The Patient Acceptable Symptom State in Female Urinary Incontinence.

OBJECTIVE: The objective of this study is to characterize an acceptable health state, using the patient acceptable symptom state (PASS) question, in adult women with urinary incontinence. METHODS: This is a prospective multicenter cohort study determining PASS thresholds from condition-specific measures using an electronic research platform in English-speaking women seeking nonsurgical treatment of urinary incontinence between March 2019 and May 2020. Exclusions included pregnancy, isolated overactive bladder, and pelvic organ prolapse greater than stage II. The cohort was described and then grouped based on achievement of PASS. The PASS thresholds were determined using the 75th percentile and univariate regression methods. Multivariable regression modeling was used to understand the influence of covariates on PASS achievement. RESULTS: The study was completed by 100 (80%) of the 125 enrolled subjects. Of these, 45% (n = 45) achieved PASS after a median of 7 weeks of treatment (range, 6-13 weeks). The corresponding questionnaire score for PASS was estimated to be 6 for the Incontinence Severity Index, 3 for the Patient Global Impression of Severity and Improvement, 37.5 using the Urinary Distress Inventory 6, and 33.3 using the Incontinence Impact Questionnaire 7. Increasing age was independently associated with achieving PASS after adjusting for treatment adherence and outcomes scores (adjusted odds ratio, 1.05 [95% confidence interval, 1.01-1.10]; P = 0.02). CONCLUSIONS: PASS was achieved in 45% of women after conservative treatment of urinary incontinence. PASS offers a new perspective for analysis and interpretation of outcome measures used in pelvic floor disorders and can serve as a reference for future research and clinical care pathways.

Robotic hysterectomy compared with laparoscopic hysterectomy: is it still more costly to perform?

To establish the economic value of simple robotic hysterectomy vs laparoscopic hysterectomy and assess the impact of surgeon's experience. Retrospective cohort study. University-affiliated US regional healthcare system. Reproductive and post-menopausal women undergoing hysterectomy for benign indications. Robotic or laparoscopic hysterectomy. Between January 2018 and December 2019, a total of 985 simple laparoscopic and robotic hysterectomies were performed by 47 different gynecologists. Overall, the mean payment, direct cost, and profit were comparable (p value > 0.05) among simple robotic and laparoscopic hysterectomy. However, the mean operative time was significantly shorter for robotic hysterectomy compared to laparoscopic hysterectomy (106 min vs 127 min, respectively, p < 0.05). Operative time decreased as a surgeon's annual robotic case volume increased. Per-minute profitability of robotic hysterectomy increased significantly when a surgeon performed greater than 45 cases annually (p = 0.04). This effect became most pronounced when a surgeon performed 60 or more cases per year (p = 0.01). Simple robotic hysterectomy has shorter operative time compared to laparoscopic hysterectomy, with direct costs being similar. Robotic hysterectomy has higher per-minute profit compared to laparoscopic hysterectomy when a surgeon performs > 45 cases per year.

Sacral neuromodulation for symptomatic chronic urinary retention in females: do age and comorbidities make a difference?

OBJECTIVES: To evaluate if age and medical comorbidities are associated with progression to implantation of sacral neuromodulation devices in women with symptomatic chronic urinary retention. METHODS: This multisite retrospective cohort included women with symptomatic chronic urinary retention who had a trial phase of sacral neuromodulation. The primary outcome was progression to implantation. Post-implantation outcomes were assessed as stable response versus decreased efficacy. A sub-analysis of catheter-reliant (intermittent-self catheterization or indwelling) patients was performed. Age was analyzed by 10-year units (decades of age). Multivariate logistic regression determined odds ratios for outcomes of implantation and for post-implantation stable response. RESULTS: Implantation occurred in 86% (243/284) women across six academic institutions. Most patients (160/243, 66%) were catheter reliant at the time of trial phase. Increased decade of age was associated with reduced implantation in all women [OR 0.54 (95% CI 0.42, 0.70)] and in the subgroup of catheter-reliant women [OR 0.52 (95% CI 0.37, 0.73)]. Post-implantation stable response occurred in 68% (193/243) of women at median follow-up of 2 years (range 0.3-15 years). Medical comorbidities present at the time of trials did not impact progression to implantation or post-implantation success. CONCLUSIONS: Increasing decade of age is associated with reduced implantation in women with symptomatic chronic urinary retention. There is no age cutoff at which outcomes change. Post-implantation stable response was not associated with age or medical comorbidities.

