Apical Suspension Repair for Vaginal Vault Prolapse: A Randomized Clinical Trial.

Importance: The optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined. Objective: To compare the efficacy and safety of 3 surgical approaches for vaginal vault prolapse after hysterectomy. Design, Setting, and Participants: This was a multisite, 3-arm, superiority and noninferiority randomized clinical trial. Outcomes were assessed biannually up to 60 months, until the last participant reached 36 months of follow-up. Settings included 9 clinical sites in the US National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. Between February 2016 and April 2019, women with symptomatic vaginal vault prolapse after hysterectomy who desired surgical correction were randomized. Data were analyzed from November 2022 to January 2023. Interventions: Mesh-augmented (either abdominally [sacrocolpopexy] or through a vaginal incision [transvaginal mesh]) vs transvaginal native tissue repair. Main Outcomes and Measures: The primary outcome was time until composite treatment failure (including retreatment for prolapse, prolapse beyond the hymen, or prolapse symptoms) evaluated with survival models. Secondary outcomes included patient-reported symptom-specific results, objective measures, and adverse events. Results: Of 376 randomized participants (mean [SD] age, 66.1 [8.7] years), 360 (96%) had surgery, and 296 (82%) completed follow-up. Adjusted 36-month failure incidence was 28% (95% CI, 20%-37%) for sacrocolpopexy, 29% (95% CI, 21%-38%) for transvaginal mesh, and 43% (95% CI, 35%-53%) for native tissue repair. Sacrocolpopexy was found to be superior to native tissue repair (adjusted hazard ratio [aHR], 0.57; 99% CI, 0.33-0.98; P = .01). Transvaginal mesh was not statistically superior to native tissue after adjustment for multiple comparisons (aHR, 0.60; 99% CI, 0.34-1.03; P = .02) but was noninferior to sacrocolpopexy (aHR, 1.05; 97% CI, 0-1.65; P = .01). All 3 surgeries resulted in sustained benefits in subjective outcomes. Mesh exposure rates were low (4 of 120 [3%] for sacrocolpopexy and 6 of 115 [5%] for transvaginal mesh) as were the rates of dyspareunia. Conclusions and Relevance: Among participants undergoing apical repair for vaginal vault prolapse, sacrocolpopexy and transvaginal mesh resulted in similar composite failure rates at study completion; both had lower failure rates than native tissue repair, although only sacrocolpopexy met a statistically significant difference. Low rates of mesh complications and adverse events corroborated the overall safety of each approach. Trial Registration: ClinicalTrials.gov Identifier: NCT02676973.

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.

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.

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.

Changes in sexual function over 12 months after native-tissue vaginal pelvic organ prolapse surgery with and without hysterectomy.

Background: There is a need to determine how preoperative sexual activity, uterine preservation, and hysterectomy affect sexual function after pelvic organ prolapse surgery. Aim: (1) To determine changes in sexual function in women, stratified by preoperative sexual activity status, after native-tissue pelvic organ prolapse surgery. (2) To examine the impact of hysterectomy and uterine preservation on sexual function. (3) To determine predictors for postoperative dyspareunia. Methods: This was a planned secondary analysis of a prospective cohort study. Sexual function was evaluated preoperatively and 6 and 12 months postoperatively. Sexual function was compared between those who had a hysterectomy and those who had uterine-preserving prolapse surgery. A logistic regression analysis was performed to assess predictors for dyspareunia. Outcomes: Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire. Results: At 12 months, 59 patients underwent surgery and were followed up (hysterectomy [n = 28, 47.5%] vs no hysterectomy [n = 31, 52.5%]; sexually active [n = 26, 44.1%] vs non-sexually active [n = 33, 55.9%]). Of those who did not undergo a hysterectomy, 17 (54.8%) had a uterine-preserving procedure. At 12 months, sexually active patients had significant improvement in sexual function (mean ± SD, 0.37 ± 0.43; P = .005), while non-sexually active patients reported significant improvement in satisfaction of sex life (P = .04) and not feeling sexually inferior (P = .003) or angry (P = .03) because of prolapse. No variables were associated with dyspareunia on bivariate analysis. Clinical Implications: It did not appear that either uterine preservation or hysterectomy had any impact on sexual function. There was a 10% increase in people who were sexually active after surgery. Strengths and Limitations: The major strength of our study is the use of a condition-specific validated questionnaire intended for sexually active and non-sexually active women. We interpreted our results utilizing a validated minimal clinically important difference score to provide interpretation of our results with statistical and clinical significance. The limitation of our study is that it was a secondary analysis that was not powered for these specific outcomes. Conclusion: At 12 months, for patients who were sexually active preoperatively, there was a clinically meaningful improvement in sexual function after native-tissue pelvic organ prolapse surgery. Non-sexually active women reported improvement in satisfaction of sex life. There was no difference in the sexual function of patients undergoing uterine preservation or posthysterectomy colpopexy when compared with those with concurrent hysterectomy, though this sample size was small.

