Impact of Preoperative Urinary Tract Infection Screening in Asymptomatic Women Undergoing Midurethral Sling.

INTRODUCTION: There is limited information regarding the utility of preoperative urine culture (Ucx) screening to decrease postoperative UTI rates following midurethral sling (MUS). HYPOTHESIS: The primary objective of this study was to determine if the rate of postoperative UTI within the first 6 weeks after surgery is lower in women undergoing MUS when preoperative Ucx is obtained compared to when it is not. Secondary objectives were to determine clinical factors associated with postoperative UTI risk. METHODS: This is a retrospective cohort study of women who did not have symptoms of or a diagnosis of cystitis at the time of their preoperative evaluation and are undergoing MUS. Patients were grouped into those who had preoperative Ucx screening within 6 weeks preceding surgery and those who did not. UTI rates 6 weeks following surgery were compared between groups. Additionally, factors impacting the risk of developing a UTI within 6 weeks of surgery were assessed. RESULTS: Among 661 patients, 13.2% had a UTI within the first 6 weeks. There was no significant difference in UTI rates between those who did and did not have preoperative Ucx, respectively (14.9% vs 10.2%, p = 0.09). On multivariable analysis, current smoker status (OR 3.02, 95% CI 1.10-8.26), history of recurrent UTI (OR 3.00, 95% CI 1.14-7.86), and requiring postoperative SIC (OR 8.75, 95% CI 1.83-41.74) were independently associated with a UTI within 6 weeks of MUS. CONCLUSION: Obtaining preoperative Ucx in asymptomatic women prior to MUS does not appear to be associated with lower postoperative UTIs rates within 6 weeks of surgery.

Recurrence of Anterior Vaginal Prolapse After Robotic Sacrocolpopexy: Does Cervical Preservation Affect Outcome?

IMPORTANCE: Anterior vaginal prolapse (AVP) is the most common site of recurrence after sacrocolpopexy (SCP). Supracervical hysterectomy helps to prevent mesh exposure, but it is unclear if cervical preservation (CP) affects adequate reduction of AVP. OBJECTIVE: Our primary objective was to determine the difference in AVP recurrence rates in patients who have undergone SCP with or without CP. Secondary outcomes were composite failure and complications rates. STUDY DESIGN: This was a retrospective cohort analysis of women who underwent robotic SCP between 2012 and 2019 at Kaiser Permanente Southern California. The first cohort included women with CP (prior or concomitant supracervical hysterectomy). The second included women without CP (prior or concomitant total hysterectomy). Primary outcome was defined as recurrent AVP beyond the hymen. Patients without 12-month follow-up were included in demographic and surgical data analysis only. RESULTS: The charts of 373 patients with CP and 175 without CP were reviewed. Women with CP were more likely to undergo concomitant anterior repair at the time of SCP (14% vs 6%, P < 0.01); however, rates of AVP recurrence were not significantly different between groups (5% vs 3%, P = 0.26). Median follow-up time was 26 months (interquartile range, 14-38 months). Composite failure was similar between groups (17% vs 11%, P = 0.12). Women with CP were more likely to experience asymptomatic apical failure (6% vs 1%, P = 0.03). CONCLUSIONS: Cervical preservation at the time of SCP is associated with an increased need for concomitant anterior repair but is not associated with higher rates of AVP recurrence or composite failure.

Urgent PC Versus a Generic Posterior Tibial Neurostimulator for Overactive Bladder: A Retrospective Noninferiority Study.

OBJECTIVE: The aim of the study was to determine whether a generic posterior tibial neurostimulator was noninferior to Urgent PC in the treatment of nonneurogenic OAB, urgency urinary incontinence, and mixed urinary incontinence. Secondary outcomes include rates of starting and completing 3 months of maintenance therapy, treatment success after 3 months, and adverse events. METHODS: We performed a retrospective cohort analysis of women whose nonneurogenic OAB, urgency urinary incontinence, or mixed urinary incontinence was treated with either Urgent PC or a generic posterior tibial neurostimulator. Previous research shows a 55% treatment success rate for posterior tibial nerve stimulation (PTNS). To demonstrate noninferiority with a limit of 14% and 80% power, our analysis required 157 patients per group. RESULTS: We included 267 Urgent PC and 234 generic patients and excluded 51 patients from analysis. A per-protocol analysis demonstrated treatment success in 55.3% (121 of 219) of the Urgent PC and 48.6% (85 of 175) of the generic cohort (P = 0.187). An intention-to-treat analysis showed treatment success in 45.3% (121 of 267) of the Urgent PC and 36.3% (85 of 234) of the generic cohort (P = 0.690). There were no significant differences in rates of starting (82.2% vs 78.2%, P = 0.409) or completing (79.9% vs 70.9%, P = 0.129) 3 months of maintenance therapy, treatment success after 3 months (78.5% vs 73.8%, P = 0.485), and adverse events (0.37% vs 0.85%, P = 1.000) in the Urgent PC versus generic group, respectively. CONCLUSIONS: In this cohort of women undergoing PTNS for nonneurogenic OAB, urgency urinary incontinence, or mixed urinary incontinence, the generic neurostimulator demonstrated noninferior rates of treatment success compared with Urgent PC.

Percutaneous Tibial Nerve Stimulation in Diabetic and Nondiabetic Women With Overactive Bladder Syndrome: A Retrospective Cohort Study.

OBJECTIVES: The primary objective of this study was to compare optimal response ("very much better" or "much better" on the Patient Global Impression of Improvement [PGI-I] index) to posterior tibial nerve stimulation (PTNS) for overactive bladder (OAB) in patients with and without diabetes mellitus. Secondary outcomes included longitudinal data regarding PTNS use in patients with diabetes and controls. METHODS: We performed a retrospective cohort analysis of women in our tertiary care center who completed at least 10 weekly and 1 maintenance PTNS treatments for OAB, excluding patients who were treated with PTNS for a non-OAB primary diagnosis. Participants were grouped into those with diabetes mellitus and those without. Previous research demonstrated a 20% difference in subjective response to anticholinergics in persons with diabetes versus persons without diabetes with OAB. To demonstrate a 20% difference in optimal PGI-I with 80% power, our analysis required 92 patients in each group. RESULTS: We identified 356 patients: 96 with diabetes mellitus, and 260 controls. There was no statistically significant difference in the primary outcome, with 43 (44.8%) of 96 persons with diabetes versus 115 (44.2%) of 260 controls demonstrating optimal PGI-I response (P = 0.92). Among patients with diabetes, no baseline variables were found to predict treatment response, including hemoglobin A1c greater than 7%, diabetes with sequelae, or higher Charlson Comorbidity Index. CONCLUSIONS: In women undergoing PTNS for OAB, the optimal PGI-I response rate is similar in patients with and without diabetes.

Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence.

OBJECTIVE: To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence. METHODS: Four-hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) compared with midurethral sling alone for mixed incontinence with 1-year follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective or objective failure or both. Subjective failure was defined as not meeting the minimal clinical important difference for improvement on the UDI (Urogenital Distress Inventory) total score (26.1 points). Objective failure was defined as not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for persistent urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated. RESULTS: One hundred twelve of 379 (29.6%) women had overall treatment failure, with 56 of 379 (14.7%) undergoing additional treatment but only two needing intervention for stress incontinence. Previous overactive bladder (OAB) medication (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.96, 95% CI 1.17-3.31); detrusor overactivity on cystometrogram (OR 2.25, aOR 2.82, 95% CI 1.60-4.97); and higher volume at first urge (OR 1.03, aOR 1.04, 95% CI 1.01-1.07) were associated with overall failure. Worse UDI-urgency scores were associated with failure, with an added interaction effect in the midurethral sling-alone group. CONCLUSIONS: Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling in women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. Overall, the need for additional urinary treatment was low and primarily for OAB. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01959347.

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.

Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence.

OBJECTIVE: To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence. METHODS: Four hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone for mixed incontinence with 1 year of follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective failure, objective failure, or both. Subjective failure was defined as not meeting the minimal clinically important difference for improvement on the UDI (Urogenital Distress Inventory)-total score (26.1 points). Objective failure was not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated. RESULTS: Previous overactive bladder medication use (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.89, 95% CI 1.10-3.25), detrusor overactivity on cystometrogram (OR 2.25, aOR 2.72, 95% CI 1.53-4.84), body mass index (OR 1.29, aOR 1.27, 95% CI 1.03-1.57), and Valsalva leak point pressure less than 60 cm H2O (OR 1.96, aOR 3.13, 95% CI 1.65-5.94) were associated with overall failure. Worse UDI urgency scores were associated with failure in the midurethral sling-alone group. Sling type (retropubic vs transobturator) was not associated with failure. CONCLUSION: Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. This information is helpful for counseling women with mixed incontinence who are considering surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01959347.

Perioperative outcomes after robotic versus vaginal surgery for pelvic organ prolapse.

The objectives of the study were to compare post-anesthesia care unit opioid use and pain scores, surgical and hospitalization times, and perioperative adverse events rates following robotic sacrocolpopexy (RSC) versus transvaginal uterosacral ligament suspension (USLS). This was a retrospective analysis of women 18 years and older who underwent either robotic sacrocolpopexy (n = 87) or transvaginal uterosacral ligament suspension (n = 103) between January 1, 2015 to December 31, 2017 at Downey Medical Center by two surgeons. Data including nurses' verbal pain scores and opioid use were abstracted from electronic medical records. Adverse events were classified using the Clavien-Dindo scale. Women in the robotic group were older (62 ± 8 years vs 58 ± 11 years, p = 0.005), had higher rate of stage III or IV prolapse [49/87 (56%) vs 15/103 (15%), p < 0.0002], lower postoperative pain scores (2.6 ± 1.8 vs 4.2 ± 2.4, p < 0.0001), and used less opioids (26 ± 17 mg morphine dose equivalent vs 35 ± 24 mg morphine dose equivalent, p = 0.005) than those in the transvaginal group. Readmissions and reoperations for adverse events were not significantly different between the RSC and USLS groups [5/87 (6%) vs 12/103 (12%), p = 0.16], respectively. Moreover, Dindo-Clavien scores of II or higher occurred at similar rates between the two groups [20/87 (23%) vs 26/103 (25%), p = 0.72]. However, patients had a higher rate of prolonged urethral catheterization following USLS (0/87) than RSC (6/103) (p = 0.03). Robotic sacrocolpopexy was associated with less immediate postoperative pain and opioid use compared to uterosacral ligament vaginal suspension.

Association between adjuvant posterior repair and success of native tissue apical suspension.

BACKGROUND: Posterior repairs and perineorrhaphies are often performed in prolapse surgery to reduce the size of the genital hiatus. The benefit of an adjuvant posterior repair at the time of sacrospinous ligament fixation or uterosacral ligament suspension is unknown. OBJECTIVE: We aimed to determine whether an adjuvant posterior repair at transvaginal apical suspension is associated with improved surgical success. MATERIALS AND METHODS: This secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) trial compared 24-month outcomes in 190 participants who had a posterior repair (posterior repair group) and 184 who did not (no posterior repair group) at the time of sacrospinous ligament fixation or uterosacral ligament suspension. Concomitant posterior repair was performed at the surgeon's discretion. Primary composite outcome of "surgical success" was defined as no prolapse beyond the hymen, point C ≤ -2/3 total vaginal length, no bothersome bulge symptoms, and no retreatment at 24 months. The individual components were secondary outcomes. Propensity score methods were used to build models that balanced posterior repair group and the no posterior repair group for ethnographic factors and preoperative Pelvic Organ Prolapse Quantification values. Adjusted odds ratios were calculated to predict surgical success based on the performance of a posterior repair. Groups were also compared with unadjusted χ2 analyses. An unadjusted probability curve was created for surgical success as predicted by preoperative genital hiatus. RESULTS: Women in the posterior repair group were less likely to be Hispanic or Latina, and were more likely to have had a prior hysterectomy and to be on estrogen therapy. The groups did not differ with respect to preoperative Pelvic Organ Prolapse Quantification stage; however, subjects in the posterior repair group had significantly greater preoperative posterior wall prolapse. There were no group differences in surgical success using propensity score methods (66.7% posterior repair vs 62.0% no posterior repair; adjusted odds ratio, 1.07; 95% confidence interval, 0.56-2.07; P = 0.83) or unadjusted test (66.2% posterior repair vs 61.7% no posterior repair; P = 0.47). Individual outcome measures of prolapse recurrence (bothersome bulge symptoms, prolapse beyond the hymen, or retreatment for prolapse) also did not differ by group. Similarly, there were no differences between groups in anatomic outcomes of any individual compartment (anterior, apical, or posterior) at 24 months. There was high variation in performance of posterior repair by surgeon (interquartile range, 15-79%). The unadjusted probability of overall success at 24 months, regardless of posterior repair, decreased with increasing genital hiatus, such that a genital hiatus of 4.5 cm was associated with 65.8% success (95% confidence interval, 60.1-71.1%). CONCLUSION: Concomitant posterior repair at sacrospinous ligament fixation or uterosacral ligament suspension was not associated with surgical success after adjusting for baseline covariates using propensity scores or unadjusted comparison. Posterior repair may not compensate for the pathophysiology that leads to enlarged preoperative genital hiatus, which remains prognostic of prolapse recurrence.

Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial.

Importance: Mixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman's quality of life. Studies evaluating treatments to simultaneously improve both components are lacking. Objective: To determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms. Design, Setting, and Participants: Randomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017. Interventions: Behavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207). Main Outcomes and Measures: The primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms. Results: Among 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change -128.1 points (95% CI, -146.5 to -109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change -114.7 points (95% CI, -133.3 to -96.2). The model-estimated between-group difference (-13.4 points; 95% CI, -25.9 to -1.0; P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only). Conclusions and Relevance: Among women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance. Trial Registration: ClinicalTrials.gov Identifier: NCT01959347.

Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial.

BACKGROUND: Urgency urinary incontinence (UUI) is a chronic condition for which sacral neuromodulation (SNM) (InterStim/Medtronic) and onabotulinumtoxinA (BTX) (BotoxA/Allergan) are utilized. These therapies have not been compared over extended time. OBJECTIVE: To compare UUI episodes (UUIE) over 24 mo following SNM or BTX. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, open-label, randomized, extension trial (February 2012-July 2016) at nine US medical centers involving 386 women with ≥6 UUIE over 3 d inadequately managed by medications. Participants were clinical responders to treatment: ≥50% reduction in UUIEs after SNM placement or 1 mo post BTX. INTERVENTION: SNM (n=194) versus 200 U BTX (n=192). SNM reprogrammings occurred throughout the 24 mo. After 6 mo, two additional BTX injections were allowed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcome: change in mean daily UUIE over 24 mo. SECONDARY OUTCOMES: no UUIE, ≥75% and ≥50% UUIE reduction; Overactive Bladder Questionnaire Short Form; Urinary Distress Inventory short form; Incontinence Impact Questionnaire; Patient Global Impression of Improvement; Overactive Bladder Satisfaction of Treatment Questionnaire; and adverse events (AEs). Primary analysis used a linear mixed model. RESULTS AND LIMITATIONS: Outcome data were available for 260/298 (87%) clinical responders. No difference in decreased mean UUIE was found over 24 mo (-3.88 vs -3.50 episodes/d,95% confidence interval [CI]=-0.14-0.89; p=0.15), with no differences in UUI resolution, ≥75% or ≥50% UUIE reduction. BTX group maintained higher satisfaction (mean difference=-9.14, 95% CI=-14.38--3.90; p<0.001), treatment endorsement (mean difference=-12.16, 95% CI=-17.7--6.63; p<0.001) through 24 mo. Other secondary measures did not differ. Recurrent urinary tract infections (UTIs) were higher after BTX (24% vs 10%; p<0.01), 6% required intermittent catheterization post second injection. SNM revision and removals occurred in 3% and 9% patients, respectively. CONCLUSIONS: Both treatments offered sustainable UUI improvement, and higher BTX dosing had low clean intermittent catheterization rates, but with UTI risk. SNM revision/removal rates were low due to standardized lead placement with strict treatment response definitions. PATIENT SUMMARY: We compared a large group of US women with severe urgency urinary incontinence (UUI) who received sacral neuromodulation (InterStim) or onabotulinumtoxinA (Botox A) therapy during a 2-yr period. We found that both therapies had similar success in reducing UUI symptoms, and adverse events were low. However, women in the BotoxA group had higher satisfaction and endorsement with their treatment, but with a higher chance of a urinary tract infection. We conclude that both therapies offer sustained reduction in daily incontinence over 2 yr.

Quality of Life and Sexual Function 2 Years After Vaginal Surgery for Prolapse.

OBJECTIVE: To longitudinally assess the effect of native tissue vaginal apical prolapse repair with anti-incontinence surgery on quality of life, sexual function, and body image between uterosacral and sacrospinous suspensions. METHODS: A planned secondary analysis was performed on 374 women enrolled in a randomized trial of the two types of native tissue repair for apical prolapse. Condition-specific and generic quality of life, sexual function, overall and de novo dyspareunia, and body image were assessed using validated instruments at baseline; 6, 12, and 24 months postoperatively; and changes from baseline were assessed and compared between surgical groups. General linear mixed models were used for comparisons and clinically significant differences were assessed using minimum important differences. RESULTS: Of the women randomized, 82% had outcomes available at 2 years. Overall, clinically and statistically significant improvements in generic and condition-specific quality of life and sexual function were observed after surgery. Dyspareunia rates decreased from 25% to 16% by 24 months with only 3% of all women undergoing treatment. De novo dyspareunia occurred in 5% and 10% by 12 and 24 months, respectively. Body image scores also significantly improved from baseline. There were no clinically meaningful or statistically significant differences between groups for any of these outcomes (all P>.05). CONCLUSION: Native tissue vaginal prolapse surgery results in statistically and clinically significant improvements in quality of life, sexual function, and body image at 24 months with no significant differences between uterosacral and sacrospinous suspensions. One in 10 women experience de novo dyspareunia but few requested treatment. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00597935.

Adherence to Oral Therapy for Urgency Urinary Incontinence: Results from the Anticholinergic Versus Botox Comparison (ABC) Trial.

OBJECTIVES: Medication adherence with urgency urinary incontinence (UUI) treatment is challenging and the best assessment methodology is uncertain. We sought to describe adherence with anticholinergic (AC) versus placebo (P) by comparing pill counts and MEMSCAP event data and to identify factors associated with adherence. METHODS: The randomized controlled AC versus Botox Comparison trial of women with moderate to severe idiopathic UUI included 126 participants initiating AC plus P bladder injection and 121 receiving P pills plus Botox injection. Adherence data on 243 participants (124 AC and 119 P) were calculated by pill count and MEMSCAP data for each 2-month interval during the 6-month study that allowed for dose escalation/drug change. Overall composite adherence estimates were calculated using the average of both methods and weighted by the duration of each 2-month interval. RESULTS: Treatment groups had no significant differences in dosing duration (P = 0.76) or mean adherence (AC, 83.3% [16.8] vs. P, 84.8% [13.8]). Only 53% of women met the dichotomous outcome of more than 80% adherence during all intervals. Correlation between adherence by pill counts versus MEMSCAP decreased over time with pill counts demonstrating higher adherence than MEMSCAP (r = 0.53, 0.50, and 0.36 for each 2-month interval). Lower adherence was associated with higher baseline incontinence severity and better UUI quality of life for the AC group and with current smoking status in both groups. CONCLUSIONS: Adherence using pill counts and MEMSCAP was reasonably correlated and similar in both the AC and P groups. In the AC group, higher baseline incontinence severity and better UUI Quality of Life were associated with decreased adherence. Smokers were less adherent.

Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial.

IMPORTANCE: More than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery. OBJECTIVE: To compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%. INTERVENTIONS: The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 188); the behavioral intervention was randomization to receive perioperative BPMT (n = 186) or usual care (n = 188). MAIN OUTCOMES AND MEASURES: The primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success. RESULTS: At 2 years, surgical group was not significantly associated with surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]; unadjusted difference, -1.3%; 95% CI, -12.2% to 9.6%; adjusted odds ratio [OR], 0.9; 95% CI, 0.6 to 1.5) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, -0.2%; 95% CI, -7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, -6.7; 95% CI, -19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, -8.0; 95% CI, -22.1 to 6.1), or anatomic success at 24 months. CONCLUSIONS AND RELEVANCE: Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00597935.

Adverse events associated with pelvic organ prolapse surgeries that use implants.

OBJECTIVE: To estimate the rate of vaginal implant exposure associated with biologic grafts and permanent mesh used for pelvic organ prolapse (POP) surgery, to describe treatments used for these complications, and to estimate response rates to these treatments. The secondary aims were to describe the operative and perioperative complications. METHODS: This was a retrospective analysis of female members of Kaiser Permanente Southern and Northern California and Hawaii who underwent POP surgeries with biologic grafts and permanent mesh between September 2008 and May 2010. Inpatient and outpatient electronic medical records were reviewed for postoperative adverse events. RESULTS: During the 21-month period, 1,282 women, mean age of 62 years (±10 standard deviation), median parity of 3 (interquartile range 2-4), and median body mass index of 28 (interquartile range 24-30) underwent prolapse repairs with 1,484 implants with a mean follow-up time of 358 days (±276 standard deviation). Vaginal exposures occurred more often with permanent mesh (53/847 [6%]) than biologic grafts (10/637 [1.6%]) (P<.001). Resolution of vaginal exposure after the first treatment occurred in 24 of 63 (38%), whereas 39 of 63 (62%) required multiple treatments. Surgical excision was performed in 20 of 63 (32%) exposures. Permanent mesh exposures were more likely to require surgical excision (20/53 [38%]) than biologic graft exposures (zero of 10) (P=.02). CONCLUSION: Vaginal exposure occurred more frequently with permanent mesh than biologic graft, may require multiple treatments, and occasionally require surgical excision. LEVEL OF EVIDENCE: : II.

Urinary retention and voiding dysfunction in women with uterine leiomyoma: a case series.

OBJECTIVE: To examine urinary retention as an underreported complication of uterine leiomyoma. Reproductive-aged women with uterine leiomyoma often describe pelvic pressure and menorrhagia, however few complain of complete urinary retention. STUDY DESIGN: We dis-cuss the cases of 8 women who presented to our emergency room with acute urinary retention over a 4-year period. RESULTS: Patients had a mean age of 39 (range, 25-51) and median parity of 1 (range, 0-5). Seven of 8 patients (88%) had posterior-fundal leiomyomas. All patients underwent either myomectomy or hysterectomy with resolution of their urinary retention. CONCLUSION: Incarceration of the posterior or fundal leiomyoma beyond the pelvic brim can push the cervix against the pubic bone, resulting in compression of the bladder neck or urethra. This may explain the etiology of retention and/or voiding dysfunction in some cases. Urinary retention, as a result of leiomyoma, may be overlooked in the initial management of symptomatic patients.

Miniarc single-incision sling for treatment of stress urinary incontinence: 2-year clinical outcomes.

INTRODUCTION AND HYPOTHESIS: We report 2-year data on the effectiveness and safety of the MiniArc single-incision sling in women with stress urinary incontinence. METHODS: This multi-center, prospective, single-arm, industry-sponsored study measured the effectiveness of the MiniArc sling via quantitative (cough stress test and 1-h pad weight test) and qualitative (Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form) measurements. The objective efficacy rate was defined as the number of patients with a negative cough stress test or 1-h pad weight test ≤ 1 g at 2 years. The subjective efficacy rate was determined by patient responses to the UDI-6 question # 3, "Do you experience, and if so, how much are you bothered by urine leakage related to physical activity, coughing, or sneezing?" Secondary objectives were to evaluate procedural variables of implantation and long-term safety. RESULTS: One hundred and eighty women with a mean age of 51.1 years were implanted in the study. Mean procedure time, blood loss, and length of stay were 11.0 min, 41.7 mL and 9.5 h respectively. At 2 years, 142 patients were available for analysis. The objective efficacy rates for the cough stress test (CST) and pad weight test (PWT) were 84.5 % and 80.1 % respectively and the subjective efficacy rate was 92.9 %. Median Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form scores showed statistically significant improvement (p < .001). The most common adverse events included UTI (4.8 %), constipation (3.7 %), and temporary urinary retention (3.2 %). CONCLUSION: MiniArc is a safe and effective surgical procedure for the treatment of SUI in women with follow-up through 2 years.

Perioperative complications and reoperations after incontinence and prolapse surgeries using prosthetic implants.

OBJECTIVE: To estimate the perioperative complication and reoperation rates associated with slings and prolapse repairs using mesh and biologic grafts. METHODS: Analysis of all female members of Kaiser Permanente Southern and Northern California and Hawaii who underwent sling procedures or pelvic organ prolapse surgeries using implanted grafts or mesh between September 1, 2008, and May 31, 2010. Physicians' Current Procedural Terminology Coding System, 4th edition, International Classification of Diseases, 9th Revision, and surgical implant logs were used to identify the procedures performed, implants used, perioperative complications, and readmissions and reoperations within 12 months of the index surgery. RESULTS: During the 21-month period, 4,142 women (mean age 57 years [standard deviation 12.2], median parity 3 [interquartile range 1-4], median body mass index 28 [interquartile range 25-32]) underwent 3,747 (71%) slings and 1,508 (29%) prolapse repair procedures using implanted prostheses. Trocar-related bladder perforations (51 of 3,747 [1.4%]) occurred more commonly than urethral perforations (2 of 3,747 [0.05%]) in sling procedures (P<.001). There were no trocar-related injuries for prolapse repair kit procedures. Mesh-related reoperations after sling procedures were performed for voiding dysfunction or urinary retention (49 of 3,747 [1.3%]), vaginal mesh erosion (30 of 3,747 [0.8%]), and urethral erosion (3 of 3,747 [0.08%]). Reoperations after prolapse procedures were performed more often for vaginal mesh erosion (29 of 858 [3%]) than for biologic graft infection (2 of 650 [0.3%]; P=.01) and were performed more commonly after anterior (19 of 307 [6%]) compared with apical (9 of 487 [2%]) or posterior vaginal mesh repairs (1 of 64 [2%]; P=.018). CONCLUSION: Reoperations for mesh-related complications occurred most often after transvaginal mesh placement in the anterior vagina.

Colporrhaphy compared with mesh or graft-reinforced vaginal paravaginal repair for anterior vaginal wall prolapse: a randomized controlled trial.

OBJECTIVE: To report 2-year outcomes of a randomized controlled trial comparing standard anterior colporrhaphy with reinforced vaginal paravaginal repair using xenograft or synthetic mesh in women with symptomatic anterior vaginal wall prolapse. METHODS: Women with stage II or greater anterior prolapse were randomly assigned to three groups: anterior colporrhaphy, paravaginal repair with porcine dermis, or polypropylene mesh. Outcomes of prolapse stage, quality of life, degree of bother, and sexual symptoms were assessed by blinded examiners and validated measures at 2 years. Anatomic failure was defined as anterior prolapse at stage II or greater. Composite failure was defined as symptoms of "bulge" and anterior prolapse at stage II or greater. Power calculations determined 33 participants per arm would detect a 40% difference in anatomic success between standard and grafted repair. χ, Mann-Whitney U, and Student's t tests were used for comparisons. RESULTS: Of the 99 participants enrolled, 78 (79%) completed a minimum of 2-year follow-up. Those with mesh had a significantly lower anatomic failure rate (18%) than both the porcine (46%, P=.015) and colporrhaphy groups (58%, P=.002). All groups had statistically similar reductions in their prolapse and urinary symptom subscale scores. Composite failure was not statistically different between groups: 13% colporrhaphy, 12% porcine, and 4% mesh. Two reoperations for anterior prolapse occurred in the porcine group. Mesh erosion rates were 14% for the mesh group. CONCLUSION: Vaginal paravaginal repair with polypropylene mesh has the lowest anatomic failure rate when compared with that with xenograft and anterior colporrhaphy without differences in composite failures. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT0139171. LEVEL OF EVIDENCE: I.