Abdominal and robotic sacrocolpopexy costs following implementation of enhanced recovery after surgery.

OBJECTIVE: To compare perioperative costs and morbidity between open and robotic sacrocolpopexy after implementation of enhanced recovery after surgery (ERAS) pathway. METHODS: The present retrospective cohort study of patients undergoing open or robotic sacrocolpopexy (January 1, 2014, through November 30, 2017) used an ERAS protocol with liposomal bupivacaine infiltration of laparotomy incisions. Primary outcomes were costs associated with index surgery and hospitalization, determined with Medicare cost-to-charge ratios and reimbursement rates and adjusted for variables expected to impact costs. Secondary outcomes included narcotic use, length of stay (LOS), and complications from index hospitalization to postoperative day 30. RESULTS: For the total of 231 patients (open cohort, 90; robotic cohort, 141), the adjusted mean cost of robotic surgery was $3239 higher compared with open sacrocolpopexy (95% confidence interval [CI] $1331-$5147; P < 0.001). Rates were not significantly different for intraoperative complications (robotic, 4.3% [6/141]; open, 5.6% [5/90]; P = 0.754), 30-day postoperative complications (robotic, 11.4% [16/141]; open, 16.7% [15/90]; P = 0.322), or readmissions (robotic, 5.7% [8/141]; open, 3.3% [3/90]; P = 0.535). The percentage of patients dismissed on postoperative day 1 was greater in the robotic group (89.4% [126/141] vs. 48.9% [44/90], P < 0.001). CONCLUSIONS: Decreased LOS associated with ERAS provided significant cost savings with open sacrocolpopexy versus robotic sacrocolpopexy without adverse impacts on perioperative complications or readmissions.

Comparison of outcomes between pessary use and surgery for symptomatic pelvic organ prolapse: A prospective self-controlled study.

PURPOSE: We compared the degree of pelvic floor symptom improvement between pessary use and prolapse surgery. MATERIALS AND METHODS: Pessary-naïve women who elected prolapse surgery were enrolled and used a pessary preoperatively (for ≥7 days and ≤30 days). Pelvic floor symptoms were assessed at baseline, after pessary use, and at 3 months postoperatively. The primary outcome was concordance in the degree of symptoms improvement between pessary use and surgery, as assessed by Patient Global Impression of Improvement (PGI-I). Secondary outcomes were related to prolapse specific symptoms on validated questionnaires (POPDI-6, PFIQ-7). The McNemar test was used for comparisons of discordant pairs for comparisons of the PGI-I ratings after pessary use and surgery. RESULTS: Sixty-one participants were enrolled (March 2016 through April 2019) and 58 patients used a pessary. Mean±standard deviation age was 60.7±10.7 years; 24.1% had prior hysterectomy, and 13.8% had prior prolapse surgery. While both treatments demonstrated symptomatic improvement, concordance in the degree of overall improvement on the PGI-I score was poor (n=40); responses significantly favored more improvement postoperatively (p<0.001). Pessary use and surgery were associated with significant improvements in prolapse symptoms from baseline on POPDI-6 (both p<0.001) and POPIQ-7 (pessary, p=0.002; surgery, p<0.001). The degree of improvement was larger postoperatively compared to post-pessary use on POPDI-6 (p<0.001) and PFIQ-7 (p=0.004). CONCLUSIONS: Both pessary use and surgery significantly improved pelvic floor symptoms from baseline. However, concordance in degrees of improvement between these treatments was poor, with more favorable outcomes after surgery for prolapse symptoms.

Reoperation for Urinary Incontinence After Retropubic and Transobturator Sling Procedures.

