Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Controlled Trial.

OBJECTIVE: To compare postoperative urinary retention rates in the early postoperative period between home and office catheter removal. Secondary outcomes included pain, difficulty, satisfaction, likelihood to use again, and health care utilization. METHODS: We conducted a nonblinded, randomized controlled, noninferiority trial of women undergoing surgery for stress incontinence and prolapse from March 2021 to June 2022. Exclusion criteria were preoperative voiding dysfunction (need for self-catheterization or postvoid residual [PVR] greater than 150 mL), urethral bulking, and need for prolonged postoperative catheterization. Participants discharged with indwelling catheters because of an initial failed void trial were randomized 1:1 to home compared with office removal on postoperative day 3-4. For home removal, participants were instructed to remove the catheter at 7 am and to drink two glasses of water. If they had difficulty voiding 5 hours after catheter removal, they came to the office for a void trial. For office removal, participants returned for a backfill void trial with PVR assessment. Our primary outcome was rate of early postoperative urinary retention , defined as confirmed retention (PVR greater than half the voided volume) after catheter removal. Secondary outcomes were assessed at a 2-week call. Health care utilization (telephone calls and office visits) related to catheter issues was also assessed. At 80% power and α=0.05, we needed 100 participants (50/group) to detect a noninferiority margin of 11%. RESULTS: Among 117 participants, the home (n=59) and office (n=58) removal groups were similar in mean age (60 years vs 61 years), mean body mass index (29 vs 30), pelvic organ prolapse quantification system stage 3 or 4, and proportion who underwent hysterectomy or apical suspension. Sling procedures were more common in the office group (45.8% vs 77.6%). For our primary outcome, the rate of early postoperative retention was 11.9% in the home group and 22.4% in the office group ( P =.13). Our predetermined noninferiority margin was greater than the upper bound of our 95% CI; thus, we conclude noninferiority of home removal. For secondary outcomes, the home removal group was more likely to report "no pain" ( P =.02) and "very likely" to use this method again ( P =.004). There were no differences in difficulty or satisfaction between groups. Number of nursing calls was not different ( P =.66); however, number of office visits was higher in the office group (median 0 [interquartile range 0-1] vs 1 [1-1], P <.001). CONCLUSION: Postoperative urinary catheter removal by the patient at home was noninferior to office removal when early urinary retention rates were compared. Participants in the home removal group had fewer office visits and reported low pain, low difficulty, and high satisfaction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT04783012.

PROMIS pain intensity and interference after pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: Patient-Reported Outcome Measurement Information System (PROMIS) questionnaires provide valid comparisons across disciplines. Pain measures can be used to track functional outcomes. Limited PROMIS pain data exist in gynecological surgery. We sought to use pain intensity and pain interference short forms to assess pain and recovery after pelvic organ prolapse surgery. METHODS: The PROMIS pain intensity and pain interference questionnaires were given to patients undergoing uterosacral ligament suspension (USLS), sacrospinous ligament fixation (SSLF) or minimally invasive sacrocolpopexy (MISC) at baseline, 1 week, and 6 weeks postoperatively. Clinical minimally important change was defined as a difference of 2-6 T-score points. Mean pain intensity and pain interference T-scores were compared at baseline, 1 week and 6 weeks with ANOVA. Multiple linear regression assessed 1-week scores adjusted for apical suspension type, advanced prolapse, concurrent hysterectomy, concurrent anterior or posterior repair, and concurrent sling. RESULTS: At 1 week, all apical suspension groups showed minimally important change in pain intensity and pain interference T-scores. Between groups at 1 week, pain interference was higher in USLS (66.3±6.6) and MISC (65.5±5.9) than in SSLF (59.2±9.8), p=0.01. Multiple linear regression showed an association of hysterectomy with increases in pain intensity and pain interference. USLS had a higher proportion of concurrent hysterectomy (100%) than SSLF (0%) and MISC (30.8%), p<0.01. No difference was found based on apical suspension type alone. CONCLUSIONS: No differences were found in PROMIS pain intensity and pain at 1 week postoperatively after apical suspension procedures.

Preoperative Activity Level and Postoperative Pain After Pelvic Reconstructive Surgery.