Revision sacrocolpopexy: tips and tricks for optimal outcomes.

INTRODUCTION AND HYPOTHESIS: The aim of this video is to highlight important considerations and techniques for revision sacrocolpopexy in women with symptomatic recurrence of pelvic organ prolapse after sacrocolpopexy. METHODS: In this video, we show five patients who presented with recurrent symptomatic pelvic organ prolapse after prior sacrocolpopexy. We demonstrate techniques for robotic-assisted laparoscopic sacrocolpopexy revision including surgical dissection, revision of existing mesh, and/or addition of new mesh. CONCLUSIONS: Overall, revision sacrocolpopexy requires an individualized approach. These surgeries are often challenging because of adhesions and altered anatomy from the prior sacrocolpopexy. The reviewed considerations and techniques can be useful for ensuring a safe and effective outcome.

Determining the Ideal Intraoperative Resting Genital Hiatus Size-Balancing Surgical and Functional Outcomes.

IMPORTANCE: The intraoperative resting genital hiatus (GH) size can be surgically modified but its relationship to prolapse recurrence is unclear. OBJECTIVES: The objective of this study was to identify the optimal intraoperative resting GH size as it relates to prolapse recurrence and functional outcomes at 1 year. STUDY DESIGN: This prospective cohort study was conducted at 2 hospitals from 2019 to 2021. Intraoperative measurements of the resting GH, perineal body, and total vaginal length were collected. The composite primary outcome consisted of anatomic recurrence, subjective recurrence, and/or conservative or surgical retreatment at 1 year. Comparisons of anatomic, functional, and sexual outcomes were compared between patients stratified by the optimal intraoperative GH size identified by receiver operating characteristic curve analysis. RESULTS: Sixty-eight patients (median age of 63 years) underwent surgery, with 59 (86.8%) presenting for follow-up at 1 year. Based on the 13 patients (22%) with composite recurrence, receiver operating characteristic curve analysis demonstrated an intraoperative resting GH size of 3 cm, had 76.9% sensitivity (confidence interval [CI], 54-99.8%), and 34.8% specificity (CI, 21.0-48.5%) for composite recurrence at 1 year (area under curve = 0.61). Nineteen patients had an intraoperative GH less than 3 cm (32.2%) and 40 had a GH of 3 cm or greater (67.8%). The intraoperative resting GH size was significantly larger in patients with prolapse beyond the hymen at 1 year (4 cm [3.0, 4.0]) compared with those with prolapse at or proximal to the hymen (3.0 cm [2.5, 3.5], P = 0.009). CONCLUSIONS: Intraoperative GH size may not reliably predict composite prolapse recurrence at 1 year, although there was an association between intraoperative resting GH size with prolapse beyond the hymen.

Long-Term Outcomes After Vaginal and Laparoscopic Mesh Hysteropexy for Uterovaginal Prolapse: A Parallel Cohort Study (eVAULT).

