Cost-Utility Analysis of Midurethral Sling Timing Among Women Undergoing Prolapse Surgery.

IMPORTANCE: There are no guidelines regarding the ideal timing of midurethral sling (MUS) placement following prolapse repair. OBJECTIVE: The objective of this study was to estimate the cost-utility of concomitant MUS versus staged MUS among women undergoing apical suspension surgery for pelvic organ prolapse. STUDY DESIGN: Cost-utility modeling using a decision analysis tree compared concomitant MUS with staged MUS over a 1-year time horizon. The primary outcome was the incremental cost-effectiveness ratio (ICER). Six scenarios were modeled to estimate cost-utilities for women with preoperative overt, occult, or no stress urinary incontinence (SUI) who underwent either minimally invasive sacrocolpopexy or vaginal native tissue apical suspension. Possible complications of de novo overactive bladder, urinary retention requiring sling lysis, mesh exposure, and persistent SUI were included. Costs from a third-party payer perspective were derived from Medicare 2022 reimbursements. One-way sensitivity analyses were performed. RESULTS: Among women without preoperative SUI, staged MUS was the dominant strategy for both surgical routes with higher utility and lower costs. For women with either occult or overt SUI undergoing sacrocolpopexy or vaginal repair, concomitant MUS was cost-effective (ICER = $21,114-$96,536 per quality-adjusted life-year). Therefore, concomitant MUS is preferred for patients with preoperative SUI as higher costs were offset by higher effectiveness. One-way sensitivity analyses demonstrated that ICERs were most affected by probability of cure following MUS. CONCLUSIONS: A staged MUS procedure is the dominant strategy for women undergoing apical prolapse repair without preoperative SUI. In women with either overt or occult SUI, the ICER was below the willingness-to-pay threshold of $100,000 per quality-adjusted life-year, suggesting that concomitant MUS surgery is cost-effective.

Surgical cost of robotic-assisted sacrocolpopexy: a comparison of two robotic platforms.

IMPORTANCE: Robotic assistance in pelvic organ prolapse surgery can improve surgeon ergonomics and instrument dexterity compared with traditional laparoscopy but at increased costs. OBJECTIVE: To compare total costs for robotic-assisted sacrocolpopexy (RSC) between two robotic platforms at an academic medical center. METHODS: Retrospective cohort of Senhance (Ascensus) RSC between 1/1/2019 and 6/30/21 who were matched 2:1 with DaVinci (Intuitive) RSC. Primary outcome was total costs to hospital system; secondarily we evaluated cost sub-categories. Purchase costs of the robotic systems were not included. T-test, chi-square, and Fisher's exact tests were used. A multivariable linear regression was performed to model total costs adjusting for potential confounders. RESULTS: The matched cohort included 75 subjects. The 25 Senhance and 50 DaVinci cases were similar overall, with mean age 60.5 ± 9.7, BMI 27.9 ± 4.7, and parity 2.5 ± 1.0. Majority were white (97.3%) and postmenopausal (86.5%) with predominantly stage III prolapse (64.9%). Senhance cases had longer OR times (Δ = 32.1 min, p = 0.01). There were no differences in concomitant procedures, intraoperative complications, or short-term postoperative complications between platforms (all p > 0.05). On univariable analysis, costs were similar (Senhance $5368.31 ± 1486.89, DaVinci $5741.76 ± 1197.20, p = 0.29). Cost subcategories (medications, supplies, etc.) were also similar (all p > 0.05). On multivariable linear regression, total cost was $908.33 lower for Senhance (p = 0.01) when adjusting for operative time, estimated blood loss, concomitant mid-urethral sling, and use of the GelPoint mini port system. CONCLUSIONS: Despite longer operating times, total cost of robotic-assisted sacrocolpopexy was significantly lower when using the Senhance compared to the DaVinci system.

Preprocedure and Immediate Postoperative Changes to Genital Hiatus Following Minimally Invasive Sacrocolpopexy.