IMPORTANCE: Higher preoperative activity level is associated with improved postoperative outcomes, but its impact on postoperative pain after urogynecologic surgery is unknown. OBJECTIVE: The aim of the study was to assess the relationship between preoperative activity level and postoperative pain. STUDY DESIGN: In this prospective cohort study, we evaluated women undergoing pelvic reconstructive surgery from April 2019 through September 2021. We used the Activity Assessment Survey (AAS) to create cohorts of high (AAS = 100) and low (AAS < 100) baseline activity (BA). Our primary outcome was postoperative pain scores. Our secondary outcome was postoperative opioid use. RESULTS: Of 132 patients, 90 (68%) were in the low BA group and 42 (32%) were in the high BA group. The groups were similar in age (mean 59 ± 12 years for high BA vs 60 ± 12 for low BA, P = 0.70), body mass index, and surgical procedures performed; however, the high BA group had lower preoperative pain scores (2 ± 6 vs 11 ± 9, P ≤ 0.01). For the primary outcome, the high BA group reported lower postoperative pain scores (16 ± 8 vs 20 ± 9, P = 0.02) and less opioid use (19 ± 32 vs 52 ± 70 morphine milliequivalents, P = 0.01) than the low BA group. However, when adjusting for age, baseline pain, hysterectomy, baseline opioid use, and Charlson Comorbidity Index, high BA did not remain associated with lower postoperative pain scores and less opioid use. CONCLUSION: A higher preoperative activity level among patients undergoing urogynecologic surgery was not associated with lower pain scores nor decreased opioid use.

Long-Term Pain After Minimally Invasive Total Hysterectomy and Sacrocolpopexy.

IMPORTANCE: There are limited long-term data on patient-reported pain after surgical treatment of uterovaginal prolapse. OBJECTIVE: This study aimed to evaluate pain in women undergoing minimally invasive total hysterectomy and sacrocolpopexy with a lightweight polypropylene Y-mesh (Upsylon) >2 years after surgery. STUDY DESIGN: This is a planned secondary analysis of a 5-site randomized trial comparing permanent versus absorbable suture for vaginal attachment of a lightweight polypropylene Y-mesh during total laparoscopic hysterectomy and sacrocolpopexy in women with stage ≥2 uterovaginal prolapse. Our primary outcome was patient-reported pain or dyspareunia at >2 years. RESULTS: Of the 185 participants eligible for enrollment in the e-PACT study, 106 enrolled; 98 participants (96%) completed either in-person examinations or study questionnaires regarding pain and are included in this analysis. At >2 years, 28% reported any pain: 14% reported dyspareunia on questionnaires, 5% reported pelvic pain on questionnaires, and 14% of those who had an in-person examination reported pain. Of participants who reported pain or dyspareunia at baseline before surgery, 59% reported resolution of their symptoms >2 years. On multiple logistic regression controlling for age and baseline pain or dyspareunia, baseline pain or dyspareunia was associated with a nearly 3-fold increased risk of reporting any pain >2 years (adjusted odds ratio, 2.7; 95% confidence interval, 1.1-6.9). No women had repeat surgical intervention for pain. CONCLUSIONS: Although 60% of women report pain resolution >2 years after surgery, de novo pain was present in 1 of 5 women. Baseline history of pain or dyspareunia is the only factor associated with an increased likelihood of experiencing pain >2 years after surgery.

Long-term mesh exposure after minimally invasive total hysterectomy and sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate total and incident mesh exposure rates at least 2 years after minimally invasive total hysterectomy and sacrocolpopexy. Secondary aims were to evaluate surgical success and late adverse events. METHODS: This extension study included women previously enrolled in the multicenter randomized trial of permanent vs delayed-absorbable suture with lightweight mesh for > stage II uterovaginal prolapse. Owing to COVID-19, women were given the option of an in-person (questionnaires and examination) or telephone visit (questionnaires only). The primary outcome was total and incident suture or mesh exposure, or symptoms suggestive of mesh exposure in women without an examination. Secondary outcomes were surgical success, which was defined as no subjective bulge, no prolapse beyond the hymen, and no pelvic organ prolapse retreatment, and adverse events. RESULTS: A total of 182 out of 200 previously randomized participants were eligible for inclusion, of whom 106 (58%) women (78 in-person and 28 via questionnaire only) agreed to the extension study. At a mean of 3.9 years post-surgery, the rate of mesh or suture exposure was 7.7% (14 out of 182) of whom only 2 were incident cases reported after 1-year follow-up. None reported vaginal bleeding or discharge, dyspareunia, or penile dyspareunia. Surgical success was 93 out of 106 (87.7%): 13 out of 94 (13.8%) failed by bulge symptoms, 2 out of 78 (2.6%) by prolapse beyond the hymen, 1 out of 85 (1.2%) by retreatment with pessary, and 0 by retreatment with surgery. There were no serious adverse events. CONCLUSIONS: The rate of incident mesh exposure between 1 and 3.9 years post-surgery was low, success rates remained high, and there were no delayed serious adverse events.

Examining Age and Postoperative Opioid Use in the Urogynecology Population: A Prospective Study.