IMPORTANCE: Data on long-term mesh hysteropexy outcomes are limited. This study provides 7-year data from the original VAULT (Vaginal and Laparoscopic Mesh Hysteropexy for Uterovaginal Prolapse Trial) study. OBJECTIVE: The aim of this study was to compare long-term outcomes and success for laparoscopic sacral hysteropexy (LSHP) and vaginal mesh hysteropexy (VMHP). STUDY DESIGN: This multicenter, prospective parallel cohort was an extension to the initial VAULT study. Subjects were contacted, and informed consent was obtained. We collected baseline demographics and the latest Pelvic Organ Prolapse-Quantification examination data from chart review and conducted telephone interviews to update demographic information and collect Pelvic Floor Distress Inventory Short-Form, Patient Global Impression of Improvement, prolapse reoperation/pessary use, and complications. Surgical success was defined as no bulge symptoms, satisfaction score of "very much better" or "much better," and no reoperation/pessary use. RESULTS: Five of 8 original sites enrolled 53 subjects (LSHP n = 34 and VMHP n = 19). The LSHP group was younger (67 vs 74, P < 0.01), but there were no differences in parity, body mass index, menopause, race, insurance, tobacco use, or Charlson Comorbidity Index. The median subjective follow-up was 7.3 ± 0.9 years. Composite success was 82% LSHP versus 74% VMHP. Pelvic Floor Distress Inventory Short-Form composite scores were similar at baseline and improved for both groups (P < 0.01) with lower bother observed in the LSHP group (20.8 vs 43.8, P = 0.01). There were no differences in complications. CONCLUSIONS: Over 7 years after surgery, LSHP and VMHP have high success, low retreatment, and low complication rates that did not differ between groups. Although there is a trend toward better anatomic support in the LSHP group, these findings were not significant and we are underpowered to detect a difference.

Long-term Urinary Outcomes After Transvaginal Uterovaginal Prolapse Repair With and Without Concomitant Midurethral Slings.

IMPORTANCE: Many health care providers place concomitant midurethral slings during pelvic organ prolapse repair, yet growing evidence supports staged midurethral sling placement. OBJECTIVES: The aim of this study was to compare urinary function after transvaginal uterovaginal prolapse repair with and without midurethral sling. STUDY DESIGN: Secondary analysis of the Study of Uterine Prolapse Procedures Randomized Trial (hysterectomy with uterosacral ligament suspension vs mesh hysteropexy). Our primary outcome was Urinary Distress Inventory score (UDI-6) through 5 years compared between women with and without a concomitant sling within prolapse repair arms. Sling effect was adjusted for select clinical variables and interaction terms (α = .05). RESULTS: The sling group included 90 women (43 hysteropexy, 47 hysterectomy), and the no-sling group included 93 women (48 hysteropexy, 45 hysterectomy). At baseline, the sling group reported more bothersome stress (66% vs 36%, P < 0.001) and urgency incontinence (69% vs 48%, P = 0.007). For hysteropexy, there were no significant long-term differences in UDI-6 scores or bothersome urine leakage between sling groups. For hysterectomy, women with sling had better UDI-6 scores across time points (adjusted mean difference, -5.1; 95% confidence interval [CI], -9.9 to -0.2); bothersome stress and urgency leakage were less common in the sling group (stress adjusted odds ratio, 0.1 [95% CI, 0.0-0.4]; urge adjusted odds ratio, 0.5 [95% CI, 0.2-1.0]). Treatment for stress incontinence over 5 years was similar in the sling (7.9%) versus no-sling (7.6%) groups. CONCLUSIONS: Five-year urinary outcomes of concomitant midurethral sling may vary by type of transvaginal prolapse surgery, with possible benefit of midurethral sling at the time of vaginal hysterectomy with apical suspension but not after mesh hysteropexy.

Intermediate term outcomes after transvaginal uterine-preserving surgery in women with uterovaginal prolapse.

INTRODUCTION AND HYPOTHESIS: There is growing interest in and performance of uterine-preserving prolapse repairs. We hypothesized that there would be no difference in pelvic organ prolapse (POP) recurrence 2 years following transvaginal uterosacral ligament hysteropexy (USLH) and sacrospinous ligament hysteropexy (SSLH). METHODS: This is a retrospective cohort study with a cross-sectional survey of women who underwent transvaginal uterine-preserving POP surgery from May 2016 to December 2017. Patients were included if they underwent either USLH or SSLH. POP recurrence was defined as a composite of subjective symptoms and/or retreatment. A cross-sectional survey was used to assess pelvic floor symptoms and patient satisfaction. RESULTS: A total of 47 women met the criteria. Mean age was 52.8 ± 12.5 years, and all had a preoperative POP-Q stage of 2 (55.3%) or 3 (44.7%). Thirty (63.8%) underwent SSLH and 17 (36.2%) underwent USLH. There were no differences in patient characteristics or perioperative data. There was no difference in composite recurrence (26.7% [8] vs 23.5% [4]) and retreatment (6.7% [2] vs 0%) retrospectively between SSLH and USLH groups at 22.6 months. Survey response rate was 80.9% (38) with a response time of 30.7 (28.0-36.6) months. The majority of patients (84.2%) reported POP symptom improvement, and both groups reported great satisfaction (89.5%). In respondents, 13.2% (5) reported subjective recurrence and 5.3% (2) underwent retreatment, with no differences between hysteropexy types. There were no differences in other pelvic floor symptoms. CONCLUSIONS: Although 1 in 4 women experienced subjective POP recurrence after transvaginal uterine-preserving prolapse repair and <5% underwent retreatment at 2 years, our results must be interpreted with caution given our small sample size. No differences in outcomes were identified between hysteropexy types; however, additional studies should be performed to confirm these findings. Both hysteropexy approaches were associated with great patient satisfaction.

Multicenter Randomized Controlled Trial of Pelvic Floor Muscle Training with a Motion-based Digital Therapeutic Device versus Pelvic Floor Muscle Training Alone for Treatment of Stress-predominant Urinary Incontinence.

OBJECTIVE: To determine whether use of an intravaginal motion-based digital therapeutic device for pelvic floor muscle training (PFMT) was superior to PFMT alone in women with stress-predominant urinary incontinence (SUI). METHODS: A multicenter, randomized-controlled trial was conducted where women with SUI or SUI-predominant mixed urinary incontinence were treated with either PFMT using the device (intervention group) or PFMT alone (control group). Primary outcomes, measured at 8 weeks, included change in Urinary Distress Inventory, short-version and improvement in the Patient Global Impression of Improvement, defined as "much better" or "very much better." Participants also completed Pelvic Organ Prolapse and Colorectal-anal Distress Inventories, Pelvic-Floor-Impact Questionnaire and a 3-day bladder diary. Primary analysis used a modified intention-to-treat approach. Statistical analysis used Student t test and χ2 test. The trial was prematurely halted due to device technical considerations. RESULTS: Seventy-seven women were randomized, and final analysis included 61 participants: 29 in intervention and 32 in control group. There was no statistical difference in Urinary Distress Inventory, short-version scores between the intervention (-13.7 ± 18.7) and the control group (-8.7 ± 21.8; P = 0.85), or in Patient Global Impression of Improvement (intervention 51.7% and control group 40.6%; P = 0.47). Pelvic Organ Prolapse and Colorectal-anal Distress Inventories and Pelvic-Floor-Impact Questionnaire scores improved significantly more in the intervention group than the control group (all P < 0.05). Median number of SUI episodes decreased from baseline to 8 weeks by -1.7 per-day [(-3)-0] in the intervention group and -0.7[(-1)-0] in the control group, (P = 0.047). CONCLUSIONS: In this prematurely terminated trial, there were no statistically significant differences in primary outcomes; however, PFMT with this digital therapeutic device resulted in significantly fewer SUI episodes and greater improvement in symptom-specific quality of life outcomes. A larger powered trial is underway.

Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial.

BACKGROUND: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market. OBJECTIVE: Our objective was to compare the efficacy and adverse events of these 2 procedures. STUDY DESIGN: At 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes. RESULTS: A total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% confidence interval, -33% to -3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively. CONCLUSION: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.

A prospective randomized trial comparing Restorelle® Y mesh and flat mesh for laparoscopic and robotic-assisted laparoscopic sacrocolpopexy: 24-month outcomes.

OBJECTIVE: To compare prolapse recurrence and the incidence of mesh exposure between Restorelle® Y mesh and dual flat mesh. METHODS: A randomized trial of women undergoing laparoscopic (LSC) or robotic (RSC) sacrocolpopexy for post-hysterectomy vaginal prolapse. Subjects were randomized to either Y mesh or dual flat mesh. Subjects underwent a pelvic examination with POP-Q and evaluation of any mesh exposure, and the PFDI-20 was administered at 6, 12 and 24 months postoperatively. Subjective recurrence was defined by symptomatic vaginal bulge. All subjects underwent pelvic examination with POP-Q at 6, 12 and 24 months. Objective recurrence was defined by descent of the apex > 1/3 into the vaginal canal, anterior or posterior vaginal descent beyond the hymen, or retreatment for prolapse. RESULTS: Sixty-two patients were enrolled, and 59 patients were implanted with mesh: 30 Y mesh (17 LSC, 13 RSC) and 29 flat mesh (18 LSC, 11 RSC). There were no differences in patient characteristics between the groups. At 24 months, data were available for 44 (74.5%) patients. There were no mesh exposures for all subjects. PFDI-20 scores improved significantly for all subjects with no differences in mean improvement by mesh configuration. There were no differences in subjective and objective recurrence rates between the groups. Four patients (9.1%) complained of subjective vaginal bulge symptoms while nine (20.5%) patients had an objective recurrence (77.8% [7] examination only and 22.2% [2] reoperation). There were no apical recurrences. Of those patients who had a recurrence on examination only (n = 7), 85.7% (6) were asymptomatic. CONCLUSIONS: At 24 months, there were no differences in subjective outcomes and prolapse recurrence in patients who underwent sacrocolpopexy with the Restorelle® Y mesh versus dual flat mesh. One in five patients experienced an objective recurrence; however, there were no apical recurrences and the majority were asymptomatic.

Same-Day Discharge After Minimally Invasive Sacrocolpopexy Is Feasible, Safe, and Associated With High Patient Satisfaction.

OBJECTIVES: This study aimed to compare the incidence of adverse events and postoperative health care resource utilization, as well as to determine satisfaction in patients after a same-day discharge (SDD) protocol compared with routine care (discharge ≥postoperative day 1). METHODS: This is a prospective cohort study of SDD after minimally invasive sacrocolpopexy. Eligibility criteria included age younger than 80 years, American Society of Anesthesiologists grade I/II, caretaker for ≥24 hours postoperatively, and surgical start before 1 pm. Perioperative data were obtained through the medical record and direct patient inquiry. A satisfaction survey was administered at the postoperative visit. A historical control group was used to compare outcomes. RESULTS: Forty-seven women met the eligibility criteria. Mean age was 62 (±9) years. Most were White (95.7%), were overweight (body mass index, 27.7 ± 5.5 kg/m2), and had stage 3 prolapse (63.8%). Same-day discharge was achieved for 37 patients (78.7%). Patient characteristics of the SDD cohort were similar to the routine-care cohort, with the exception of previous hysterectomy (57.5% vs 100.0%, P < 0.001) and the American Society of Anesthesiologists score (2 [1-2] vs 2 [1-3], P = 0.002). There were significantly fewer postoperative telephone calls in the SDD cohort but no other differences in health care resource utilization. Adverse events did not differ between groups. The SDD cohort reported high satisfaction and would recommend SDD to family or friends independent of whether or not SDD was achieved (91.9% vs 80.0%, P = 0.29). CONCLUSIONS: Nearly 80% of women undergoing minimally invasive sacrocolpopexy on an SDD protocol went home as planned. Compared with routine care, there was no increase in adverse events or postoperative health care resource utilization. Patient satisfaction in the SDD cohort was high. CLINICAL TRIAL REGISTRATION: Same-day discharge after minimally invasive sacrocolpopexy, https://clinicaltrials.gov/ct2/show/NCT03730103?term=same+day+discharge&cntry=US&state=US%3AOH&city=Cleveland&draw=2&rank=1; NCT03730103.

Predictors for Pelvic Organ Prolapse Recurrence After Sacrocolpopexy: A Matched Case-Control Study.

OBJECTIVE: This study aimed to identify risk factors for prolapse recurrence after sacrocolpopexy. METHODS: This was a retrospective chart review with cross-sectional follow-up survey of 709 patients who underwent sacrocolpopexy of any modality from 2004 to 2014. Cases were defined as those with a composite failure, defined as having subjective bulge symptoms, retreatment, or anatomic prolapse (≥stage 2 prolapse on the Pelvic Organ Prolapse Quantification system). Controls were patients without composite failure. The cases and controls were matched by surgeon and by date of surgery in a 1:4 ratio. RESULTS: We identified 153 cases and matched them to 487 controls. The overall incidence of prolapse recurrence was 21.6% (95% confidence interval [CI], 18.2%-24.1%). Of the recurrence cases, 34 (22.2%) underwent surgical retreatment; the most common surgical retreatment was a posterior colporrhaphy (n = 16 [47.1%]). On multivariable logistic regression, a preoperative genital hiatus size ≥4 cm (adjusted odds ratio [adjOR], 1.95; 95% CI, 1.18-3.25) and concurrent anterior colporrhaphy (adjOR, 2.11; 95% CI, 1.06-4.18) were associated with increased odds of having a composite failure. Patients who had a concurrent posterior colporrhaphy had lower odds of experiencing a failure (adjOR, 0.62; 95% CI, 0.42-0.94). CONCLUSIONS: In this large retrospective chart review of women who underwent sacrocolpopexy with a cross-sectional survey follow-up time frame of nearly 7 years, patients with a preoperative genital hiatus of 4 cm or greater and need for concurrent anterior colporrhaphy at the time of their index surgery had higher odds of prolapse recurrence. Conversely, women who underwent a concurrent posterior colporrhaphy had lower odds of a recurrence.

Does concurrent posterior repair for an asymptomatic rectocele reduce the risk of surgical failure in patients undergoing sacrocolpopexy?

PURPOSE: To determine if a concurrent posterior repair for an asymptomatic rectocele at the time of sacrocolpopexy reduces the incidence of surgical failure. METHODS: This is a retrospective chart review with a cross-sectional follow-up survey of all patients who underwent sacrocolpopexy from 2004 to 2014. Demographic and operative data were collected from the medical record. For the cross-sectional portion, patients were contacted to obtain information on symptoms and retreatment after surgery. In this study, we included patients with an asymptomatic rectocele on examination, defined as Ap or Bp ≥ -1 on POP-Q without defecatory dysfunction, which was defined as constipation based on the Rome III criteria, dyschezia, excessive straining and/or splinting to have a bowel movement. The primary outcome was a composite score of subjective bulge symptoms or retreatment for prolapse. RESULTS: Three hundred forty-four patients met the inclusion criteria: 185 (53.8%) had a sacrocolpopexy only (SCP) and 159 (46.2%) had a concurrent posterior repair (SCP + PR). The composite failure rate was 10.2% (95% CI = 7.4-13.8%), with a 13.5% (25) failure rate in the SCP group compared with 6.3% (10) in the SCP + PR group (p = 0.03). On multivariable logistic regression, the adjusted odds of failure was 2.79 in the SCP compared with the SCP + PR group (CI 1.25-6.23; P = 0.01). The rates of de novo defecatory dysfunction following surgery were low (SCP = 5.6% vs. SCP + PR = 7.5%, p = 0.55). CONCLUSIONS: For patients with asymptomatic rectoceles, a concurrent posterior repair at the time of sacrocolpopexy reduces the odds of composite patient-centered failure without an increased rate of dyspareunia or de novo defecatory dysfunction.

A randomized controlled noninferiority trial of reduced vs routine opioid prescription after prolapse repair.

BACKGROUND: Given the accelerating opioid crisis in the United States and evidence that patients use fewer opioid tablets than prescribed, surgeons may choose to decrease prescribed quantities. The effect this may have on patient satisfaction with pain control after hospital discharge is unknown. OBJECTIVE: The primary objective of this study was to compare patient satisfaction with postoperative pain control between patients receiving a routine or reduced quantity opioid prescription after prolapse repair. Secondary objectives included a comparison of opioid-related side-effects, the number of opioid tablets used, and the number of excess tablets prescribed between these groups. STUDY DESIGN: This was a single-center, unmasked, 2-arm, randomized controlled noninferiority trial of women who underwent a prolapse repair with a planned overnight hospitalization. Patients were assigned randomly to 1 of 2 study arms: routine (28 tablets of oxycodone 5 mg) or reduced (5 tablets) prescription of opioid tablets. Patients were eligible if they were at least 18 years of age and undergoing a prolapse repair with an anticipated overnight hospital stay. Exclusion criteria included a history of chronic pain, preoperative opioid use, intolerance to study medication, or a score of ≥30 on the Pain Catastrophizing Scale. In addition to their opioid prescription, all patients received multimodal pain medications at discharge. Patients were asked to complete 6 weeks of diaries to record pain and medication use. The primary outcome (patient satisfaction) was collected as part of a postoperative survey completed at patients' routine postoperative visit 6 weeks after surgery. The sample size for noninferiority was calculated at 59 patients per group for a total of 118 patients. RESULTS: One hundred eighteen patients were assigned randomly; the primary outcome was available for 116. The majority of patients were white, postmenopausal, and nonsmokers; the mean age was 62±10.4 years. The most common surgery was a hysterectomy with native tissue repair (n=71; 60%). One hundred ten patients (93%) were satisfied with postoperative pain control. Statistical analysis constructed for noninferiority showed that the difference between the groups was <15% (93% vs 93%; P=.005). Subjects in the reduced arm reported requiring an additional opioid prescription more frequently than in the routine arm (15% vs 2%; P=.01). Patients in the routine arm used more opioid tablets than the reduced arm (median, 3 [interquartile range, 0-14] vs 1 [interquartile range, 0-3]), but overall opioid utilization was low. As such, patients in the routine arm had significantly more unused opioid tablets (median, 26 [interquartile range, 15-28] vs 4 [interquartile range, 2-5]). CONCLUSION: Patient satisfaction with pain control was noninferior in patients who received a reduced quantity of opioid tablets after prolapse repair compared with those who received a routine prescription. A large quantity of excess opioid tablets was seen in both groups. Surgeons should consider prescribing 5-10 opioid tablets after prolapse repair surgery and consider applying these findings to postoperative prescribing after other gynecologic procedures.

A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: The VeLVET Trial.

OBJECTIVE: The aim of the study was to compare 6-month efficacy and safety for treatment of vaginal dryness/genitourinary syndrome of menopause in women undergoing fractionated CO2 vaginal laser therapy to women using estrogen vaginal cream. METHODS: This multicenter, randomized trial compared fractionated CO2 laser to estrogen cream at 6 institutions. We included menopausal women with significant vaginal atrophy symptoms and we excluded women with prolapse below stage 2, recent pelvic surgery, prior mesh surgery, active genital infection, history of estrogen sensitive malignancy, and other autoimmune conditions. The primary outcome was the visual analog scale vaginal dryness score. Secondary outcomes included evaluation of vaginal atrophy, quality of life symptoms, assessment of sexual function, and urinary symptoms. Adverse events (AEs) and patient global impression of improvement (PGI-I) and satisfaction were also assessed. RESULTS: Sixty-nine women were enrolled in this trial before enrollment was closed due to the Federal Drug Administration requiring the sponsor to obtain and maintain an Investigational Device Exemption. Of the 69 participants enrolled, 62 completed the 6-month protocol; 30 women were randomized to the laser and 32 to estrogen cream from June 2016 to September 2017. Demographics did not differ between groups except the laser group was less parous (0 [range 0-4] vs 2 [0-6], P = 0.04). On patient global impression, 85.8% of laser participants rated their improvement as "better or much better" and 78.5% reported being either "satisfied or very satisfied" compared to 70% and 73.3% in the estrogen group; this was not statistically different between groups. On linear regression, mean difference in female sexual function index scores was no longer statistically significant; and, vaginal maturation index scores remained higher in the estrogen group (adj P value 0.02); although, baseline and 6-month follow-up vaginal maturation index data were only available for 34 participants (16 laser, 18 estrogen). CONCLUSIONS: At 6 months, fractionated CO2 vaginal laser and vaginal estrogen treatment resulted in similar improvement in genitourinary syndrome of menopause symptoms as well as urinary and sexual function. Overall, 70% to 80% of participants were satisfied or very satisfied with either treatment and there were no serious adverse events. : Video Summary:http://links.lww.com/MENO/A470.