IMPORTANCE: This study assesses resting genital hiatus (GH) measurements under anesthesia as compared with in-office measurements for intraoperative planning purposes. OBJECTIVES: The aim of this study was to determine the influence of general anesthesia and apical suspension on GH measurements compared with office measurements. STUDY DESIGN: This was a retrospective cohort of women who underwent minimally invasive sacrocolpopexy within an academic urogynecology practice. Genital hiatus for each patient was measured at 4 time points: (1) preoperative office examination (baseline) at rest (GH rest ) and with strain (GH strain ); (2) following anesthesia induction, at rest (GH induction ); (3) immediately after sacrocolpopexy, at rest (GH colpopexy ); and (4) 4- to 6-week postoperative visit, strain (GH postop ). Enlarged baseline GH strain was defined as ≥4 cm. Paired statistics and analysis of variance were used for comparisons. RESULTS: Fifty-one women were included, whose mean age was 61.3 ± 8.2 years; the majority had stage ≥3 prolapse (n = 39 [76.4%]). Concomitant procedures included hysterectomy (n = 33 [64.7%]) and posterior colporrhaphy or perineorrhaphy (n = 8 [15.7%]). The majority had an enlarged baseline GH strain (n = 39 [76.4%]), and overall cohort mean was 4.7 ± 1.3 cm. Compared with baseline GH rest , mean GH induction was larger (GH induction : 4.6 ± 1.4 cm vs GH rest : 3.8 ± 1.2 cm, P < 0.01) but not different from baseline GH strain (GH induction : 4.6 ± 1.4 cm vs GH strain : 4.7 ± 1.3 cm, P = 0.81). GH colpopexy was decreased from baseline GH strain with a mean difference of 1.1 ± 1.3 cm ( P < 0.01). This difference was driven by women with enlarged baseline GH strain who experienced a mean decrease of 1.5 ± 1.1 cm ( P < 0.01). CONCLUSIONS: Genital hiatus after induction of anesthesia does not significantly differ from preoperative straining GH. Apical suspension with sacrocolpopexy alone resulted in immediate reduction in GH measures, with greater decreases observed in women with enlarged preoperative GH.

Complications Reported to the Food and Drug Administration: A Cross-sectional Comparison of Urogynecologic Meshes.

IMPORTANCE: The U.S. Food and Drug Administration uses the Manufacturer and User Facility Device Experience database to evaluate the safety of urogynecologic meshes; however, reports on individual meshes have not been characterized. OBJECTIVE: The aim of the study was to compare complications among available urogynecologic meshes reported to the Manufacturer and User Facility Device Experience database. STUDY DESIGN: This study is a cross-sectional analysis of medical device reports (MDRs) of urogynecologic mesh from January 2004 to March 2019, using the Reed Tech Navigator (LexisNexis), which codes MDRs. The percentage of reports containing specific complaints (not an adverse event rate) were compared with χ 2 tests with Dunn-Sidak correction. Correlations with time on market, mesh weight, stiffness, and porosity were determined. RESULTS: The 34,485 reports examined included 6 transvaginal meshes, 4 sacrocolpopexy meshes, and 10 midurethral slings. Most reported events were pain, erosion, and infection. For transvaginal prolapse, less than 10% of Uphold Lite (Boston Scientific) reports contained pain or erosion versus greater than 90% of Prolift/Prolift+M (Ethicon, P < 0.001). For sacrocolpopexy mesh, greater than 90% of Gynemesh (Ethicon; Prolift in vaginal form) reports included erosion and pain versus less than 60% for Artisyn (Ethicon), Restorelle (Colpoplast), and Upsylon (Boston Scientific, P < 0.0001). For slings, Gynecare TVT Obturator had the highest proportion of erosion and pain complaints. Heavier sling meshes had more reports. When Ascend (Caldera Medical), an outlier with only 5 reports, was excluded, transvaginal mesh stiffness correlated strongly with number of reports. For transvaginal meshes, number of reports correlated with time on market (ρ = 0.8, P = 0.04). CONCLUSIONS: Individual meshes have different properties with different complication profiles, which should inform mesh development and use. Gynemesh MDRs included pain and erosion more frequently than others. Comprehensive registries are needed.

Sacrocolpopexy experience with a novel robotic surgical platform.

INTRODUCTION AND HYPOTHESIS: The objective was to describe early experience performing sacrocolpopexy using a novel robotic surgical platform. METHODS: This is a case series of all women who underwent robotic-assisted sacrocolpopexy using a new robotics platform (TransEnterix Senhance) between January 2019 and July 2021. All sacrocolpopexies were performed by a single Female Pelvic Medicine and Reconstructive surgeon at a large academic institution. Perioperative information including complications was abstracted from the medical record. Anatomical recurrence was defined as any anatomical point at or past the hymen (≥0). Data are descriptive, with Mann-Whitney U test used for comparison of operative time between the first and second half of the patients. RESULTS: A total of 25 sacrocolpopexies were performed using the new robotics platform. Mean age was 62.3 years (±9.2) and mean BMI was 26.5 (±3.8). Ten (40.0%) patients had a prior hysterectomy. Most (n = 21, 84.0%) had stage III or IV prolapse preoperatively. Mean operative time was 210.2 min (±48.6) and median estimated blood loss was 35 ml (IQR 25-50). Mean operative time decreased between the first and second half of the patients (231.7 min vs 190.3 min, p = 0.047). There were no major intraoperative complications. Median follow-up time was 16 weeks (IQR 4-34) and there were no subjective recurrences or retreatments during this period. Two patients (8.0%) had anatomical recurrence without subjective bother. There were two postoperative readmissions (8.0%) within 30 days for small bowel obstruction, one treated surgically and the other with nonsurgical management. CONCLUSIONS: Our case series demonstrates feasibility and successful early adoption of a new robotics platform for robotic sacrocolpopexy.

Patient Preparedness for Pelvic Organ Prolapse Surgery: A Randomized Equivalence Trial of Preoperative Counseling.

OBJECTIVE: Preoperative counseling can affect postoperative outcomes and satisfaction. We hypothesized that patient preparedness would be equivalent after preoperative counseling phone calls versus preoperative counseling office visits before prolapse surgery. METHODS: This was an equivalence randomized controlled trial of women undergoing pelvic organ prolapse surgery. Participants were randomized to receive standardized counseling via a preoperative phone call or office visit. The primary outcome was patient preparedness measured on a 5-point Likert scale by the Patient Preparedness Questionnaire at the postoperative visit. A predetermined equivalence margin of 20% was used. Two 1-sided tests for equivalence were used for the primary outcome. RESULTS: We randomized 120 women. The study was concluded early because of COVID-19 and subsequent surgery cancellations. There were 85 participants with primary outcome data (43 offices, 42 phones). Mean age was 62.0 years (±1.0) and 64 (75.3%) had stage III or stage IV prolapse. The primary outcome, patient preparedness measured at the postoperative visit, was equivalent between groups (office, n = 43 [97.7%]; phone, n = 42 [97.6%], P < 0.001). Most women reported they would have preferred a phone call (n = 66, 65.5%) with more women in the phone group expressing this preference than the office group (office 40.5% vs phone 90.5%, P < 0.001). Ultimately, nearly all women (96.5%) were satisfied with their method of counseling. CONCLUSIONS: Preoperative counseling phone calls were equivalent to office visits for patient preparedness for pelvic organ prolapse surgery. This study demonstrates patient acceptance of phone calls for preoperative counseling. Telehealth modalities should be considered as an option for preoperative patient counseling.

Preoperative Counseling Method and Postoperative Opioid Usage: A Secondary Analysis of the PREOP Study.

OBJECTIVE: The purpose of this analysis is to determine if postoperative opioid usage differs among women randomized to office or phone preoperative counseling for pelvic organ prolapse surgery. METHODS: This was a planned exploratory analysis of the Patient Preparedness for Pelvic Organ Prolapse Surgery study, which randomized women to standardized preoperative counseling by office visit or phone call before prolapse surgery. Inclusion criteria were the completion of the assigned counseling intervention and submission of a 7-day postoperative pain and medication diary. Multivariable logistic regression was done to assess the association between counseling method and total opioid use while controlling for variables significant on univariate analysis (surgery type and county of residence). RESULTS: There were 84 participants with postoperative data (41 office, 43 phone). Median total number of 5-mg oxycodone tablets used was higher for the office group (5 [interquartile range, 0-10]) than the phone group (0 [interquartile range, 0-2], P = 0.002). On multivariable logistic regression, women who underwent phone counseling were less likely to be in the highest third of opioid use when controlling for surgery type and county of residence (odds ratio, 0.23; P = 0.012; 95% confidence interval, 0.07-0.72). Daily pain scores and nonopioid medication use (nonsteroidal anti-inflammatory medications and acetaminophen) were similar between groups (P > 0.05). CONCLUSIONS: Despite similar pain scores, women who received preoperative phone counseling before pelvic organ prolapse surgery had lower opioid utilization than those with office counseling. Further research is needed to determine the optimal method of preoperative counseling and its role in postoperative pain management.

Temporal Trends of Urogynecologic Mesh Reports to the U.S. Food and Drug Administration.

OBJECTIVE: To compare temporal trends of urogynecologic mesh medical device reports with sentinel U.S. Food and Drug Administration (FDA) notices and to examine all linked reports of patient death. METHODS: The Reed Tech Navigator is an online tool used to extract and analyze data in the Manufacturer and User Facility Device Experience database. We used FDA product codes to search for reports of synthetic mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Reports with "death" listed as a patient event were queried further. RESULTS: There were 43,970 medical device reports involving urogynecologic mesh reported to the FDA between August 2000 and January 2019, with most occurring after the 2011 FDA communication (n=43,018, 97.8%). Of these medical device reports, 64.6% (n=28,422) were for SUI products, 27.0% (n=11,876) were for transvaginal POP products, and 8.4% (n=3,672) were for transabdominal POP products. Peak reporting occurred in 2013, which corresponded with the first major plaintiff verdicts and class action vaginal mesh settlement. There were 645 (1.5%) medical device reports of death, with 49.3% (n=318) having no cause of death identified. Only four (0.6%) could be directly attributed to the initial surgery. CONCLUSION: Since 2011, urogynecologic mesh has been the focus of thousands of medical device reports annually, although the data submitted are often incomplete. Few reported deaths are directly attributable to mesh products, and the majority lack sufficient information to draw causal conclusions. A high-quality registry is necessary to improve our understanding of the patient effect from urogynecologic mesh products.

Prolapse Recurrence After Sacrocolpopexy Mesh Removal: A Retrospective Cohort Study.

OBJECTIVES: There is limited literature regarding outcomes after sacrocolpopexy mesh removal. We sought to compare the proportion of prolapse recurrence in women after sacrocolpopexy mesh removal with women who underwent sacrocolpopexy without subsequent mesh removal. We hypothesize that more women will experience prolapse recurrence after mesh removal. METHODS: This is a retrospective cohort study of women who underwent sacrocolpopexy mesh removal between 2010 and 2019. These patients were time matched with women who had a sacrocolpopexy but did not undergo mesh removal. Prolapse recurrence was defined as the leading edge past the hymen or retreatment. Analysis was done using χ, Wilcoxon rank-sum, or t test with a Cox proportional hazard model to assess the association between mesh removal and time to recurrence. RESULTS: We identified 26 mesh removals, which were matched with 78 patients without mesh removal. The most common indications for mesh removal were exposure (69.2%) and pain (57.7%). Women who underwent mesh removal were more likely to have Mersilene mesh (19.2% vs 1.3%, P = 0.006). Recurrence occurred in 46% of women who had mesh removal compared with 7.7% in those without (P < 0.001). When adjusted for age, parity, menopause, smoking, and diabetes status, those who had mesh removal had a 15 times higher hazard of prolapse recurrence (adjusted hazard ratio = 15.4, 95% confidence interval = 4.3-54.8, P = <.0001). CONCLUSIONS: When compared with time-matched controls, women who underwent sacrocolpopexy mesh removal had a significantly higher proportion of prolapse recurrence. Prospective studies are needed to further explore the utility of concomitant prolapse repair at the time of mesh removal.

