergoing surgery to correct SUI.

Recommendations of the SUFU/AUGS/ICS Female Stress Urinary Incontinence Surgical Publication Working Group: A Common Standard Minimum Data Set for the Literature.

INTRODUCTION AND OBJECTIVES: Relevant, meaningful, and achievable data points are critical in objectively assessing quality, utility, and outcomes in female stress urinary incontinence (SUI) surgery. A minimum data set female SUI surgery studies was proposed by the first American Urological Association guidelines on the surgical management of female SUI in 1997, but recommendation adherence has been suboptimal. The Female Stress Urinary Incontinence Surgical Publication Working Group (WG) was created from members of several prominent organizations to formulate a recommended standard of study structure, description, and minimum outcome data set to be utilized in designing and publishing future SUI studies. The goal of this WG was to create a body of evidence better able to assess the outcomes of female SUI surgery. METHODS: The WG reviewed the minimum data set proposed in the 1997 AUA SUI Guideline document, and other relevant literature. The body of literature was examined in the context of the profound changes in the field over the past 25 years. Through a DELPHI process, a standard study structure and minimum data set were generated. Care was taken to balance the value of several meaningful and relevant data points against the burden of creating an excessively difficult or restrictive standard that would disincentivize widespread adoption and negatively impact manuscript production and acceptance. RESULTS: The WG outlined standardization in four major areas: 1) study design, 2) pretreatment demographics and characterization of the study population, 3) intraoperative events, and 4) post-treatment evaluation, and complications. Forty-two items were evaluated and graded as: STANDARD - must be included; ADDITIONAL - may be included for a specific study and is inclusive of the Standard items; OPTIMAL - may be included for a comprehensive study and is inclusive of the Standard and Additional items; UNNECESSARY/LEGACY - not relevant. CONCLUSIONS: A reasonable, achievable, and clinically meaningful minimum data set has been constructed. A structured framework will allow future surgical interventions for female SUI to be objectively scrutinized and compared in a clinically significant manner. Ultimately, such a data set, if adopted by the academic community, will enhance the quality of the scientific literature, and ultimately improve short and long-term outcomes for female patients undergoing surgery to correct SUI.

Patient perspectives in adverse event reporting after vaginal apical prolapse surgery.

BACKGROUND: Many clinical trials use systematic methodology to monitor adverse events and determine grade (severity), expectedness, and relatedness to treatments as determined by clinicians. However, patient perspectives are often not included in this process. OBJECTIVE: This study aimed to compare clinician vs patient grading of adverse event severity in a urogynecologic surgical trial. Secondary objectives were to estimate the association of patient grading of adverse events with decision-making and quality of life outcomes and to determine if patient perspective changes over time. STUDY DESIGN: This was a planned supplementary study (Patient Perspectives in Adverse Event Reporting [PPAR]) to a randomized trial comparing 3 surgical approaches to vaginal apical prolapse. In the parent trial, adverse events experienced by patients were collected per a standardized protocol every 6 months during which clinicians graded adverse event severity (mild, moderate, severe/life-threatening). In this substudy, we obtained additional longitudinal patient perspectives for 19 predetermined "PPAR adverse events." Patients provided their own severity grading (mild, moderate, severe/very severe/life-threatening) at initial assessment and at 12 and 36 months postoperatively. Clinicians and patients were masked to each other's reporting. The primary outcome was the interrater agreement (kappa statistic) for adverse event severity between the initial clinician and patient assessment, combining patient grades of mild and moderate. The association between adverse event severity and the Decision Regret Scale, Satisfaction with Decision Scale, the 12-Item Short-Form Health Survey, and Patient Global Impression of Improvement scores was assessed using the Spearman correlation coefficient (ρ) for continuous scales, the Mantel-Haenszel chi-square test for Patient Global Impression of Improvement, and t tests or chi-square tests comparing the assessments of patients who rated their adverse events or symptoms as severe with those who gave other ratings. To describe patient perspective changes over time, the intraobserver agreement was estimated for adverse event severity grade over time using weighted kappa coefficients. RESULTS: Of the 360 randomly assigned patients, 219 (61%) experienced a total of 527 PPAR adverse events (91% moderate and 9% severe/life-threatening by clinician grading). Mean patient age was 67 years; 87% were White and 12% Hispanic. Among the patients reporting any PPAR event, the most common were urinary tract infection (61%), de novo urgency urinary incontinence (35%), stress urinary incontinence (22%), and fecal incontinence (13%). Overall agreement between clinician and participant grading of severity was poor (kappa=0.24 [95% confidence interval, 0.14-0.34]). Of the 414 adverse events that clinicians graded as moderate, patients graded 120 (29%) as mild and 80 (19%) as severe. Of the 39 adverse events graded as severe by clinicians, patients graded 15 (38%) as mild or moderate. Initial patient grading of the most severe reported adverse event was mildly correlated with worse Decision Regret Scale (ρ=0.2; P=.01), 12-Item Short-Form Health Survey (ρ=-0.24; P<.01), and Patient Global Impression of Improvement (P<.01) scores. There was no association between adverse event severity and Satisfaction with Decision Scale score. Patients with an initial grading of "severe" had more regret, lower quality of life, and poorer global impressions of health than those whose worst severity grade was mild (P<.05). Agreement between the patients' initial severity ratings and their ratings at 12 months (kappa=0.48 [95% confidence interval, 0.39-0.58]) and 36 months (kappa=0.45 [95% confidence interval, 0.37-0.53]) was fair. CONCLUSION: Clinician and patient perceptions of adverse event severity are discordant. Worse severity from the patient perspective was associated with patient-centered outcomes. Including the patient perspective provides additional information for evaluating surgical procedures.