Risk Factors for Polypropylene Midurethral Sling Extrusion: A Case-Control Study.

OBJECTIVE: To identify risk factors associated with surgical revision of midurethral sling (MUS) due to mesh extrusion. MATERIALD AND METHODS: This is a case-control study identifying women who underwent primary surgical revision of polypropylene MUS for vaginal mesh extrusion from 2001 to 2016. Cases of surgical revision were compared to a randomly selected control group in a 1:5 ratio. Patient demographics and clinical characteristics were compared and multivariate logistic regression modeling was performed to analyze the relationships between risk factors and vaginal mesh extrusion. RESULTS: In total, 64 cases were identified and compared to 400 controls. The average subject was 51.7 years old (range, 30-78) with a body mass index (BMI) of 27.9 kg/m2 (range, 23.6-30.2) at the time of surgical revision. The median time to MUS revision was 318 days (interquartile range, 144-1355 days). Surgical revision was associated with current smokers (odds ratio [OR] = 5.43 [95% confidence interval [CI] 2.86, 10.31]), a BMI under 30 kg/m2 (OR = 4.37 [95% CI = 2.05, 9.36]), age under 55 years (OR = 2.02, [95% CI = 1.13, 3.61]), a retropubic sling (OR = 2.10 [95% CI = 1.14, 3.88]), and fibromyalgia (OR = 3.33 [95% CI 1.12, 9.95]). CONCLUSION: Smoking status, age under 55 years, BMI below 30 kg/m2, fibromyalgia, and retropubic approach were factors associated with surgical revision of MUS due to vaginal mesh extrusion. These findings may improve counseling and patient selection.

Sacral neuromodulation for overactive bladder in women: do age and comorbidities make a difference?

OBJECTIVE: To evaluate if age and comorbidities are associated with progression from trial phase to implantation of an implantable pulse generator in women with overactive bladder. METHODS: This multisite retrospective cohort included women with overactive bladder with or without urinary incontinence who had a trial phase for sacral neuromodulation. The primary outcome was progression to implantation. A sub-analysis of implanted patients was performed for the outcome of additional therapies or "implant only" for the duration of follow-up. Multivariate logistic regression models including potential predictors of implantation and post-implantation addition of therapies were performed. RESULTS: At six academic institutions, 91% (785/864) of patients progressed to implantation. Post-implantation success was achieved by 69% (536/782) of patients at median follow-up of 2 (range 0.3 to 15) years. Odds of implantation [OR 0.73 (CI 0.61, 0.88)] and post-implantation success [OR 0.78 (CI 0.98, 0.97)] were lower with increasing decades of age. Medical comorbidities evaluated did not affect implantation rates or post-implant success. CONCLUSIONS: Most women have successful sacral neuromodulation trials despite older age and comorbidities. Higher decade of age has a negative effect on odds of implantation and is associated with addition of therapies post-implantation. Comorbidities assessed in this study did not affect implantation or addition of therapies post-implantation. Most women add therapies to improve efficacy post-implantation, and explantation rates are low.

Improvements in Self-Reported Depression Following Treatment of Fecal Incontinence with Sacral Neuromodulation.

