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.

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.

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.

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 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.

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.

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.

Evaluation of microscopic hematuria and risk of urologic cancer in female patients.

BACKGROUND: Urologic cancer has a lower prevalence in women compared with men; however, there are no differences in the recommended evaluation for women and men with microscopic hematuria. OBJECTIVES: The purpose of this study was to identify risk factors that are associated with urologic cancer in women with microscopic hematuria and to determine the applicability of a hematuria risk score for women. STUDY DESIGN: We conducted a retrospective cohort study within an integrated healthcare system in Southern California. All urinalyses with microscopic hematuria (>3 red blood cells per high-power field) that were performed from 2009-2015 were identified. Women who were referred for urologic evaluation were entered into a prospective database. Clinical and demographic variables that included the presence of gross hematuria in the preceding 6 months were recorded. The cause of the hematuria, benign or malignant, was entered into the database. Cancer rates were compared with the use of chi-square and logistic regression models. Adjusted risk ratios of urologic cancer were estimated with the use of multivariate regression analysis. We also explored the applicability of a previously developed, gender nonspecific, hematuria risk score in this female cohort. RESULTS: A total of 2,705,696 urinalyses were performed in women during the study period, of which 552,119 revealed microscopic hematuria. Of these, 14,539 women were referred for urologic evaluation; clinical data for 3573 women were entered into the database. The overall rate of urologic cancer was 1.3% (47/3573). In women <60 years old, the rate of urologic cancer was 0.6% (13/2053) compared with 2.2% (34/1520) in women ≥60 years old (P<.01). In women who reported a history of gross hematuria, the rate of urologic cancer was 5.8% (20/346) compared with a 0.8% (27/3227) in women with no history of gross hematuria (P<.01). In multivariate analysis, > 60 years old (odds ratio, 3.1; 95% confidence interval, 1.6-5.9), a history of smoking (odds ratio, 3.2; 95% confidence interval, 1.8-5.9), and a history of gross hematuria in the previous 6 months (odds ratio, 6.2; 95% confidence interval, 3.4-11.5) were associated with urologic cancers. A higher microscopic hematuria risk score was associated with an increased risk of cancer in this test cohort (P<.01). Women in the highest risk group had a urologic cancer rate of 10.8% compared with a rate of 0.5% in the lowest risk group. CONCLUSIONS: In this female population, >60 years old and a history of smoking and/or gross hematuria were the strongest predictors of urologic cancer. Absent these risk factors, the rate of urologic cancer did not exceed 0.6%. A higher hematuria risk score correlated significantly with the risk of urologic cancer in this female test cohort.

Measuring the impact of a posterior compartment procedure on symptoms of obstructed defecation and posterior vaginal compartment anatomy.

INTRODUCTION AND HYPOTHESIS: We hypothesized that there would be a significant difference in changes in obstructed defecation symptoms and posterior compartment prolapse between women who underwent posterior vaginal wall prolapse repair (PR) and those who did not. METHODS: This was a two-site prospective cohort study of women undergoing prolapse or incontinence surgery in which a PR was, or was not, performed at the discretion of the surgeon. Women were assessed using validated obstructed defecation questionnaires and standardized examination measures (including POP-Q, measurement of transverse gh, and assessment for a rectovaginal pocket and laxity) prior to pelvic surgery and 12 weeks after surgery. RESULTS: Of 68 women who underwent surgery, 43 had PR. The PR group had higher obstructed defecation symptoms and greater posterior compartment prolapse at baseline. At 12 weeks, obstructed defecation symptoms had improved significantly more in the PR group than in the no PR group (all p < 0.03). Anatomic outcomes showed greater improvement in point Bp in the PR group (-3.4 vs. -0.7 no PR, p < 0.001) and resolution of the rectovaginal pocket (86 % vs. 42 %, p = 0.002). There were no significant changes in obstructed defecation symptoms or anatomic outcomes from baseline in the no PR group, while the PR group showed significantly improved obstructed defecation symptoms and anatomic outcomes after repair (p < 0.001 for both). CONCLUSIONS: Significant improvements in obstructed defecation symptoms and posterior compartment prolapse were seen after PR, but not in women who did not receive PR. Obstructed defecation symptoms, Bp and rectovaginal pocket were the measures best able to demonstrate improvement after PR. We recommend the use of these measures to assess the impact of surgery in the posterior compartment.

OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.

Importance: Women with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information. Objective: To assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence. Design, Setting, and Participants: Multicenter open-label randomized trial (February 2012-January 2015) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence. Interventions: Cystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA (n = 192) or sacral neuromodulation (n = 189). Main Outcomes and Measures: Primary outcome, change from baseline mean number of daily urgency urinary incontinence episodes over 6 months, was measured with monthly 3-day diaries. Secondary outcomes included change from baseline in urinary symptom scores in the Overactive Bladder Questionnaire Short Form (SF); range, 0-100, higher scores indicating worse symptoms; Overactive Bladder Satisfaction questionnaire; range, 0-100; includes 5 subscales, higher scores indicating better satisfaction; and adverse events. Results: Of the 364 women (mean [SD] age, 63.0 [11.6] years) in the intention-to-treat population, 190 women in the onabotulinumtoxinA group had a greater reduction in 6-month mean number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group (-3.9 vs -3.3 episodes per day; mean difference, 0.63; 95% CI, 0.13 to 1.14; P = .01). Participants treated with onabotulinumtoxinA showed greater improvement in the Overactive Bladder Questionnaire SF for symptom bother (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0 to 13.3; P = .002); treatment satisfaction (67.7 vs 59.8; mean difference, 7.8; 95% CI, 1.6 to 14.1; P = .01) and treatment endorsement (78.1 vs 67.6; mean difference; 10.4, 95% CI, 4.3 to 16.5; P < .001) than treatment with sacral neuromodulation. There were no differences in convenience (67.6 vs 70.2; mean difference, -2.5; 95% CI, -8.1 to 3.0; P = .36), adverse effects (88.4 vs 85.1; mean difference, 3.3; 95% CI, -1.9 to 8.5; P = .22), and treatment preference (92.% vs 89%; risk difference, -3%; 95% CI, -16% to 10%; P = .49). Urinary tract infections were more frequent in the onabotulinumtoxinA group (35% vs 11%; risk difference, -23%; 95% CI, -33% to -13%; P < .001). The need for self-catheterization was 8% and 2% at 1 and 6 months in the onabotulinumtoxinA group. Neuromodulation device revisions and removals occurred in 3%. Conclusions and Relevance: Among women with refractory urgency urinary incontinence, treatment with onabotulinumtoxinA compared with sacral neuromodulation resulted in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance. In addition, it resulted in a higher risk of urinary tract infections and need for transient self-catheterizations.

Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence.

BACKGROUND: Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. METHODS: We performed a double-blind, double-placebo-controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. RESULTS: Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P=0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P=0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P=0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P=0.01) and urinary tract infections (13% vs. 33%, P<0.001). CONCLUSIONS: Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; ClinicalTrials.gov number, NCT01166438.).

A randomized trial of urodynamic testing before stress-incontinence surgery.

BACKGROUND: Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes. METHODS: We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of "much better" or "very much better" on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points. RESULTS: A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, -0.3 percentage points; 95% confidence interval, -7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes. CONCLUSIONS: For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.).

Trends in urodynamics study utilization in a Southern California managed care population.

OBJECTIVE: We examined trends in overall and preoperative urodynamics utilization among women with stress urinary incontinence (SUI) to determine if practice patterns changed following publication of a 2012 randomized trial questioning the value of preoperative urodynamics in patients with uncomplicated SUI. STUDY DESIGN: We collected electronic medical record data on the number of female patient visits to Kaiser Permanente Southern California urology and urogynecology clinics with stress or mixed incontinence, urodynamic studies (UDS) performed, surgeries performed for stress incontinence, and the demographic and clinical characteristics of these patients during 2 discrete time periods before and after a potentially practice-changing publication. We used χ(2) tests and t tests as appropriate. A multivariate logistic regression model was used to estimate the odds of urodynamics performed during January 2013 through June 2014 (study period 2) compared to urodynamics performed during July 2010 through December 2011 (study period 1) after adjustment for demographic and clinical characteristics. RESULTS: In all, 33,775 women were diagnosed as having SUI or mixed urinary incontinence during study period 1 and 37,238 women were diagnosed with these conditions during study period 2. Among these women 12.8% underwent UDS in study period 1 compared to 8.4% in study period 2 (P < .01). The rate of UDS per patient visit decreased 27.0% between the 2 time periods (P < .01). In women undergoing surgery for stress incontinence, urodynamics were performed 56.5% of the time in study period 1 and 46.5% of the time in study period 2. After controlling for demographic, pelvic organ prolapse, and other bladder diagnoses, the odds of urodynamics performed in study period 2 was 0.54 times the odds of urodynamics performed in study period 1 (95% confidence interval, 0.52-0.57). Among women with only the diagnosis of stress incontinence, 1.78% underwent urodynamics in study period 1 compared with 0.84% in study period 2 (P < .01). Preoperative urodynamics decreased from 39% in study period 1 to 20% in study period 2 (P < .01). CONCLUSION: Significantly fewer UDS are being performed overall and prior to stress incontinence surgery in this population. This change may be due to recent studies suggesting low utility of urodynamics in patients with uncomplicated, stress-dominant incontinence.