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.

Intraoperative Predictors of Sacral Neuromodulation Implantation and Treatment Response: Results From the ROSETTA Trial.

PURPOSE: We determined the utility of intraoperative data in predicting sacral neuromodulation outcomes in urgency urinary incontinence. MATERIALS AND METHODS: Intraoperative details of sacral neuromodulation stage 1 were recorded during the prospective, randomized, multicenter ROSETTA trial, including responsive electrodes, amplitudes, and response strengths (motor and sensory Likert scales). Stage 2 implant was performed for stage 1 success on 3-day diary with 24-month follow-up. An intraoperative amplitude response score for each electrode was calculated ranging from 0 (no response) to 99.5 (maximum response, 0.5 V). Predictors for stage 1 success and improvement at 24 months were identified by stepwise logistic regression confirmed with least absolute shrinkage and selection operator and stepwise linear regression. RESULTS: Intraoperative data from 161 women showed 139 (86%) had stage 1 success, which was not associated with number of electrodes generating an intraoperative motor and/or sensory response, average amplitude at responsive electrodes, or minimum amplitude-producing responses. However, relative to other electrodes, a best amplitude response score for bellows at electrode 3 was associated with stage 1 failure, a lower reduction in daily urgency urinary incontinence episodes during stage 1, and most strongly predicted stage 1 outcome in logistic modeling. At 24 months, those who had electrode 3 intraoperative sensory response had lower mean reduction in daily urgency urinary incontinence episodes than those who had no response. CONCLUSIONS: Specific parameters routinely assessed intraoperatively during stage 1 sacral neuromodulation for urgency urinary incontinence show limited utility in predicting both acute and long-term outcomes. However, lead position as it relates to the trajectory of the sacral nerve root appears to be important.

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 Role of Pessaries in the Treatment of Women With Stress Urinary Incontinence: A Systematic Review and Meta-Analysis.

IMPORTANCE: Pessaries are an important conservative therapy for stress urinary incontinence (SUI), but few studies have comprehensively evaluated their utility. OBJECTIVE: The objective of this study is to evaluate the existing evidence on the efficacy and safety of pessaries for the treatment of SUI. STUDY DESIGN: We searched for the terms "stress urinary incontinence" and "pessar/y/ies/ium" in PubMed, Embase, and Cinhal on June 10, 2020. Studies that characterized subjective and/or objective data were included. Studies performed in pediatric populations, pregnancy, and use of pessaries not for SUI were excluded. Two reviewers independently screened and assessed data quality and risk of bias according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: Ten studies, including 376 patients, were included. In terms of subjective outcomes, 76% of 72 patients reported feeling continent after pessary treatment compared with 0% of 86 patients surveyed before pessary use (P < 0.0001). Both Urinary Distress Inventory and Incontinence Impact Questionnaire scores decreased significantly by 46.7% (n = 155 baseline, n = 139 follow-up; P < 0.0001) and 67.8% (n = 139 baseline, n = 107 follow-up; P < 0.0001), respectively. Significant objective measures associated with pessary use included increased urethral closure pressure (n = 122; g = 0.56; 95% confidence interval [CI], -0.66 to 1.77; P < 0.049) and decreased pad weight (n = 129 baseline; n = 118 follow-up; g = -0.89; 95% CI, -1.986 to 0.19; P = 0.009). Adverse events significantly decreased at greater than 6 months follow-up compared with less than 6 months follow-up, including pain (31.5%, n = 29/92 vs 14.3%, n = 5/35; P = 0.0513) and discomfort (50%, n = 46/92 vs 29.3%, n = 12/41; P = 0.0268). CONCLUSIONS: Based on both subjective and objective measures, pessaries are an effective conservative treatment option for SUI. This supports pessary use, though larger studies with longer-term follow-up are warranted.

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.

Cost-effectiveness of behavioral and pelvic floor muscle therapy combined with midurethral sling surgery vs surgery alone among women with mixed urinary incontinence: results of the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence randomized trial.