OBJECTIVE: To evaluate changes in self-reported depression after treatment of fecal incontinence (FI) with sacral neuromodulation. MATERIALS AND METHODS: This is a subanalysis of data collected from March 2016 to October 2017 for an Institutional Review Board-approved retrospective cohort study. Demographic information, medical history, psychiatric comorbidities, and the Patient-Reported Outcomes Measurement Information System item bank t-scores were extracted from the electronic medical record. The differences in t-scores were compared with a two-sided paired t-test, and a p value <0.05 was considered statistically significant. RESULTS: Of the cohort (n = 24), most were Caucasian (88%), female (92%), nonsmokers (92%). Median age was 63.5 years (interquartile range 57.5-71.0 years) and median body mass index was 27.7 kg/m2 (range 18.3-42.9 kg/m2 ). A significant decrease in mean depression t-scores occurred after implantation of a sacral neuromodulation device, -4.5 (95% confidence interval [CI]: -8.7, -0.2, p = 0.04). Self-reported pain interference (p = 0.37) and physical function (p = 0.47) scores were similar following implantation. Individuals with comorbid anxiety reported the greatest improvement in depression (-6.5, 95% CI: -11.8, -1.1, p = 0.02). CONCLUSIONS: Treatment of FI with sacral neuromodulation was associated with improvement in self-reported depression with the greatest improvement in those with anxiety. Further prospective research is needed to corroborate these findings.

Sleep disturbance changes in women after treatment of refractory overactive bladder with sacral neuromodulation.

Purpose: The aim of this study is to evaluate changes in sleep disturbance following treatment of overactive bladder with sacral neuromodulation. Materials and Methods: This is a sub-analysis of data collected from an institutional review board approved retrospective cohort study evaluating women with Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) before and after sacral neuromodulation for overactive bladder between March 2016 and October 2017. Data collected included demographics, clinical characteristics, and additional PROMIS item banks. Within-group analysis was performed with paired t-tests. Groups based up on PROMIS-SD improvement (change <0) were then compared using Fisher's exact test, t-test, or Mann-Whitney U-test as appropriate. Results: Those with improved sleep disturbance (n=7) noted a significant mean improvement of -3.99 (95% confidence interval, -6.32, -1.65; p<0.01). Both pre- and post-procedure PROMIS-Physical Function (38.86±2.35 vs. 34.13±5.58, p=0.07 and 37.14±5.10 vs. 35.44±4.74, p=0.53), Pain Interference (60.04±6.34 vs. 65.50±6.20, p=0.13 and 57.89±5.08 vs. 64.73±7.35, p=0.07), Depression (44.2±4.73 vs. 61.29±9.53, p=0.17 and 54.29±6.25 vs. 57.96±11.42, p=0.47) t-scores were similar between sleep response groups. Conclusions: Those with improved sleep disturbance reported significant changes after sacral neuromodulation for overactive bladder. However, no significant differences were identified between those with and without improvement. Further investigation of changes in sleep disturbance and factors affecting change are needed within this population.

Evaluation of Sacral Nerve Stimulation Device Revision and Explantation in a Single Center, Multidisciplinary Study.

OBJECTIVE: This study aimed to determine the incidence and risk factors associated with revision or removal of a sacral nerve stimulation device for treatment of lower urinary tract dysfunction or fecal incontinence. MATERIALS AND METHODS: This is a single-center multidisciplinary retrospective cohort study conducted at a university hospital from January 2013 through October 2017. Subjects who underwent successful sacral neuromodulation were identified via procedural codes. Clinical and demographic data regarding device revision or removal were extracted from the medical record. When testing differences between groups, t-test or Mann-Whitney U test was used to compare continuous variables. Categorical variables were compared by Chi-square test. Risk factors with a p value <0.2 in univariate investigation were included in the multivariate analysis. Logistic regression modeling was used to compare associations between risk factors and re-operation rates. RESULTS: Of the 219 subjects analyzed, 35 (16%) had revision or explantation of the sacral nerve stimulation device. Median time to re-operation was 164 days (interquartile range [IQR]: 29, 525). Subjects with device revised or explanted were younger, with a median age of 50 years vs. 62 years (p < 0.01) for those who did not undergo explantation. Patient demographics and co-morbidities were otherwise similar. Multivariate analysis identified age under 55 years (odds ratio [OR]: 2.51; 95% confidence interval [CI]: 1.18-5.33) as a significant risk factor. Our regression model showed that neither preimplantation diagnosis of chronic pain (OR: 0.60; 95% CI: 0.28-1.27) nor the specialty of the surgeon (OR 1.04; 95% CI 0.66-1.62) was associated with stimulation device revision or explantation. CONCLUSIONS: This study found a 16% incidence of revision or explantation. Age under 55 years was identified as a significant risk factor. Our analysis did not find further demographic characteristics, co-morbid disorders, or behavioral diagnoses that were associated with revision or removal. Identification of risk factors may aid in patient selection for sacral nerve stimulation device implantation.