Uterine sarcomas and parasitic myomas after laparoscopic hysterectomy with power morcellation.

OBJECTIVE: The purpose of this study was to describe the incidence and risk factors for uterine sarcomas and parasitic myomas at the time of power morcellation. STUDY DESIGN: We performed a retrospective review of 3523 women who underwent laparoscopic hysterectomy from 2001-2012. Univariate analyses were used for the morcellation cases to identify potential risk factors. Multivariable logistic regression was performed. RESULTS: Nine hundred forty-one patients underwent power morcellation at the time of hysterectomy; 10 of 941 patients (1.1%) were diagnosed subsequently with uterine sarcomas or parasitic myomas. The overall incidence of uterine sarcoma was 6 of 941 (0.6%), with a median age of 47 years (range, 41-52 years). There was no association among any of the factors analyzed and uterine sarcoma. Three of 6 patients had sarcoma diagnosed on initial pathologic evaluation of the morcellated specimen; 3 patients had delayed diagnosis of sarcoma with benign disease at the time of the initial procedure (median time to second evaluation, 6 years). For parasitic myomas (n=4), the median age was 35 years (range, 32-40 years), and the median time to second evaluation was 5 years. On multivariate analysis, age<40 years (odds ratio, 26; 95% confidence interval, 2.7015-261.9; P≤.01) was associated with higher risk of the development of parasitic myomas. CONCLUSION: Uterine sarcoma was found in 0.6% of patients who underwent power morcellation but was not found to be associated significantly with any preoperative factors. All 6 cases were noted to have apparent fibroid tumors as an indication for their hysterectomy. Age<40 years was a risk factor for parasitic myomas after power morcellation. Patients should be counseled about these complications before power morcellation.

A randomized trial of vaginal mesh attachment techniques for minimally invasive sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: We investigated the efficiency and efficacy of vaginal mesh attachment using interrupted, non-barbed, delayed absorbable sutures in comparison with a running, barbed, delayed absorbable suture during laparoscopic sacrocolpopexy (LSC) and robotic sacrocolpopexy (RSC). METHODS: Women undergoing LSC or RSC were recruited. Participants were randomized to at least six 0 PDS non-barbed interrupted sutures or at least six passes of a 1 PDS barbed suture (Quill™) on each anterior and posterior polypropylene mesh leaflet. The primary outcome was the time to attach the mesh to the vagina. The LSC and RSC groups were block randomized by suture type. Secondary outcomes included: (1) intraoperative surgeon assessment of satisfaction as measured using a 10-cm visual analog scale (VAS), (2) postoperative POP-Q evaluation for anatomic failure, and (3) overall appearance of vaginal walls measured using a VAS. RESULTS: Of the 64 included subjects who were randomized, 32 had mesh attachment with the barbed suture (16 LSC, 16 RSC) and 32 had attachment with non-barbed sutures (16 LSC, 16 RSC). Among all the subjects (LSC and RSC), the non-barbed suture group had significantly longer mesh attachment times than the barbed suture group (42 vs. 29 min, p < 0.001). The non-barbed suture group had significantly better scores for intraoperative ease of suture placement, surgeon satisfaction with mesh appearance, and global satisfaction. At 12 months, there were no significant differences in anatomic failure between the suture groups or overall appearance of the vaginal walls (p > 0.05). CONCLUSIONS: The barbed suture technique was 11 - 16 min faster for attaching mesh to the vagina than the non-barbed suture technique. Anatomic outcomes at 12 months were comparable between the suture groups. It is reasonable to use a running, barbed suture in minimally invasive sacrocolpopexy.