OBJECTIVE: To compare the reoperation rates for recurrent stress urinary incontinence (SUI) after retropubic and transobturator sling procedures. METHODS: We conducted a retrospective cohort study of all women who underwent midurethral sling procedures at a single institution for primary SUI between 2002 and 2012. To minimize bias, women in the two groups were matched on age, body mass index, isolated compared with combined procedure, and preoperative diagnosis. The primary outcome was defined as reoperation for recurrent SUI. Secondary outcomes included intraoperative complications and mesh-related complications requiring reoperation after the index sling procedure. RESULTS: We identified 1,881 women who underwent a sling procedure for primary SUI-1,551 retropubic and 330 transobturator. There was no difference between groups in any of the evaluated baseline variables in the covariate-matched cohort of 570 with retropubic slings and 317 with transobturator slings; results herein are based on the covariate-matched cohort. Women undergoing a transobturator sling procedure had an increased risk of reoperation for recurrent SUI compared with women undergoing a retropubic sling procedure (hazard ratio 2.42, 95% CI 1.37-4.29). The cumulative incidence of reoperation for recurrent SUI by 8 years was 5.2% (95% CI 3.0-7.4%) in the retropubic group and 11.2% (95% CI 6.4-15.8%) in the transobturator group. Women in the retropubic group had a significantly higher rate of intraoperative complications compared with women in the transobturator group (13.7% [78/570] vs 4.7% [15/317]; difference=9.0%, 95% CI for difference 5.3-12.6%); the majority of this difference was due to bladder perforation (7.0% [40/570] vs 0.6% [2/317]; difference=6.4%, 95% CI for difference 4.1-8.7%). The cumulative incidence of sling revision for urinary retention plateaued at 3.2% and 0.4% by 5 years in the two groups. CONCLUSION: Women with primary SUI treated with a retropubic sling procedure have significantly lower cumulative incidence of reoperation for recurrent SUI compared with women who were treated with a transobturator sling procedure. Retropubic slings were associated with a higher risk of sling revision for urinary retention.

Assessing the impact of procedure-specific opioid prescribing recommendations on opioid stewardship following pelvic organ prolapse surgery.

BACKGROUND: Nationally, there is increasing concern regarding the volume of opioid medications prescribed postoperatively and the rate of prescription opioid-related adverse events. In evaluation of this, several reports have identified significant variability in postoperative opioid-prescribing patterns, including quantities exceeding patient's needs, especially after minor surgical procedures. However, data regarding patient's postoperative opioids needs following surgery for pelvic organ prolapse are sparse. OBJECTIVE: To design procedure-specific opioid-prescribing recommendations for pelvic organ prolapse surgeries and evaluate their impact on opioid stewardship. STUDY DESIGN: We prospectively evaluated opioid-prescribing patterns, patient use, medication refills, and patient satisfaction in women undergoing prolapse surgery (ie, vaginal, abdominal, or robotic) during an 8-month time period. Two cohorts of women, stratified by whether they had surgery before or after implementation of procedure-specific opioid-prescribing recommendations, were evaluated. Postoperative opioid usage (assessed via pill count), medication refills, and satisfaction with pain management after hospital dismissal were evaluated by telephone call 2 weeks after surgery. Postoperative opioid prescribing and use were recorded after conversion to oral morphine equivalents. RESULTS: Overall, 96 women were included, 57 in the initial baseline cohort, and 39 following implementation of the prescribing recommendations. In the initial cohort, 32.8% of the prescribed oral morphine equivalents (3607/11,007 mg) were consumed. Following implementation of the prescribing recommendations, median oral morphine equivalents prescribed decreased from 200 mg oral morphine equivalents (interquartile range 150, 225) to 112.5 mg oral morphine equivalents (interquartile range 22.5, 112.5; P<.0001). The total oral morphine equivalents prescribed decreased by 45% when compared with the volume that would have been prescribed before implementing the recommendations. The amount of leftover opioids per patient significantly decreased as well (P<.0001). Pain medication refills increased after the intervention (18% vs 3.5%; P=.03), whereas satisfaction scores were similar in both cohorts (P=.87). CONCLUSIONS: By using procedure-specific opioid prescribing recommendations, we decreased the number of opioids prescribed at hospital dismissal by roughly one half. Decreased opioid prescribing did not adversely impact patient satisfaction.

Can Urodynamic Parameters Predict Sling Revision for Voiding Dysfunction in Women Undergoing Synthetic Midurethral Sling Placement?

OBJECTIVE: The objective of the study was to evaluate the utility of urodynamic studies performed before primary midurethral sling placement for stress urinary incontinence in predicting the need for subsequent sling release for voiding dysfunction. METHODS: The health records of women managed with primary synthetic midurethral sling placement at Mayo Clinic (Rochester, MN) from January 1, 2002, to December 31, 2012, were reviewed. The primary outcome was surgical sling release for postoperative voiding dysfunction (ie, prolonged retention, elevated postvoid residual volumes with new voiding symptoms, or de novo onset or worsening of overactive bladder symptoms). Logistic regression models were used to evaluate associations between potential clinical risk factors and the primary outcome. RESULTS: Overall, 1629 women underwent primary synthetic midurethral sling placement during the study time frame, including 1081 patients (66%) who underwent a preoperative multichannel urodynamic evaluation. A sling release for voiding dysfunction was performed for 51 patients (3.1%) at a median of 1.9 months postoperatively (interquartile range, 1.3-9.3 months). Patients undergoing sling release were significantly more likely to have had retropubic sling placement (P = 0.003) and concomitant prolapse surgery (P = 0.005). On univariate analysis, no urodynamic parameters were associated with the risk of sling release; evaluated parameters included peak flow rate (P = 0.20), postvoid residual volume (P = 0.37), voiding without detrusor contraction (P = 0.96), and detrusor pressure at maximal flow (P = 0.23). CONCLUSIONS: Sling release for voiding dysfunction was rare in our cohort. No urodynamic parameters were associated with the risk of sling release.

Randomized controlled trial of silver-alloy-impregnated suprapubic catheters versus standard suprapubic catheters in assessing urinary tract infection rates in urogynecology patients.

INTRODUCTION AND HYPOTHESIS: Catheter-associated urinary tract infections (UTI) are the most common health-care-related infections. We aimed to compare the UTI rate among women undergoing urogynecological procedures with a silver-alloy suprapubic catheter (SPC) and a standard SPC, and identify the risk factors predisposing patients to UTI. METHODS: Patients who were to undergo placement of an SPC as part of pelvic organ prolapse surgery were enrolled between 1 August 2011 and 30 August 2017, and randomized to either standard SPC or silver-alloy SPC. Follow-up was performed at a postoperative visit or via a phone call at 6 weeks. The primary outcome was UTI. RESULTS: Of the 288 patients who were randomized, 127 with standard SPC and 137 with silver-alloy SPC were included in the analysis. Twenty-nine out of 123 women with standard SPC (23.6%) and 24 out of 131 (18.3%) with silver-alloy SPC were diagnosed with UTI within 6 weeks postoperatively (p = 0.30). In univariate analysis, non-white race (odds ratio [OR] 5.36, 95% CI 1.16-24.73) and diabetes (OR 2.80, 95% CI 1.26-6.23) were associated with increased risk of UTI. On multivariate analysis, only diabetes remained an independent risk factor. Comparisons between groups were evaluated using two-sample t test for age, Chi-squared tests for diabetes, and Wilcoxon rank sum test for all other variables. CONCLUSION: There was only a 5% difference in 6-week UTI rates between those who received standard vs silver-alloy SPC; the study was not powered to detect such a small difference. Diabetes was identified as a risk factor for SPC-associated UTI in women undergoing pelvic reconstructive surgeries.

Long-term outcomes and predictors of failure after surgery for stage IV apical pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare outcomes after uterosacral ligament suspension (USLS) or sacrocolpopexy for symptomatic stage IV apical pelvic organ prolapse (POP) and evaluate predictors of prolapse recurrence. METHODS: The medical records of patients managed surgically for stage IV apical POP from January 2002 to June 2012 were reviewed. A follow-up survey was sent to these patients. The primary outcome, prolapse recurrence, was defined as recurrence of prolapse symptoms measured by validated questionnaire or surgical retreatment. Survival time free of prolapse recurrence was estimated using the Kaplan-Meier method, and Cox proportional hazards models evaluated factors for an association with recurrence. RESULTS: Of 2633 women treated for POP, 399 (15.2%) had stage IV apical prolapse and were managed with either USLS (n = 355) or sacrocolpopexy (n = 44). Those managed with USLS were significantly older (p < 0.001) and less likely to have a prior hysterectomy (39.7 vs 86.4%; p < 0.001) or prior apical prolapse repair (8.2 38.6%; p < 0.001). Median follow-up was 4.3 years [interquartile range (IQR) 1.1-7.7]. Survival free of recurrence was similar between USLS and sacrocolpopexy (p = 0.43), with 5-year rates of 88.7 and 97.6%, respectively. Younger age [adjusted hazard ratio (aHR) 1.55, 95% confidence interval (CI) 1.12-2.13; p = 0.008] and prior hysterectomy (aHR 2.8, 95% CI 1.39-5.64; p = 0.004) were associated with the risk of prolapse recurrence, whereas type of surgery approached statistical significance (aHR 2.76, 95% CI 0.80-9.60; p = 0.11). CONCLUSIONS: Younger age and history of prior hysterectomy were associated with an increased risk of recurrent prolapse symptoms. Notably, excellent survival free of prolapse recurrence were obtained with both surgical techniques.

Two-Year Results of Burch Compared With Midurethral Sling With Sacrocolpopexy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate 1- and 2-year urinary continence rates after Burch retropubic urethropexy compared with a retropubic midurethral sling for women with urinary incontinence undergoing sacrocolpopexy. METHODS: We conducted a planned secondary analysis of a multicenter, randomized, single-blind trial comparing Burch with a sling that enrolled participants from June 2009 to August 2013. Objective outcome measures of continence were assessed at 1- and 2-year follow-up through office visits and validated questionnaires. Overall continence was defined as a negative stress test, no retreatment for stress incontinence, and no self-reported urinary incontinence (International Consultation on Incontinence Questionnaire, Short Form, score, 0). Stress-specific continence was defined as fulfillment of the first two criteria and no self-reported stress-related incontinence. Primary outcomes were assessed with intention-to-treat and within-protocol analyses. Comparisons between groups were evaluated using χ or Fisher exact test. RESULTS: The two groups were similar in all measured baseline features. Outcome assessments at 2 years were available for 48 of 57 patients (84%) in the sling group and 45 of 56 patients (80%) in the Burch group. With intention-to-treat analysis, the sling group had significantly higher rates of overall continence than the Burch group (49% [28/57] vs 29% [16/56]; 95% CI for absolute risk difference 3.0-38.1; P=.03) at 1- but not 2-year follow-up (47% [27/57] vs 32% [18/56]; 95% CI for absolute risk difference -2.6 to 33.1; P=.10). The sling group had significantly higher rates of stress-specific continence than the Burch group at 1-year (70% [40/57] vs 46% [26/56]; 95% CI for absolute risk difference 6.1-41.4; P=.01) and 2-year (70% [40/57] vs 45% [25/56]; 95% CI for absolute risk difference 7.9-43.2; P=.006) follow-up. No difference was detected in prolapse recurrence, voiding dysfunction, antimuscarinic medication use, urgency incontinence, or patient satisfaction. CONCLUSION: Among women with baseline urinary incontinence undergoing sacrocolpopexy, the retropubic midurethral sling resulted in higher stress-specific continence rates than Burch retropubic urethropexy at 1- and 2-year follow-up.

Outcomes of Robotic Sacrocolpopexy Using Only Absorbable Suture for Mesh Fixation.

OBJECTIVE: The optimal suture selection for mesh attachment during robotic sacrocolpopexy (RSC) is currently unknown. Here, we sought to evaluate the outcomes of RSC using absorbable sutures for vaginal and sacral mesh attachment. METHODS: We retrospectively reviewed 132 RSC surgeries that were performed for vaginal vault prolapse in the Division of Gynecologic Surgery at our institution from February 2007 to December 2013. All cases were performed with absorbable suture (polyglactin) for vaginal and sacral mesh fixation. Sacrocolpopexy failure was defined as patients undergoing either repeat prolapse surgery or pessary use for recurrent prolapse. The durability of RSC was assessed via Kaplan-Meier method. RESULTS: The median age at surgery was 61.1 years (interquartile range [IQR], 55.6-68.2) and the median length of postoperative follow-up was 33 months (IQR, 15.7-57). The median body mass index was 26.5 kg/m (IQR, 24.3-29.7). During follow-up, 10 patients underwent prolapse retreatment. There were 2 apical recurrences, 4 distal anterior recurrences, 2 posterior recurrences, and, in 2 cases, the location was unknown. One apical recurrence was confirmed to be secondary to detachment of the mesh from the sacral promontory. Among those with recurrence, the median time to recurrence was 15.5 months (IQR, 4.22-35.9). Overall, the 1-year and 3-year freedom from repeat surgery rates were 96% and 93%, respectively. CONCLUSIONS: With a median follow-up of 33 months, the use of absorbable suture for both vaginal and sacral attachments during RSC is effective. Further studies evaluating suture selection and mesh attachment techniques for RSC are needed.

Perioperative Complications and Cost of Vaginal, Open Abdominal, and Robotic Surgery for Apical Vaginal Vault Prolapse.

OBJECTIVES: To determine the rate of perioperative complications and cost associated with Mayo-McCall culdoplasty (MMC), open abdominal sacrocolpopexy (ASC), and robotic sacrocolpopexy (RSC) for posthysterectomy vaginal vault prolapse. METHODS: We retrospectively searched for the records of patients undergoing posthysterectomy apical vaginal prolapse surgery (MMC, ASC, or RSC) between January 1, 2000, and June 30, 2012, at our institution. For all patients identified, perioperative complications, length of hospital stay, and inpatient costs to patients were abstracted from the medical records and compared by procedure. Inverse-probability-of-procedure weighting using propensity scores was used to obtain less-biased comparisons of outcomes between procedures. RESULTS: A total of 512 patients met the inclusion criteria (174 MMC, 237 ASC, and 101 RSC). Using inverse-probability weighting, the MMC group had a significantly lower intraoperative complication rate (3.3% vs 11.6% for ASC, 3.4% vs 24.1% for RSC), median operative time (94 vs 217 min for ASC, 100 vs 228 min for RSC), and median cost (US $8,776 vs $12,695 for ASC, US $8,773 vs $13,107 for RSC) than the ASC and RSC groups (all P < 0.01). In addition, the MMC group had significantly fewer postoperative grade 3+ complications than the RSC group (1.1% vs 9.4%, P < 0.01). CONCLUSIONS: In the treatment of posthysterectomy vaginal vault prolapse, MMC is associated with decreased non-urinary tract infection, less perioperative morbidity, and lower cost to patients compared with sacrocolpopexy.

Female Urethral Diverticulum: Presentation, Diagnosis, and Predictors of Outcomes After Surgery.

INTRODUCTION AND HYPOTHESIS: To report on clinical presentation, diagnosis, and outcomes after treatment of female urethral diverticulum (UD). METHODS: Using a record linkage system, women with a new diagnosis of UD at Mayo Clinic from January 1, 1980, through December 31, 2011, were identified. The presenting symptoms, clinical characteristics, diagnosis, and management of women presenting with UD were recorded. Outcomes after surgery were assessed using survival analysis. All statistical analyses were 2-sided and P values less than 0.05 were considered significant. Statistical analysis was done using SAS version 9.2 and JMP version 9.0 (SAS Institute Inc.). RESULTS: A total of 164 cases were identified. Median age at diagnosis was 46 years (range, 21-83). The most common presenting symptom was recurrent urinary tract infection (98, 59.8%), followed by urinary incontinence (81, 49.4%), dysuria (62, 37.8%), dyspareunia (37, 22.6%), and hematuria (15, 9.1%). Examination revealed vaginal mass in 55 (33.5%) of the women. A significant trend was noted toward an increase in use of both magnetic resonance imaging and computed tomography (P < 0.001) along with a progressive decrease in use of urethrogram (P < 0.001) for diagnosis of UD over the years. Among 114 women who underwent surgical treatment for UD, 14(12.3%) women presented with recurrent UD and the 5-year recurrence rate after surgery for UD was 23.4% (95% confidence interval, 13.9-37.0) and a reoperation rate of 17.0% (95% confidence interval, 8.8-30.2) at 5 years. CONCLUSIONS: Female UD is a rare and unique condition. Clinical presentation is usually nonspecific, and magnetic resonance imaging is commonly used for confirming the diagnosis. Recurrence is not uncommon, and repeat surgical intervention might be needed.

Burch Retropubic Urethropexy Compared With Midurethral Sling With Concurrent Sacrocolpopexy: A Randomized Controlled Trial.

OBJECTIVE: To compare efficacy and safety of retropubic Burch urethropexy and a midurethral sling in women with stress urinary incontinence (SUI) undergoing concomitant pelvic floor repair with sacrocolpopexy. METHODS: Women were randomly assigned to Burch retropubic urethropexy (n=56) or retropubic midurethral sling (n=57) through dynamic allocation balancing age, body mass index, history of prior incontinence surgery, intrinsic sphincter deficiency, preoperative incontinence diagnosis, and prolapse stage. Overall and stress-specific continence primary outcomes were ascertained with validated questionnaires and a blinded cough stress test. RESULTS: Enrollment was June 1, 2009, through August 31, 2013. At 6 months, no difference was found in overall (29 midurethral sling [51%] compared with 23 Burch [41%]; P=.30) (odds ratio [OR] 1.49, 95% confidence interval [CI] 0.71-3.13) or stress-specific continence rates (42 midurethral sling [74%] compared with 32 Burch [57%]; P=.06) (OR 2.10, 95% CI 0.95-4.64) between groups. However, the midurethral sling group reported greater satisfaction (78% compared with 57%; P=.04) and were more likely to report successful surgery for SUI (71% compared with 50%; P=.04) and to resolve pre-existing urgency incontinence (72% compared with 41%; P=.03). No difference was found in patient global impression of severity or symptom improvement, complication rates, or mesh exposures. CONCLUSION: There was no difference in overall or stress-specific continence rates between midurethral sling and Burch urethropexy groups at 6 months. However, the midurethral sling group reported better patient-centered secondary outcomes.

Evaluation of the local carcinogenic potential of mesh used in the treatment of female stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: To evaluate the carcinogenic potential of implanted synthetic mesh midurethral slings in the treatment of female stress urinary incontinence. METHODS: We identified female patients undergoing implantation of mesh materials for stress urinary incontinence at our institution from 1 January 2002 to 31 December 2012. This was accomplished by querying the medical records for CPT code 57288 ("sling operation for stress incontinence") and a subsequent chart review to identify patients who underwent synthetic mesh sling placement. Medical records were then evaluated for the documentation of bladder, urethral, vaginal, cervical, uterine or ovarian cancers via the International Classification of Disease (ninth edition) coding. A chart review of patients with a cancer diagnosis was performed for verification of the diagnosis and evaluation of the temporal relationship with sling placement. RESULTS: During the study period, 2,474 patients underwent polypropylene midurethral sling placement. The median age was 57 years (IQR 47, 69) and the median follow-up was 60 months (IQR 23.3, 94.9). Overall, 51 patients also had a cancer diagnosis (8 bladder cancers, 7 vaginal malignancies, 8 ovarian carcinomas, 26 endometrial cancers, 2 cervical malignancies); however, only 2 cancers (0.08 %, 2 out of 2,474) developed following sling placement (a vaginal melanoma 3 years after sling placement and an ovarian tumor 1 year after sling placement). No cases of sarcoma formation, bladder, urethral or squamous cell carcinomas were identified. CONCLUSIONS: With a median follow-up of 5 years after synthetic midurethral sling placement, development of pelvic malignancy was rare (0.08 %) and unlikely to be secondary to foreign body reaction from the implanted material.

Patient Satisfaction After Sling Revision for Voiding Dysfunction After Sling Placement.

OBJECTIVE: The aim of this study was to evaluate patient-reported outcomes after sling release for obstructive voiding after sling operation for female stress urinary incontinence. METHODS: All female patients who had sling release for obstructive voiding at Mayo Clinic in Rochester, Minnesota, from January 1, 2000, through October 31, 2008, were identified and mailed a survey including validated questions for voiding symptoms. A composite outcome for surgical success was chosen in which participants reported global improvement (at least "much better") and complete satisfaction on a 7-point Likert scale. Logistic regression analysis was used to identify clinical and surgical predictors of this outcome. RESULTS: In total, 101 women were identified, of which 98 were alive at the time of mailing, and 55 women (56.1%) responded to the survey. Surgery before sling release was a synthetic midurethal sling in 62 patients and biologic sling in 39 patients. Clinical characteristics among mailing responders and nonresponders were similar aside from time from revision surgery to survey (median, 38.8 vs 54.6 months; P = 0.05). Overall, 23 (41.8%) of the 55 responding patients met the predefined criteria for surgical success. Multivariable analysis identified age younger than 60 years (odds ratio [OR], 4.22; P = 0.02), absence of overactive bladder symptoms before sling release (OR, 3.99; P = 0.04), and type of sling release (sling incision or loosening vs partial or complete excision) (OR, 3.78; P = 0.05) as predictors of success. CONCLUSIONS: Of responders, 23 (41.8%) reported global improvement and satisfaction. Younger age, lack of documented overactive bladder symptoms before sling release, and performing sling release with sling incision or loosening rather than partial or complete excision were associated with better satisfaction and patient-reported improvement.

Assessing the learning curve of robotic sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: The aim was to evaluate the learning curve of robotic sacrocolpopexy, adjusted for surgical risk. METHODS: The charts of 145 robotic sacrocolpopexies performed by urogynecologists at Mayo Clinic, Rochester, MN, USA, from 2007 to 2013, were reviewed. Outcomes of interest included operative time, intraoperative complications, and postoperative complications with a Clavien-Dindo grade 2 or higher. Risk-adjusted cumulative summation analysis was performed by comparing a calculated complication risk score with observed patient outcomes, and then cumulatively recalculating the rate of expected vs observed complications after each procedure. Proficiency was defined as the point at which the surgeon's complication rates were better than expected, given the patient's risk factors. RESULTS: The median operative time decreased significantly, from 5.3 to 3.6 h, during the 7-year period, and plateaued after the first 60 cases. A higher ASA classification was associated with an increased risk of intraoperative complications (p = 0.02), and a higher Charlson comorbidity index was associated with an increased risk of intraoperative or postoperative complications (p = 0.01). In risk-adjusted CUSUM analyses, accounting for these factors, and for body-mass index and vaginal parity, proficiency was identified at 55 cases for intraoperative complications and 84 cases for intraoperative or postoperative complications. CONCLUSIONS: Operative time plateaued after the first 60 cases, whereas complication rates continued to decrease beyond this. Proficiency, as determined by a risk-adjusted CUSUM analysis for complication rates, was achieved after approximately 84 cases. Evaluation of postoperative complications in addition to intraoperative complications, in a risk-adjusted model, is critical in depicting the surgical learning curve.