BACKGROUND: Urinary incontinence is prevalent among women, and it has a substantial economic impact. Mixed urinary incontinence, with both stress and urgency urinary incontinence symptoms, has a greater adverse impact on quality of life and is more complex to treat than either stress or urgency urinary incontinence alone. Studies evaluating the cost-effectiveness of treating both the stress and urgency urinary incontinence components simultaneously are lacking. OBJECTIVE: Cost-effectiveness was assessed between perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery and midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. The impact of baseline severe urgency urinary incontinence symptoms on cost-effectiveness was assessed. STUDY DESIGN: This prospective economic evaluation was performed concurrently with the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence randomized trial that was conducted from October 2013 to April 2016. Participants included 480 women with moderate-to-severe stress and urgency urinary incontinence symptoms and at least 1 stress urinary incontinence episode and 1 urgency urinary incontinence episode on a 3-day bladder diary. The primary within-trial analysis was from the healthcare sector and societal perspectives, with a 1-year time horizon. Costs were in 2019 US dollars. Effectiveness was measured in quality-adjusted life-years and reductions in urinary incontinence episodes per day. Incremental cost-effectiveness ratios of combined treatment vs midurethral sling surgery alone were calculated, and cost-effectiveness acceptability curves were generated. Analysis was performed for the overall study population and subgroup of women with Urogenital Distress Inventory irritative scores of ≥50th percentile. RESULTS: The costs for combined treatment were higher than the cost for midurethral sling surgery alone from both the healthcare sector perspective ($5100 [95% confidence interval, $5000-$5190] vs $4470 [95% confidence interval, $4330-$4620]; P<.01) and the societal perspective ($9260 [95% confidence interval, $8590-$9940] vs $8090 [95% confidence interval, $7630-$8560]; P<.01). There was no difference between combined treatment and midurethral sling surgery alone in quality-adjusted life-years (0.87 [95% confidence interval, 0.86-0.89] vs 0.87 [95% confidence interval, 0.86-0.89]; P=.90) or mean reduction in urinary incontinence episodes per day (-4.76 [95% confidence interval, -4.51 to 5.00] vs -4.50 [95% confidence interval, -4.25 to 4.75]; P=.13). When evaluating the overall study population, from both the healthcare sector and societal perspectives, midurethral sling surgery alone was superior to combined treatment. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone is ≤28% from the healthcare sector and ≤19% from the societal perspectives for a willingness-to-pay value of ≤$150,000 per quality-adjusted life-years. For women with baseline Urogenital Distress Inventory irritative scores of ≥50th percentile, combined treatment was cost-effective compared with midurethral sling surgery alone from both the healthcare sector and societal perspectives. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone for this subgroup is ≥90% from both the healthcare sector and societal perspectives, at a willingness-to-pay value of ≥$150,000 per quality-adjusted life-years. CONCLUSION: Overall, perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery was not cost-effective compared with midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. However, combined treatment was of good value compared with midurethral sling surgery alone for women with baseline severe urgency urinary incontinence symptoms.

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.

Design of a Study to Measure Patient-Perspectives in Adverse Event Reporting (the PPAR Study): Supplementary Study to the ASPIRe Trial.

OBJECTIVES: The primary objective of this study is to compare patient versus physician rankings of adverse event (AE) and adverse symptom (AS) severity after pelvic reconstructive surgery. Secondary objectives include to estimate the association between patient rankings of AEs/ASs with decision-making and quality-of-life outcomes and to determine whether patient perspective about AE/AS changes over time. METHODS: This is a supplementary study, Patient-Perspectives in Adverse Event Reporting (PPAR), to the index trial, ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design). During the trial, AEs/ASs will be assessed by physicians longitudinally every 6 months, which includes a determination of the AE/AS grade severity. For PPAR, additional patient perspective will be measured for 19 predetermined AEs/ASs at the time of identification and again at 12 and 36 months postoperatively. Decision-making and quality-of-life questionnaires will be collected at these time points. The primary outcome, the overall interrater agreement between patient and physician rankings for AE/AS severity, will be determined using a repeated-measures concordance correlation coefficient. RESULTS: To date, the index trial has completed enrollment, and follow-up is ongoing. CONCLUSIONS: The PPAR methods for incorporating patient perspective in the measurement of AEs/ASs to determine their agreement with physician ranking, long-term relevance, and impact on treatment decision making and quality of life are described. This will contribute to improved measurements of AEs/ASs in future research with the goal of improving patient counseling and informing expectations and treatment decision making.

The Design of a Prospective Trial to Evaluate the Role of Preoperative Frailty Assessment in Older Women Undergoing Surgery for the Treatment of Pelvic Organ Prolapse: The FASt Supplemental Trial.

OBJECTIVE: We present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP. METHODS: The selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification. CONCLUSIONS: This trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications.