Healthcare Resource Utilization Following Minimally Invasive Sacrocolpopexy: Impact of Concomitant Rectopexy.

INTRODUCTION AND HYPOTHESIS: Combined surgical procedures with sacrocolpopexy (SCP) and rectopexy (RP) are more commonly being performed for treatment of multicompartment pelvic organ prolapse. This study aimed to compare healthcare resource utilization (HRU) within 6 weeks following combined surgery (SCP-RP) versus SCP alone (SCP-only). We hypothesized that concomitant RP does not impact HRU. METHODS: A retrospective cohort study of patients who underwent minimally invasive SCP from 2017 to 2022 was conducted at a tertiary referral center. Patients were grouped based on the performance of concomitant RP. HRU was defined as a composite of unscheduled office visits, emergency department visits, and readmissions before the 6-week postoperative visit. HRU was compared in the SCP-RP and SCP-only groups. Multivariable regression analysis was performed to identify factors associated with HRU. RESULTS: There were 144 patients in the SCP-RP group and 405 patients in the SCP-only group. Patient characteristics were similar between the two groups, with the following exceptions: the SCP-RP group was older, more likely to have comorbid conditions, and live >60 miles from the hospital. Of the 549 patients, 183 (33.3%) had ≥1 HRU encounter within 6 weeks after surgery. However, there was no difference between the SCP-RP and SCP-only groups in composite HRU (34.0% vs 33.1%, p = 0.84). The most common reasons for HRU were pain, urinary tract infection symptoms, and wound issues. Concomitant mid-urethral sling was associated with a two-fold increased risk of HRU after surgery. CONCLUSIONS: One in 3 patients undergoing minimally invasive SCP had at least one unanticipated encounter within 6 weeks after surgery. Concomitant RP was not associated with increased postoperative HRU.

Urethral Bulking With Polyacrylamide Hydrogel Compared With Other Treatments for Stress Urinary Incontinence: A Cost-Effectiveness Analysis.

Our objective was to perform a cost-effectiveness analysis comparing polyacrylamide hydrogel urethral bulking with other surgical and nonsurgical treatments for stress urinary incontinence (SUI). We created a cost-effectiveness analysis using TreeAge Pro, modeling eight SUI treatments. Treatment with midurethral sling (MUS) had the highest effectiveness (1.86 quality-adjusted life-years [QALYs]), followed by polyacrylamide hydrogel (1.82 QALYs), with a difference (Δ 0.02/year) less than the minimally important difference for utilities of 0.03 annually. When the proportion of polyacrylamide hydrogel urethral bulking procedures performed in the office setting is greater than 58%, polyacrylamide hydrogel is a cost-effective treatment for SUI, along with pessary, pelvic floor physical therapy, and MUS. Although MUS is more effective and, therefore, the preferred SUI treatment, polyacrylamide hydrogel is a reasonable alternative depending on patient preferences and treatment goals.

Vaginal hysteropexy compared with vaginal hysterectomy with apical suspension for the treatment of pelvic organ prolapse: A 5-year cost-effectiveness Markov model.

OBJECTIVE: Our objective was to perform a 5-year cost-effectiveness analysis of transvaginal hysteropexy (HP) via sacrospinous ligament fixation (SS) or uterosacral ligament suspension (US) versus vaginal hysterectomy (VH) with apical suspension via sacrospinous ligament fixation (SS) or uterosacral ligament suspension (US) for the treatment of uterine prolapse. DESIGN: A decision analytic model assessed the cost-effectiveness of the surgical intervention over a 5-year horizon. SETTING: This model was constructed using TreeAge® software. POPULATION OR SAMPLE: Healthy women undergoing surgery for uterine prolapse were modeled. METHODS: A Markov model was constructed to simulate the possible recurrence of prolapse. Recurrence rates, repeat surgery for surgical failures and complication rates were modeled. Base case, sensitivity analyses and probabilistic modeling were performed. MAIN OUTCOME MEASURES: The primary outcome was the incremental cost-effectiveness ratio (ICER) of <$100 000 per quality-adjusted life year (QALY). RESULTS: Using the available prolapse recurrence rates and repeat surgery rates in the literature, both HP-SS and HP-US are cost-effective at a willingness-to-pay (WTP) threshold of <$100 000 per QALY. The incremental cost-effectiveness ratio (ICER) for HP-US compared to HP-SS is $90 738.14, while VH-US and VH-SS are both dominated strategies. HP-US is the optimal cost-effective strategy but decays exponentially with increasing probability of prolapse recurrence and need for repeat surgery after failed hysteropexy. The cost-effectiveness acceptability curve (CEAC) favors sacrospinous hysteropexy until reaching a WTP threshold between $90 000 and $100 000. CONCLUSION: Hysteropexy surgical strategies are cost-effective transvaginal surgical approaches for uterine prolapse. Vaginal hysterectomy with apical suspension becomes more cost-effective with increasing probability of prolapse recurrence and need for repeat surgery after failed hysteropexy. Given the variability of prolapse recurrence rates in the literature, more comparative studies are needed to understand the cost-effectiveness relationship between these different surgical approaches.

Trends in Urogynecologic Surgery Among Obstetrics and Gynecology Residents From 2002 to 2022.

IMPORTANCE: The number of American women with a pelvic floor disorder is projected to increase from 28.1 million in 2010 to 43.8 million in 2050. OBJECTIVES: The objective of this study was to evaluate trends in the number of urogynecologic procedures performed by graduating obstetrics and gynecology residents and to compare variability in volume between residents in the 70th and 30th percentiles for logged cases. STUDY DESIGN: National case log measures for residents who graduated between 2003 and 2022 were reviewed. Mean case numbers and variability in case numbers were analyzed over time. RESULTS: Data were collected from a median of 1,216.5 residents (range, 1,090 to 1,427) annually. Mean number of vaginal hysterectomies logged per resident decreased by 46.4% from 2002/2003 to 2021/2022 ( P = 0.0007). Mean number of urogynecology procedures increased by 1,165.5% from 2002/2003 to 2007/2008 ( P = 0.0015). Mean number of incontinence and pelvic floor procedures (including cystoscopies) increased by 190.9% from 2002/2003 to 2011/2012 ( P = 0.0002). Mean number of incontinence and pelvic floor procedures (excluding cystoscopies) decreased by 39.7% from 2012/2013 to 2021/2022 ( P < 0.0001). Mean number of cystoscopies increased by 19.7% from 2012/2013 to 2021/2022 ( P < 0.0001). Ratios of cases logged by residents in the 70th percentile to those in the 30th percentile decreased for vaginal hysterectomies and cystoscopies ( P < 0.0001 and P = 0.0040, respectively). The ratio for incontinence and pelvic floor procedures (excluding cystoscopies) was 1.76 in 2012/2013 and 2.35 in 2021/2022 ( P = 0.2878). CONCLUSION: Resident surgical training in urogynecology is decreasing nationally.

Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial.

BACKGROUND: Opioids are routinely prescribed for postoperative pain control after gynecologic surgery with growing evidence showing that most prescribed opioids go unused. Restrictive opioid prescribing has been implemented in other surgical specialties to combat the risk for opioid misuse and diversion. The impact of this practice in the urogynecologic patient population is unknown. OBJECTIVE: This study aimed to determine if a restrictive opioid prescription protocol is noninferior to routine opioid prescribing in terms of patient satisfaction with pain control after minor and major surgeries for prolapse and incontinence. STUDY DESIGN: This was a single-center, randomized, noninferiority trial of opioid-naïve patients who underwent minor (eg, colporrhaphy or mid-urethral sling) or major (eg, vaginal or minimally invasive abdominal prolapse repair) urogynecologic surgery. Patients were excluded if they had contraindications to all multimodal analgesia and if they scored ≥30 on the Pain Catastrophizing Scale. Subjects were randomized on the day of surgery to the standard opioid prescription protocol (wherein patients routinely received an opioid prescription upon discharge [ie, 3-10 tablets of 5 mg oxycodone]) or to the restrictive protocol (no opioid prescription unless the patient requested one). All patients received multimodal pain medications. Participants and caregivers were not blinded. Subjects were asked to record their pain medication use and pain levels for 7 days. The primary outcome was satisfaction with pain control reported at the 6-week postoperative visit. We hypothesized that patient satisfaction with the restrictive protocol would be noninferior to those randomized to the standard protocol. The noninferiority margin was 15 percentage points. Pain level scores, opioid usage, opioid prescription refills, and healthcare use were secondary outcomes assessed for superiority. RESULTS: A total of 133 patients were randomized, and 127 (64 in the standard arm and 63 in the restrictive arm) completed the primary outcome evaluation and were included in the analysis. There were no statistically significant differences between the study groups, and this remained after adjusting for the surgery type. Major urogynecologic surgery was performed in 73.6% of the study population, and minor surgery was performed in 26.4% of the population. Same-day discharge occurred for 87.6% of all subjects. Patient satisfaction was 92.2% in the standard protocol arm and 92.1% in the restrictive protocol arm (difference, -0.1%; P=.004), which met the criterion for noninferiority. No opioid usage in the first 7 days after hospital discharge was reported by 48.4% of the patients in the standard protocol arm and by 70.8% in the restrictive protocol arm (P=.009). Opioid prescription refills occurred in 8.5% of patients with no difference between the study groups (9.4% in the standard arm vs 6.7% in the restrictive arm; P=.661). No difference was seen in the rate of telephone calls and urgent visits for pain control between the study arms. CONCLUSION: Among women who underwent minor and major surgery for prolapse and incontinence, patient satisfaction rates were noninferior after restrictive opioid prescribing when compared with routine opioid prescribing.

Patient Outcomes After Robotic Ventral Rectopexy With Sacrocolpopexy.

IMPORTANCE: As few studies exist examining postoperative functional outcomes in patients undergoing robotic sacrocolpopexy and ventral rectopexy, results from this study can help guide surgeons in counseling patients on their outcomes. OBJECTIVE: The aim of the study was to evaluate functional outcomes and overall postoperative satisfaction as measured by the Pelvic Floor Disability Index 20 (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and Patient Global Impression of Improvement Scale (PGI-I) in patients who underwent combined robotic ventral rectopexy and sacrocolpopexy for concomitant pelvic organ prolapse (POP) and rectal prolapse or intussusception (RP/I). METHODS: This was a retrospective cohort and survey study of patients with combined POP and RP/I who underwent the previously mentioned surgical repair between January 2018 and July 2021. Each patient was contacted to participate in a survey evaluating postoperative symptoms related bother, sexual function, and overall satisfaction using the PFDI-20, PISQ-12, and PGI-I. RESULTS: A total of 107 patients met study inclusion criteria with 67 patients completing the surveys. The mean age and body mass index were 63.7 ± 11.5 years and 25.0 ± 5.4, respectively. Of the patients, 19% had a prior RP repair and 23% had a prior POP repair. Rectal prolapse or intussusception recurrence was reported in 10.4% of patients and objective POP recurrence was found in 7.5% of patients. Sixty-seven patients (62%) completed the surveys. The median time to survey follow-up was 18 (8.8-51.8) months. At the time of survey, the mean PFDI-20 score was 95.7 ± 53.7. The mean PISQ-12 score for all patients was 32.8 ± 7.2 and the median PGI-I score was 2.0 (interquartile range, 1.0-3.0). CONCLUSIONS: In this cohort of patients who underwent a combined robotic ventral rectopexy and sacrocolpopexy, patient-reported postoperative symptom bother was low, sexual function was high, and their overall condition was much improved.

Medium-Term Outcomes of Conservative and Surgical Treatments for Stress Urinary Incontinence: A Medicare Claims Analysis: Developed by the AUGS Payment Reform Committee.

OBJECTIVE: This study aimed to evaluate the 3- to 5-year retreatment outcomes for conservatively and surgically treated urinary incontinence (UI) in a population of women 66 years and older. METHODS: This retrospective cohort study used 5% Medicare data to evaluate UI retreatment outcomes of women undergoing physical therapy (PT), pessary treatment, or sling surgery. The data set used inpatient, outpatient, and carrier claims from 2008 to 2016 in women 66 years and older with fee-for-service coverage. Treatment failure was defined as receiving another UI treatment (pessary, PT, sling, Burch urethropexy, or urethral bulking) or repeat sling. A secondary analysis was performed where additional treatment courses of PT or pessary were also considered a treatment failure. Survival analysis was used to evaluate the time from treatment initiation to retreatment. RESULTS: Between 2008 and 2013, 13,417 women were included with an index UI treatment, and follow-up continued through 2016. In this cohort, 41.4% received pessary treatment, 31.8% received PT, and 26.8% underwent sling surgery. In the primary analysis, pessaries had the lowest treatment failure rate compared with PT (P<0.001) and sling surgery (P<0.001; survival probability, 0.94 [pessary], 0.90 [PT], 0.88 [sling]). In the analysis where retreatment with PT or a pessary was considered a failure, sling surgery had the lowest retreatment rate (survival probability, 0.58 [pessary], 0.81 [PT], 0.88 [sling]; P<0.001 for all comparisons). CONCLUSIONS: In this administrative database analysis, there was a small but statistically significant difference in treatment failure among women undergoing sling surgery, PT, or pessary treatment, but pessary use was commonly associated with the need for repeat pessary fittings.

Sexual Function in Women at 6 and 12 Months After Obstetric Anal Sphincter Injury: Is Pelvic Floor Physical Therapy Associated With Improved Outcomes?

IMPORTANCE: Women with obstetric anal sphincter injury (OASI) are at increased risk of postpartum sexual dysfunction. Risk persists beyond 3 years after perineal trauma in up to half of patients with OASI. OBJECTIVES: The aims of this study were to determine if postpartum pelvic floor physical therapy (PFPT) is associated with improved sexual function after vaginal delivery with OASI and to describe sexual function in patients with OASI at 6 and 12 months postpartum. STUDY DESIGN: This is a retrospective cohort study of patients with OASI. Women were grouped according to PFPT attendance. The Postpartum Pelvic Floor and Birth Questionnaire (PPFBQ), which compares current sexual function to baseline prepregnancy sexual function, and the Female Sexual Function Index (FSFI) were administered at 6 and 12 months, respectively, to evaluate postpartum sexual function. RESULTS: Two hundred women were included. Sixty-four (32%) women attended PFPT; 136 (68%) did not attend PFPT. Patients reported worse-than-baseline sexual function at 6 months postpartum in the PPFBQ sexual activity domain, but the PFPT group had lower median score than the non-PFPT group (2.3 [2.0, 2.8] vs 2.7 [2.1, 3.1], P = 0.034), with scores <3.0 indicating worse-than-baseline functioning. The FSFI composite scores were similar between groups and showed 80.7% of the patients with OASI meeting the criteria for female sexual dysfunction at 12 months postpartum. Attendance of PFPT was not significantly associated with composite FSFI scores and most domains of PPFBQ. CONCLUSIONS: Attendance of PFPT did not significantly impact overall sexual function in OASI patients at 6 and 12 months postpartum. Sexual function is complex and may be more effectively addressed in the postpartum period using a multidimensional approach.

Nonhome Discharge in Patients Undergoing Pelvic Reconstructive Surgery: A National Analysis.

IMPORTANCE: Discharge to home after surgery has been recognized as a determinant of long-term survival and is a common concern in the elderly population. OBJECTIVE: The aim of the study was to determine the incidence and risk factors for nonhome discharge in patients undergoing major surgery for pelvic organ prolapse. STUDY DESIGN: We performed a retrospective cohort study using the American College of Surgeons National Surgical Quality Improvement Program Database from 2010 to 2018. We included patients who underwent sacrocolpopexy, vaginal colpopexy, and colpocleisis. We compared perioperative characteristics in patients who were discharged home versus those who were discharged to a nonhome location. Stepwise backward multivariate logistic regression was then used to control for confounding variables and identify independent predictors of nonhome discharge. RESULTS: A total of 38,012 patients were included in this study, 209 of whom experienced nonhome discharge (0.5%). Independent predictors of nonhome discharge included preoperative weight loss (adjusted odds ratio [aOR], 5.9; 95% confidence interval [CI], 1.3-27.5), dependent health care status (aOR, 5.0; 95% CI, 2.6-9.5), abdominal hysterectomy (aOR, 2.3; 95% CI, 1.4-3.7), American Society of Anesthesiologists class 3 or greater (aOR, 2.0; 95% CI, 1.5-2.7), age (aOR, 1.1; 95% CI, 1.05-1.09), operative time (aOR, 1.005; 95% CI, 1.003-1.006), laparoscopic hysterectomy (aOR, 0.6; 95% CI, 0.4-1.0), and laparoscopic sacrocolpopexy (aOR, 0.5; 95% CI, 0.3-0.8). CONCLUSIONS: In patients undergoing surgery for pelvic organ prolapse, nonhome discharge is associated with various indicators of frailty, including age, health care dependence, and certain comorbidities. An open surgical approach increases the risk of nonhome discharge, while a laparoscopic approach is associated with lower risk.

The Impact of Pelvic Floor Physical Therapy on Bladder and Bowel Function After Obstetric Anal Sphincter Injury.

IMPORTANCE: Women with obstetric anal sphincter injury (OASI) are at increased risk of pelvic floor disorders. No standard of care exists for management of pelvic floor dysfunction after OASI. OBJECTIVES: The aims of this study were to evaluate the impact of pelvic floor physical therapy (PFPT) on bladder and bowel function after OASI and to describe adherence to PFPT. STUDY DESIGN: A retrospective cohort study of women with OASI presenting at a postpartum care clinic from 2017 to 2021 was conducted. Women were grouped according to PFPT attendance. Urinary Distress Inventory 6 (UDI-6) and Fecal Incontinence Severity Index (FISI) were administered at baseline and 6 months. RESULTS: A total of 430 women with OASI presented to a postpartum care clinic, of which 137 (31.9%) attended PFPT, and 293 (68.1%) did not attend. Baseline and 6-month questionnaires were completed by 169 women: 52 (30.8%) in the PFPT group and 117 (69.2%) in the non-PFPT group. Baseline UDI-6 and FISI scores were higher in the PFPT group. Improvement in UDI-6 was not different between groups (-5.8 ± 14.9 vs -3.7 ± 10.8, P = 0.36). The non-PFPT group had greater worsening of FISI compared with PFPT group (9.8 ± 15.2 vs 1.1 ± 11.5, P < 0.001). Sixty-six percent (n = 136) of women referred to PFFT attended at least 1 session, of which 32.4% (n = 44) completed all sessions. Completely adherent women were referred to PFPT earlier (18.5 vs 28.5 days postpartum, P = 0.027). CONCLUSIONS: Women in both the PFPT and non-PFPT groups reported improvement in bladder leakage 6 months after OASI. Women who did not attend PFPT had significant worsening of bowel leakage. Early referral to PFPT in women with pelvic floor dysfunction following OASI should be considered.

Postoperative void trial failure and same-day discharge following apical pelvic organ prolapse surgery: a retrospective matched case-control study.

INTRODUCTION AND HYPOTHESIS: Robust data comparing the timing of voiding trials following prolapse surgery are lacking. Filling in these knowledge gaps would be helpful in counseling patients preoperatively about the concerns regarding same-day discharge. We aimed to compare the rate of a failed void trial after apical pelvic organ prolapse (POP) repair between patients who were discharged on the day of surgery versus those discharged on postoperative day 1. METHODS: This was a retrospective matched case-control study of women who underwent either a laparoscopic/robotic or transvaginal apical POP surgery with or without concurrent hysterectomy. Patients who were discharged on postoperative day 0 (POD0) were identified as cases and matched to control patients discharged on postoperative day 1 (POD1). Patients were matched 1:1 based on age and surgical approach. RESULTS: A total of 59 patients in each group met the inclusion criteria. Of the entire cohort, 34 (28.8%) patients failed their void trial, with no statistically significant difference between those who were discharged on POD0 versus POD1 (33.9% vs 23.7%, p=0.47). Patients who were discharged on POD0 were more likely to be diagnosed with a urinary tract infection (22.0% vs 8.4%, p=0.041) during the postoperative period. CONCLUSIONS: In patients undergoing surgery for apical prolapse, there was no difference in the rate of void trial failure in those who had a catheter removal on the day of surgery compared with those who experienced removal the following day.

Racial and socioeconomic disparities in cost and postoperative complications following sacrocolpopexy in a US National Inpatient Database.

PURPOSE: We sought to determine the association between socioeconomic factors, procedural costs, and postoperative complications among patients who underwent sacrocolpopexy. METHODS: The 2016-2017 US National Inpatient Sample from the Healthcare Cost and Utilization Project was used to identify females > 18 years of age with an ICD10 diagnosis code of apical prolapse who received open or laparoscopic/robotic sacrocolpopexy. We analyzed relationships between socioeconomic factors, procedural costs, and postoperative complications in these patients. Multivariate logistic and linear regressions were used to identify variables associated with increased complications and costs, respectively. RESULTS: We identified 4439 women who underwent sacrocolpopexy, of which 10.7% had complications. 34.6% of whites, 29.1% of Blacks, 29% of Hispanics, and 34% of Others underwent a laparoscopic/robotic procedure. Hispanic patients had the highest median charge associated with surgical admission for sacrocolpopexy at $51,768, followed by Other ($44,522), White ($43,471), and Black ($40,634) patients. Procedure being within an urban teaching hospital (+ $2602), laparoscopic/robotic (+ $6790), or in the West (+ $9729) were associated with a significantly higher median cost of surgical management. CONCLUSIONS: In women undergoing sacrocolpopexy, the protective factors against postoperative complications included private insurance status, a laparoscopic approach, and concurrent hysterectomy. Procedures held within an urban teaching hospital, conducted laparoscopically/robotically or in the West are associated with significantly higher costs of surgical management. Hispanic patients observe significantly higher procedure charges and costs, possibly resulting from the large number of this ethnic group living in the Western United States.

Review of Vaginal Approaches to Apical Prolapse Repair.

PURPOSE OF REVIEW: To review recent literature and provide up-to-date knowledge on new and important findings in vaginal approaches to apical prolapse surgery. RECENT FINDINGS: Overall prolapse recurrence rates following transvaginal apical prolapse repair range from 13.7 to 70.3% in medium- to long-term follow-up, while reoperation rates for prolapse recurrence are lower, ranging from 1 to 35%. Subjective prolapse symptoms remain improved despite increasing anatomic failure rates over time. The majority of studies demonstrated improvement in prolapse-related symptoms and quality of life in over 80% of patients 2-3 years after transvaginal repair, with similar outcomes with and without uterine preservation. Contemporary studies continue to demonstrate the safety of transvaginal native tissue repair with most adverse events occurring within the first 2 years. Transvaginal apical prolapse repair is safe and effective. It is associated with long-term improvement in prolapse-related symptoms and quality of life despite increasing rates of prolapse recurrence over time. Subjective outcomes do not correlate with anatomic outcomes.

Postoperative complications and pelvic organ prolapse recurrence following combined pelvic organ prolapse and rectal prolapse surgery compared with pelvic organ prolapse only surgery.

BACKGROUND: There is a growing interest in combined pelvic organ prolapse and rectal prolapse surgery for concomitant pelvic floor prolapse despite a paucity of data regarding complications and clinical outcomes of combined repair. OBJECTIVE: The primary objective of this study was to compare the <30-day postoperative complication rate in women undergoing combined POP + RP surgery with that of women undergoing pelvic organ prolapse-only surgery. The secondary objectives were to describe the <30-day postoperative complications, compare the pelvic organ prolapse recurrence between the 2 groups, and determine the preoperative predictors of <30-day postoperative complications and predictors of pelvic organ prolapse recurrence. STUDY DESIGN: This was a multicenter, retrospective cohort study at 5 academic hospitals. Patients undergoing combined pelvic organ prolapse and rectal prolapse surgery were matched by age, pelvic organ prolapse stage by leading compartment, and pelvic organ prolapse procedure compared with those undergoing pelvic organ prolapse-only surgery from March 2003 to March 2020. The primary outcome measure was <30-day complications separated into Clavien-Dindo classes. The secondary outcome measures were (1) subsequent pelvic organ prolapse surgeries and (2) pelvic organ prolapse recurrence, defined as patients who complained of vaginal bulge symptoms postoperatively. RESULTS: Overall, 204 women underwent combined surgery for pelvic organ prolapse and rectal prolapse, and 204 women underwent surgery for pelvic organ prolapse only. The average age (59.3±1.0 vs 59.0±1.0) and mean parity (2.3±1.5 vs 2.6±1.8) were similar in each group. Of note, 109 (26.7%) patients had at least one <30-day postoperative complication. The proportion of patients who had a complication in the combined surgery group and pelvic organ prolapse-only surgery group was similar (27.5% vs 26.0%; P=.82). The Clavien-Dindo scores were similar between the groups (grade I, 10.3% vs 9.3%; grade II, 11.8% vs 12.3%; grade III, 3.9% vs 4.4%; grade IV, 1.0% vs 0%; grade V, 0.5% vs 0%). Patients undergoing combined surgery were less likely to develop postoperative urinary tract infections and urinary retention but were more likely to be treated for wound infections and pelvic abscesses than patients undergoing pelvic organ prolapse-only surgery. After adjusting for combined surgery vs pelvic organ prolapse-only surgery and parity, patients who had anti-incontinence procedures (adjusted odds ratio, 1.85; 95% confidence interval, 1.16-2.94; P=.02) and perineorrhaphies (adjusted odds ratio, 1.68; 95% confidence interval, 1.05-2.70; P=.02) were more likely to have <30-day postoperative complications. Of note, 12 patients in the combined surgery group and 15 patients in the pelvic organ prolapse-only surgery group had subsequent pelvic organ prolapse repairs (5.9% vs 7.4%; P=.26). In the combined surgery group, 10 patients (4.9%) underwent 1 repair, and 2 patients (1.0%) underwent 2 repairs. All patients who had recurrent pelvic organ prolapse surgery in the pelvic organ prolapse-only surgery group had 1 subsequent pelvic organ prolapse repair. Of note, 21 patients in the combined surgery group and 28 patients in the pelvic organ prolapse-only surgery group reported recurrent pelvic organ prolapse (10.3% vs 13.7%; P=.26). On multivariable analysis adjusted for number of previous pelvic organ prolapse repairs, combined surgery vs pelvic organ prolapse-only surgery, and perineorrhaphy at the time of surgery, patients were more likely to have a subsequent pelvic organ prolapse surgery if they had had ≥2 previous pelvic organ prolapse repairs (adjusted odds ratio, 6.06; 95% confidence interval, 2.10-17.5; P=.01). The average follow-up times were 307.2±31.5 days for the combined surgery cohort and 487.7±49.9 days for the pelvic organ prolapse-only surgery cohort. Survival curves indicated that the median time to recurrence was not statistically significant (log-rank, P=.265) between the combined surgery group (4.2±0.4 years) and the pelvic organ prolapse-only surgery group (5.6±0.4 years). CONCLUSION: In this retrospective cohort study, patients undergoing combined pelvic organ prolapse and rectal prolapse surgery had a similar risk of <30-day postoperative complications compared with patients undergoing pelvic organ prolapse-only surgery. Furthermore, patients who underwent combined surgery had a similar risk of recurrent pelvic organ prolapse and subsequent pelvic organ prolapse surgery compared with patients who underwent pelvic organ prolapse-only surgery.

Postoperative complications and recurrence rates after rectal prolapse surgery versus combined rectal prolapse and pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: Our primary objectives were to compare < 30-day postoperative complications and RP recurrence rates after RP-only surgery and combined surgery. Our secondary objectives were to determine preoperative predictors of < 30-day complications and RP recurrence. METHODS: A prospective IRB-approved cohort study was performed at a single tertiary care center from 2017 to 2020. Female patients with symptomatic RP underwent either RP-only surgery or combined surgery based on the discretion of the colorectal and FPMRS surgeons. Primary outcome measures were < 30-day complications separated into Clavien-Dindo (CD) classes and rectal prolapse on physical examination. RESULTS: Seventy women had RP-only surgery and 45 had combined surgery with a mean follow-up time of 208 days. Sixty-eight percent underwent abdominal RP repair, and 32% underwent perineal RP repair. Twenty percent had one or more complications, 14% in the RP-only group and 29% in the combined surgery group (p = 0.06). On multivariate analysis, combined surgery patients had a 30% increased risk of complications compared to RP-only surgery patients (RR = 1.3). Most of these complications were minor (14/17, 82.4%) and categorized as CD I or II, including urinary retention and UTI. Twelve percent of this cohort had RP recurrence, 11% in the RP-only group and 13% in the combined surgery group (p = 0.76). Preoperative risk factors for RP recurrence included a primary complaint of rectal bleeding (RR 5.5) and reporting stools consistent with Bristol Stool Scale of 1 (RR 2.1). CONCLUSION: Patients undergoing combined RP + POP surgery had a higher risk of complications and equivalent RP recurrence rates compared to patients undergoing RP-only surgery.

Does Rectocele on Defecography Equate to Rectocele on Physical Examination in Patients With Defecatory Symptoms?

OBJECTIVES: Our primary objective was to determine the association between rectocele size on defecography and physical examination in symptomatic patients. Our secondary objective was to describe the associations between both defecography and physical examination findings with defecatory symptoms and progression to surgical repair of rectocele. METHODS: We performed a retrospective review of all patients referred to a female pelvic medicine and reconstructive surgery clinic with a diagnosis of rectocele based on defecography and/or physical examination at a single institution from 2003 to 2017. Patients who did not have defecatory symptoms, did not undergo defecography imaging, or did not have a physical examination in a female pelvic medicine and reconstructive surgery clinic within 12 months of defecography imaging were excluded. RESULTS: Of 200 patients, 181 (90.5%) had a rectocele diagnosed on defecography and 170 (85%) had a rectocele diagnosed on physical examination. Pearson and Spearman tests of correlation both showed a positive relationship between the rectocele size on defecography and rectocele stage on physical examination; however, one was not reliable to predict the results of the other (Pearson correlation = 0.25; Spearman ρ = 0.29). The strongest predictor of surgery was rectocele stage on physical examination (P < 0.001). Size of rectocele on defecography was not a strong independent predictor for surgery (P = 0.01), although its significance improved with the addition of splinting (P = 0.004). CONCLUSIONS: Our results suggest that rectocele on defecography does not necessarily equate to rectocele on physical examination in patients with defecatory symptoms. Rectocele on physical examination was more predictive for surgery than rectocele on defecography.

Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports.

OBJECTIVES: Energy-based devices have gained momentum as minimally invasive procedures to treat both medical and cosmetic pelvic floor disorders including genitourinary syndrome of menopause, vaginal laxity, stress urinary incontinence, dyspareunia, and vulvar disorders such as lichen diseases and vestibulitis. However, the FDA recently issued a statement cautioning patients and providers that the safety and efficacy of energy-based devices for the treatment of vaginal symptoms has not been well established. Additionally, the FDA sent letters to the manufactures of energy-based devices with notifications that they could be violating the marketing standards of the FDA. The existing data on side effects is insufficient and limited to observational studies. We sought to characterize the safety events of vaginal energy-based devices by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database and specifically look at those events that occurred prior to the July 30, 2018 warning. METHODS: The MAUDE database was queried between September 30, 2013 and October 31, 2019 for all vaginal energy-based devices. The incidence of safety events was reported for these devices and the most common complaints were described and characterized. Event reporting was analyzed before and after July 30, 2018. RESULTS: Forty-two unique and relevant medical device reports (MDRs) were retrieved. The Mona Lisa Touch had the highest number of MDRs (40.5%) followed by ThermiVa (16.7%) and Viveve (14.2%). Each medical device report was associated with a single patient experience and within the 42 medical device reports, there were 85 complaints. A majority of the MDR complaints (52.9%) were also indications for energy-based devices procedures, which include vaginal pain, dyspareunia, lichen sclerosis, and urinary frequency. Two-thirds of the complaints (68.2%) were related to pain, but serious adverse events such as third-degree burns (3.5%) were rare. Most of the reportable events occurred before July 30, 2018 (83.3%), but most were reported after July 30, 2018 (78.6%). CONCLUSIONS: MAUDE-reported data suggests that the majority of patient complaints after vaginal energy-based device treatment include vaginal pain, bladder pain, and urinary symptoms. This study suggests that the majority of complaints are not severe, and some may be related to progression of the disease. The few severe adverse events reported in the MAUDE database may have contributed to the FDA warning regarding energy-based devices. Recall bias after the FDA warning, as well as the potential for litigation, may have prompted an increase in adverse event reporting after July 30, 2018.

Video Summary:http://links.lww.com/MENO/A650.

A cost-effectiveness analysis of vaginal carbon dioxide laser therapy compared with standard medical therapies for genitourinary syndrome of menopause-associated dyspareunia.

BACKGROUND: Topical vaginal estrogen therapy is considered the gold standard treatment for genitourinary syndrome of menopause-associated dyspareunia, but early investigations of energy-based devices show promise for patients with contraindications or those who are refractory to vaginal estrogen cream therapy. Although evaluating safety, efficacy, and long-term outcomes for novel technologies is critically important when new technologies become available to treat unmet healthcare needs, evaluation of the costs of these new technologies compared with existing therapies is also critically important but often understudied. OBJECTIVE: We sought to perform a cost-effectiveness analysis of 3 therapies for genitourinary syndrome of menopause, including vaginal estrogen therapy, oral ospemifene therapy, and vaginal CO2 laser therapy and determine if vaginal laser therapy is a cost-effective treatment strategy for dyspareunia associated with genitourinary syndrome of menopause. STUDY DESIGN: An institutional review board-exempt cost-effectiveness analysis was performed by constructing a decision tree using decision analysis software (TreeAge Pro; TreeAge Software, Inc, Williamstown, MA) using integrated empirical data from the published literature. Tornado plots and 1-way and 2-way sensitivity analyses were performed to assess how changes in the model's input parameters altered the overall outcome of the cost-effectiveness analysis model. RESULTS: All 3 treatment methods were found to be cost-effective below the willingness-to-pay threshold of $50,000.00 per quality-adjusted life year for moderate dyspareunia. The incremental cost-effectiveness ratio for vaginal CO2 laser therapy was $16,372.01 and the incremental cost-effectiveness ratio for ospemifene therapy was $5711.14. Although all 3 treatment strategies were on the efficient frontier, vaginal CO2 laser therapy was the optimal treatment strategy with the highest effectiveness. In a 1-way sensitivity analysis of treatment adherence, vaginal CO2 laser therapy was no longer cost-effective when the adherence fell below 38.8%. Vaginal estrogen cream and ospemifene therapies remained cost-effective treatment strategies at all ranges of adherence. When varying the adherence to 100% for all strategies, oral ospemifene therapy was "dominated" by both vaginal CO2 laser therapy and vaginal estrogen cream therapy. In a 2-way sensitivity analysis of vaginal CO2 laser therapy adherence and vaginal CO2 laser therapy cost, vaginal CO2 laser therapy still remained the optimal treatment strategy at 200% of its current cost ($5554.00) when the adherence was >55%. When the cost fell to 20% of its current cost ($555.40), it was the optimal treatment strategy at all adherence values above 29%. CONCLUSION: This study showed that vaginal fractional CO2 laser therapy is a cost-effective treatment strategy for dyspareunia associated with GSM, as are both vaginal estrogen and oral ospemifene therapies. In our model, vaginal CO2 laser therapy is the optimal cost-effective treatment strategy, and insurance coverage should be considered for this treatment option if it is proven to be safe and effective in FDA trials.

Surgical approach, complications, and reoperation rates of combined rectal and pelvic organ prolapse surgery.

OBJECTIVES: Our primary objective was to determine rectal prolapse (RP) and pelvic organ prolapse (POP) reoperation rates and postoperative < 30-day complications after combined RP and POP surgery at a single institution. METHODS: This was an IRB-approved retrospective cohort study of all female patients who received combined RP and POP surgery at a single tertiary care center from 2008 to 2019. Recurrence was defined as the need for subsequent repeat RP or POP surgery at any point after the index surgery. Surgical complications were separated into Clavien-Dindo classes. RESULTS: Sixty-three patients were identified, and 18.3% (12/63) had < 30-day complications (55% Clavien-Dindo grade 1; 27% Clavien-Dindo grade 2; 18% Clavien-Dindo grade 4). Of patients undergoing combined abdominal RP and POP repair, no postoperative < 30-day complications were noted in the MIS group compared to 37.5% of those patients in the laparotomy group (p < 0.01). Overall, in those patients who underwent combined RP and POP surgery, the need for subsequent RP surgery for recurrent RP was 14% and the need for subsequent POP surgery for recurrent POP was 4.8% (p = 0.25). CONCLUSION: In this cohort of women undergoing combined RP and POP surgery, a higher proportion required subsequent RP surgery compared to those requiring subsequent POP surgery, although this was not statistically significant. Almost one-fifth of patients undergoing combined RP and POP surgery experienced a < 30-day surgical complication, regardless of whether the approach was perineal or abdominal. For those patients undergoing abdominal repair, < 30-day complications were more likely in those patients who had a laparotomy compared to those who had a minimally invasive surgery.

Characterizing relaxin receptor expression and exploring relaxin's effect on tissue remodeling/fibrosis in the human bladder.

BACKGROUND: Relaxin is an endogenous protein that has been shown to have antifibrotic properties in various organ systems. There has been no characterization of relaxin's role in the human bladder. Our objective was to characterize relaxin receptor expression in the human bladder and assess relaxin's effect on tissue remodeling/fibrosis pathways in bladder smooth muscle cells. METHODS: Relaxin family peptide receptor 1 (RXFP1) and RXFP2 expression was assessed using quantitative reverse transcriptase-PCR (qRT-PCR) and immunohistochemistry (IHC) on primary bladder tissue. Primary human smooth muscle bladder cells were cultured and stimulated with various concentrations of relaxin. Western blot, qRTPCR, ELISA, and zymogram assays were used to analyze fibrosis/tissue remodeling pathway proteins. RESULTS: There was universal mRNA transcript detection and protein expression of relaxin receptors in primary bladder specimens. Immunohistochemistry demonstrated RXFP1 and RXFP2 localizing to both urothelial and smooth muscle cell layers of the bladder. 24 h of in vitro relaxin stimulation did not affect mRNA expression of selected proteins in human bladder smooth muscle cells. However, 48 h of in vitro relaxin stimulation resulted in upregulation of active (p = 0.004) and latent (p = 0.027) MMP-2 in cell lysate, and upregulation of active MMP-2 in supernatant (p = 0.04). There was a dose dependent relationship with increasing expression of MMP-2 with increasing relaxin concentration. Relaxin stimulation resulted in decreased levels of active and total TGF-ß1 in supernatant and extracellular matrix (p < 0.005 with 100 ng/mL relaxin stimulation). CONCLUSIONS: In the human bladder, relaxin receptors are expressed at the dome and trigone and localize to the urothelium and smooth muscle cell layers. Stimulation of human bladder SMCs with relaxin in vitro affects expression of MMP-2 and TGF-ß1.