Variables associated with an inability to learn clean intermittent self-catheterization after urogynecologic surgery.

INTRODUCTION AND HYPOTHESIS: Post-operative urinary retention is a common problem affecting close to half of all women undergoing pelvic reconstructive surgery. This was an exploratory analysis that was aimed at identifying factors associated with an inability to learn clean intermittent self-catheterization (CISC) after a failed post-operative retrograde voiding trial (RGVT). METHODS: We performed a retrospective case-control study of women who underwent pelvic organ prolapse or urinary incontinence surgery within a single division from 2016 to 2018. We compared women who could learn CISC with those unable to learn and discharged home with an indwelling catheter (IC). Analyses were carried out using Fisher's exact test, the Mann-Whitney U test, the Chi-squared test, and the t test with logistic regression. RESULTS: Of the 202 women who failed their RGVT, 134 (66.3%) were able to learn CISC and 68 (33.7%) were not. Older age, urinary incontinence, diabetes and colpectomy/colpocleisis were associated with an inability to learn CISC (p < 0.05). Women with an IC were more likely to have an office visit related to catheter care (65.7% vs 5.2%, p < 0.001). A UTI within 30 days of surgery was more common with CISC (16.4% vs 6.0%, p = 0.037). In a multivariate logistic regression model, each increasing year of age was associated with a 1.036-fold decrease in the ability to learn CISC (aOR 1.036, 95% CI 1.002-1.071; p = 0.04). CONCLUSIONS: Increasing age was the only variable identified on multivariate logistic regression as a risk factor for failure to learn CISC. Further studies are needed to identify barriers to learning post-operative self-catheterization.

Impact of treatment for fecal incontinence on constipation symptoms.

OBJECTIVE: Defecatory symptoms, such as a sense of incomplete emptying and straining with bowel movements, are paradoxically present in women with fecal incontinence. Treatments for fecal incontinence, such as loperamide and biofeedback, can worsen or improve defecatory symptoms, respectively. The primary aim of this study was to compare changes in constipation symptoms in women undergoing treatment for fecal incontinence with education only, loperamide, anal muscle exercises with biofeedback or both loperamide and biofeedback. Our secondary aim was to compare changes in constipation symptoms among responders and nonresponders to fecal incontinence treatment. STUDY DESIGN: This was a planned secondary analysis of a randomized controlled trial comparing 2 first-line therapies for fecal incontinence in a 2 × 2 factorial design. Women with at least monthly fecal incontinence and normal stool consistency were randomized to 4 groups: (1) oral placebo plus education only, (2) oral loperamide plus education only, (3) placebo plus anorectal manometry-assisted biofeedback, and (4) loperamide plus biofeedback. Defecatory symptoms were measured using the Patient Assessment of Constipation Symptoms questionnaire at baseline, 12 weeks, and 24 weeks. The Patient Assessment of Constipation Symptoms consists of 12 items that contribute to a global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps). Scores for each subscale as well as the global score range from 0 (no symptoms) to 4 (maximum score), with negative change scores representing improvement in defecatory symptoms. Responders to fecal incontinence treatment were defined as women with a minimally important clinical improvement of ≥5 points on the St Mark's (Vaizey) scale between baseline and 24 weeks. Intent-to-treat analysis was performed using a longitudinal mixed model, controlling for baseline scores, to estimate changes in Patient Assessment of Constipation Symptoms scores from baseline through 24 weeks. RESULTS: At 24 weeks, there were small changes in Patient Assessment of Constipation Symptoms global scores in all 4 groups: oral placebo plus education (-0.3; 95% confidence interval, -0.5 to -0.1), loperamide plus education (-0.1, 95% confidence interval, -0.3 to0.0), oral placebo plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2), and loperamide plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2). No differences were observed in change in Patient Assessment of Constipation Symptoms scores between women randomized to placebo plus education and those randomized to loperamide plus education (P = .17) or placebo plus biofeedback (P = .82). Change in Patient Assessment of Constipation Symptoms scores in women randomized to combination loperamide plus biofeedback therapy was not different from that of women randomized to treatment with loperamide or biofeedback alone. Responders had greater improvement in Patient Assessment of Constipation Symptoms scores than nonresponders (-0.4; 95% confidence interval, -0.5 to -0.3 vs -0.2; 95% confidence interval, -0.3 to -0.0, P < .01, mean difference, 0.2, 95% confidence interval, 0.1-0.4). CONCLUSION: Change in constipation symptoms following treatment of fecal incontinence in women are small and are not significantly different between groups. Loperamide treatment for fecal incontinence does not worsen constipation symptoms among women with normal consistency stool. Women with clinically significant improvement in fecal incontinence symptoms report greater improvement in constipation symptoms.