Comparison of Short Term Outcomes of Sacral Nerve Stimulation and Intradetrusor Injection of OnabotulinumtoxinA (Botox) in Women With Refractory Overactive Bladder.

OBJECTIVES: The aim of the study was to compare the short-term outcomes of sacral nerve stimulation (SNS) and intradetrusor injection of OnabotulinumtoxinA (Botox) for overactive bladder (OAB) symptoms refractory to behavioral modifications and pharmacologic therapy. METHODS: This is a retrospective cohort study evaluating the outcomes of SNS and Botox procedures that were performed for refractory OAB symptoms at a tertiary care referral center. The primary outcome was "failure" of treatment that was defined as less than 50% improvement from the baseline symptoms at 6 months. RESULTS: Sixty-five SNS and 63 Botox procedures met the inclusion criteria. Women undergoing Botox were more likely to report failure 6 months after the intervention as compared with those undergoing SNS (20 [31.8%] vs 7 [10.8%], P = 0.003; unadjusted odds ratio = 3.85, confidence interval = 1.5-9.93; adjusted odds ratio = 4.47, confidence interval = 1.69-14.4). However, there was no difference in the proportion of women who were started on antimuscarinic medications for persistent urgency urinary incontinence after both procedures (12 [18.5%] women in SNS group and 17 [27%] women in the Botox group, P = 0.249). The most common complication of the SNS procedure was wound related (8 [12.3%]), whereas the most common complication of the Botox procedure was urinary tract infection (31 [49.2%]). CONCLUSIONS: The SNS resulted in lower failure rates at 6 months when performed for refractory OAB symptoms as compared with the Botox procedure. However, further studies are needed to evaluate the long-term cost-effectiveness of both procedures.

Health-related quality of life and outcomes after surgical treatment of complications from vaginally placed mesh.

INTRODUCTION AND HYPOTHESIS: We aimed to report on health-related quality of life after surgical excision of vaginally placed mesh for treatment of pelvic organ prolapse and to identify predictors of successful surgical management. METHODS: We identified patients who underwent surgery for treatment of complications from vaginally placed mesh from January 1, 2003, through December 31, 2011, and conducted a follow-up survey. Logistic regression models were used to identify predictors of successful treatment. RESULTS: We identified 114 patients who underwent surgery for mesh-related complications and 68 underwent mesh excision. Of the 68 patients, 44 (64.7%) completed the survey. Of the 44 responders, 41 returned their consent form and were included in the analysis. Only 22 (54%) patients reported a successful outcome after mesh excision. Of 29 (71%) sexually active patients, 23 had dyspareunia before mesh excision and only 3 patients reported resolution of dyspareunia after excision. We reported a multivariable model for predicting successful surgical outcome with an area under the curve for the receiver operator characteristic of 0.781. In this model, complete excision of mesh, new overactive bladder symptoms after mesh placement, and a body mass index higher than 30 kg/m were associated with successful patient-reported outcomes; adjusted odds ratios (95% confidence intervals) were 5.46 (1.10-41.59), 7.76 (1.18-89.55), and 8.41 (1.35-92.41), respectively. CONCLUSIONS: Only half of the patients who had surgery for vaginally placed mesh complications reported improvement after surgery, with modest improvement in dyspareunia. Patients who had complete mesh excision, new overactive bladder symptoms, and obesity were more likely to report improvement.

Perioperative complications of robotic sacrocolpopexy for post-hysterectomy vaginal vault prolapse.