Manual morcellation compared to power morcellation during robotic myomectomy.

Clinical practice has drastically changed following the 2014 U.S. Food and Drug Administration (FDA) warning statement regarding power morcellation during laparoscopic hysterectomy and myomectomy. Despite investigation into alternative tissue extraction techniques, there remain a paucity of data associated with contained manual morcellation techniques. The goal of this study was to investigate the associated perioperative outcomes of contained manual morcellation compared to power morcellation in women undergoing robotic myomectomy. Performing manual morcellation (n = 38) resulted in a 21-min decrease in mean operative time (105.4 ± 42.2 vs 126.1 ± 44.1 min, p = 0.02) compared to power morcellation (n = 62). Women were younger (33 vs 36 years, p = 0.03) in the manual morcellation group, with all other patient demographics being similar. Median specimen weight (82 vs 104 g, p = 0.13), number of fibroids removed (2 vs 1, p = 0.16), estimated blood loss (10 vs 50 mL, p = 0.25), and post-operative morphine equivalents administered (5.57 ± 4.57 vs 5.29 ± 4.39, p = 0.76) were similar. The same-day discharge rate was not significantly different between the groups (86 vs 90%, p = 0.74). Linear regression modeling identified specimen weight, number of fibroids removed, and use of power morcellation as significant contributors to surgical time. Contained manual morcellation during robotic myomectomy is associated with a significant decrease in surgical time when compared to power morcellation, with similar post-operative narcotic administration and length of stay.

Robotic Repair of Supratrigonal Vesicovaginal Fistula with Sigmoid Epiploica Interposition.

INTRODUCTION AND HYPOTHESIS: In the United States, vesicovaginal fistula (VVF) most often results from gynecologic surgery causing significant morbidity and distress to both the patient and surgeon. The use of tissue interposition at time of primary repair has been advocated to decrease the risk of recurrence. The aim of this study is to describe our experience with interposition of sigmoid epiploica during robotic extravesical repair of supratrigonal VVF. METHODS: This is a retrospective case series from June 2015 to September 2016. Features of the surgical technique include 1) cystoscopic ureteral catheterization, 2) cannulation of the fistula, 3) mobilization of the bladder from the vagina, 4) removal of the epithelialized edges of the fistulous tract, 5) single-layer closure of the vagina, 6) tension-free layered closure of the bladder, 7) retrograde fill of the bladder to ensure water-tight repair, 8) interposition of sigmoid epiploica appendage(s), and 9) prolonged bladder drainage with indwelling transurethral catheter. RESULTS: In total, 5 women underwent successful robotic VVF repair with epiploic appendage interposition. Mean surgical time was 218 minutes with an average console time of 147 minutes and an estimated blood loss of 49 mL. Most the patients were discharged to home on postoperative day 1 with no untoward effects due to the epiploica interposition. There have been no recurrences to date. CONCLUSIONS: Robotic repair of VVF with sigmoid epiploica interposition is efficient and well tolerated. Use of this technique may increase the number of patients eligible for tissue interposition.

Bilateral obturator neuropathy after transobturator vaginal sling: a case report.

Transobturator tape procedure is a popular and effective minimally invasive technique to treat stress urinary incontinence. We report a case of transient obturator neuropathy caused by transobturator tape placement for stress urinary incontinence. Findings on physical examination were significant for bilateral obturator neuropathy resulting in significant motor deficit, prompting removal of the sling to avoid the potential of prolonged or permanent morbidity. There was immediate complete resolution of neuropathy with the return of motor function after surgical removal of the sling.