Bowel preparation prior to minimally invasive sacrocolpopexy: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The objective was to determine if a bowel preparation prior to minimally invasive sacrocolpopexy (MIS) influences post-operative constipation symptoms. We hypothesized that women who underwent a bowel preparation would have an improvement in post-operative defecatory function. METHODS: In this randomized controlled trial, women undergoing MIS received a pre-operative bowel preparation or no bowel preparation. Our primary outcome was post-operative constipation measured by the Patient Assessment of Constipation Symptoms (PAC-SYM) 2 weeks post-operatively. Secondary outcomes included surgeon's perception of case difficulty. Both intention-to-treat (ITT) and per-protocol analyses (PPA) were performed. Analyses were carried out using t test, Fisher's exact test, the Wilcoxon test and the Chi-squared test. RESULTS: Of 105 enrolled women, 95 completed follow-up (43 preparation and 52 no preparation). Baseline characteristics and rates of complications were similar. No differences were noted on ITT. The post-operative abdominal PAC-SYM subscale was closer to baseline for women who received a bowel preparation on PPA (change in score 0.74 vs 1.08, p = 0.045). Women who underwent a preparation were less likely to report strain (6.0% vs 26.7%, p = 0.009) or type 1 Bristol stool on their first post-operative bowel movement (4.3% vs 17.5%, p = 0.047). Surgeons were more likely to rate the complexity of the case as "more difficult than average" (54.4% vs 40.1%, p = 0.027) in those without a bowel preparation. CONCLUSIONS: Although there was no difference in ITT analysis, women who underwent a bowel preparation prior to MIS demonstrated benefit to post-operative defecatory function with a corresponding improvement in surgeon's perception of case complexity.

HIV testing among sexually experienced Asian and Pacific Islander young women association with routine gynecologic care.

PURPOSE: To describe the proportion of HIV testing in the past 12 months among sexually experienced Asian and Pacific Islander (API) women and to investigate to what extent routine gynecologic care (RGC) increases HIV testing among API women. METHODS: Data were derived from Wave III of the National Longitudinal Study of Adolescent Health (Add Health). Analyses were limited to 7,576 sexually experienced women (White, n = 4,482 [68.5%]; Black, n = 1,693 [25.6%]; Hispanic, n = 923 [13.9%]; API, n = 478 [7.2%]) aged 18-27 years. Multiple logistic regression analyses were used to estimate the association between RGC and HIV testing after controlling for predisposing, need, and enabling factors. FINDINGS: On average, 22.8% (n = 1,504) of sexually experienced women reported HIV testing in the past year. API women had the lowest proportion of testing (17.2%), and Black women had the highest (26.2%). Overall, 60.2% of API women reported receiving RGC; however, only 15.5% of API who received RGC reported HIV testing. After controlling for covariates, significantly positive associations were found for White, Black, and Hispanic women between RGC and HIV testing; however, there was no evidence that RGC was associated with HIV testing among API women. CONCLUSION: Our data suggest that RGC does not [corrected] increase HIV testing among API women. To eliminate disparities in HIV testing service utilization among API women, appropriate efforts should be directed to better understand the barriers and facilitators of HIV testing among this population.