INTRODUCTION AND HYPOTHESIS: Open abdominal sacrocolpopexy has been the preferred treatment for post-hysterectomy vaginal vault prolapse. In light of the rise in popularity of less invasive robotic sacrocolpopexy, our objective was to compare perioperative complications of robotic vs open sacrocolpopexy. METHODS: This was a single-institution, retrospective cohort study of robotic and open sacrocolpopexies. Robotic sacrocolpopexies performed between 1 January 2007 and 31 December 2009 were compared with open cases performed between 1 January 2002 and 31 December 2006. Baseline and intraoperative variables of the groups were compared. Complications were compared univariately and in a multivariable logistic regression model to adjust for prior transabdominal surgery. RESULTS: A total of 50 robotic and 87 open sacrocolpopexies were analyzed. Baseline characteristics were similar, but patients in the open group had more prior transabdominal surgeries. The robotically assisted group had decreased estimated blood loss (median, 100 mL vs 150 mL; P = 0.002) and hospital stay (median, 2 days vs 3 days; P < 0.001), but increased operative time (median, 4.6 vs 2.9 h; P < 0.001), cystotomy (10.0 % [5 out of 50] vs 1.1 % [1 out of 87]; P = 0.02), and vaginotomy (24.0 % [12 out of 50] vs 5.7 % [5 out of 87]; P = 0.003). Two patients in the robotically assisted group had postoperative hernia. There were no differences in rates of ureteral or bowel injury, urinary tract infection, ileus, bowel obstruction, or overall complications. CONCLUSIONS: Overall complication rates of robotic and open sacrocolpopexy were not significantly different. The robotically assisted group experienced shorter hospital stay but increased operative times and increased incidence of cystotomy and vaginotomy, possibly reflecting the learning curve of robotic sacrocolpopexy.

A cohort study comparing a single-incision sling with a retropubic midurethral sling.

INTRODUCTION AND HYPOTHESIS: Despite established comparable efficacy between retropubic midurethral (RMUS) and transobturator slings, there are conflicting data regarding single-incision mini-slings (SIMS). This study tests the null hypothesis that the MiniArc® Single-Incision Sling is equivalent to the ALIGN® Urethral Support System for treatment of stress urinary incontinence (SUI). METHODS: Women who underwent a sling for SUI from 1 January 2008 through 31 December 2009 were identified (N = 324). A follow-up survey was mailed. Primary outcomes were treatment failure, defined as International Consultation on Incontinence Questionnaire (ICIQ) score >0 or additional anti-incontinence procedure, and stress-specific incontinence (SSI). Secondary outcomes included Patient Global Impression of Severity and Improvement (PGI-SI), satisfaction, de novo urge, and complications. RESULTS: The study included 202 women who returned the survey. The SIMS group had higher body mass index (BMI) (30.7 ± 6.5 vs 28.9 ± 6.0 kg/m(2), P = 0.052) and shorter follow-up (18.6 ± 11.5 vs 22.9 ± 14.6 months, P = 0.019). Treatment failure was higher in SIMS compared with RMUS (76.3 % vs 64.2 %) with adjusted odds ratio of 1.84 (95 % CI, 1.0, 3.5). The SIMS group was more likely to have postoperative SSI, with adjusted OR of 2.4 (95 % CI; 1.3-4.5). The RMUS group reported more improvement and satisfaction. Incidence of de novo urge and complications were similar between groups. Reoperation for mesh erosion was more likely in the RMUS group, while the SIMS had a higher reoperation rate for SUI. CONCLUSIONS: Compared with retropubic ALIGN® Slings, MiniArc® Single-Incision Slings are less effective, with more postoperative incontinence, less patient-reported improvement, satisfaction, and higher reoperation rates for SUI.

Incidence of female urethral diverticulum: a population-based analysis and literature review.

INTRODUCTION AND HYPOTHESIS: Urethral diverticulum (UD) is a protrusion of the urethra through the periurethral fascia. We aimed to determine the population-based incidence of female UD. METHODS: Using the records-linkage system of the Rochester Epidemiology Project (REP), we identified women 18 years and older with a new diagnosis of UD in Olmsted County, Minnesota, USA, from 1 January 1980, through 31 December 2011. We also identified cases meeting the same criteria diagnosed at Mayo Clinic, regardless of county of residency. Incidence rates were calculated and trends for changes in incidence over time were tested. We conducted a systematic search of the MEDLINE, EMBASE, Cochrane Systematic Reviews, CENTRAL, Web of Science, and Scopus databases from inception through 30 March 2013, to identify published reports of UD incidence or prevalence. RESULTS: We identified 164 incidence cases, including 26 women residing in Olmsted County. Age-adjusted annual incidence of UD in Olmsted County was 17.9 per 1,000,000 women (<0.02 %) per year (95 % CI, 10.9-24.9). We observed a trend toward increased incidence during the past 3 decades (P = 0.03). In our literature review, only 7 studies included an estimate of incidence or prevalence of UD; these estimates ranged from 6.4 per 1,000,000 per year (<0.01 %) having surgical intervention related to UD to a 4.7 % rate of UD diagnosed in asymptomatic women admitted for gynecological or obstetric issues. CONCLUSIONS: In this population-based study, female UD was a rare disease, affecting fewer than 20 per 1,000,000 women (<0.02 %) per year.