IMPORTANCE: Surgeons must individualize postoperative pain management while also reducing the amount of unused prescribed opioids. OBJECTIVES: This study compared postoperative opioid use in younger versus older women following urogynecologic surgery. We also assessed the likelihood of women returning unused opioids for safe disposal. STUDY DESIGN: This was a prospective study of women undergoing pelvic reconstructive surgery divided into 2 cohorts: younger (<65 years) and older (≥65 years). Our primary outcome was total opioid use, measured in morphine milligram equivalents (MME). We also assessed the average pain score during the first week after surgery measured by a numerical pain scale (range, 0-10). Our secondary outcome was the rate of return of unused prescribed opioids at the 6-week postoperative visit utilizing a disposable drug deactivation system. RESULTS: From April 2019 to September 2021, 152 participants were enrolled: 92 (61%) in the younger cohort (mean age, 51 ± 8 years) and 60 (39%) in the older cohort (mean age, 72 ± 6 years). For our primary outcome, younger women used significantly more opioids during the first postoperative week compared with older women (49 ± 71 vs 28 ± 40 MME, respectively, P = 0.04), despite no difference in average pain scores (4 ± 2 younger vs 3 ± 2 older, P = 0.05). For our secondary outcome, 23% of participants returned their opioids for disposal with the drug deactivation system. CONCLUSIONS: Younger women had higher postoperative opioid use despite similar pain scores after urogynecologic surgery. Among those prescribed opioids, a quarter of participants returned their opioids for disposal at their postoperative visit.

Thirty-six-month Prospective Study of Transvaginal Bovine Graft vs Native Tissue Repair for the Treatment of Pelvic Organ Prolapse.

OBJECTIVE(S): To compare the safety and effectiveness of dermal bovine transvaginal graft, Xenform, to native tissue in the surgical treatment of anterior and/or apical pelvic organ prolapse. This study was designed in conjunction with Food and Drug Administration requirements. METHODS: This was a prospective, non-randomized, parallel cohort, multi-center trial. The primary objective was to demonstrate noninferiority between transvaginal graft and native tissue repair at 36 months compared to baseline. Treatment success was based on a composite of objective and subjective measures. The co-primary outcome was the rate of serious device- or procedure-related adverse events. A total of 228 patients at 25 sites were included in the study arm and 485 patients underwent native tissue repair. Propensity score stratification was applied to achieve balance between treatment groups. Study outcomes were compared in per protocol and intent-to-treat analysis. RESULTS: The primary outcome, treatment success at 36 months, was 83.6% (191/228) for transvaginal graft and 80.5% (390/485) native tissue repair (0.2%, 90% confidence interval [-5.6% to 5.9%]), demonstrating noninferiority at a preset margin of -12%. The overall rate of severe adverse events was 5.3% (12/228) in transvaginal graft vs 2.7% (13/485) in native tissue repair groups. The study group demonstrated noninferiority in serious adverse events at the preset margin of 11.6% (2.0%, 90% confidence interval [-0.8% to 4.7%]). There were no reports of graft erosion, and graft exposure rates were low (0.9% [2/228]). CONCLUSIONS: Transvaginal repair of anterior and/or apical prolapse with a biological graft is noninferior to traditional native tissue repair in effectiveness and safety at 36 months.

Are Formal Voiding Trials Necessary After Posterior Compartment Reconstructive Surgery?

IMPORTANCE: Posterior compartment surgery is considered a risk factor for postoperative urinary retention because of the impact of postoperative pain on the pelvic floor; however, few studies have examined the association between posterior compartment reconstructive surgery and urinary retention. OBJECTIVE: The aim of the study was to compare rates of urinary retention in patients undergoing vaginal reconstructive surgery, without hysterectomy, in the posterior compartment only versus any apical and/or anterior compartment (with or without posterior compartment). STUDY DESIGN: In this retrospective cohort study, we evaluated patients who underwent surgery, without hysterectomy, in the posterior compartment only versus any apical and/or anterior compartment (with or without posterior compartment) from January 2015 to November 2020. Our primary outcome was rate of postoperative urinary retention, defined as a failed voiding trial before discharge. Secondary outcome was days of catheterization. Multivariable logistic regression was performed to assess variables associated with a failed voiding trial. RESULTS: Of 362 patients, 141 (39.0%) underwent surgery in the posterior compartment only and 221 (61.0%) underwent vaginal apical and/or anterior compartment surgical procedures. Rate of retention was significantly lower in the posterior compartment only group (9.9% vs 41.6%, P < 0.001). The median numbers of days of catheterization were significantly fewer in the posterior compartment only group (0 [0,0] vs 0 [0,3], P < 0.001). In multivariable logistic regression, posterior compartment only surgery was associated with passing the voiding trial (odds ratio, 6.0; 95% confidence interval, 2.97-12.03). CONCLUSIONS: Rates of postoperative urinary retention after surgery in the posterior compartment are low, and these patients may not require formal voiding trials after surgery.

A Randomized Clinical Trial Comparing the Efficacy and Safety of 2% Versus 4% Chlorohexidine Gluconate for Surgical Preparation of the Vagina.

IMPORTANCE: There have been no studies comparing 2% and 4% chlorhexidine gluconate (CHX) for vaginal surgical site preparation despite both commonly being used. OBJECTIVES: The primary objective was to assess the noninferiority of 2% CHX versus 4% CHX to reduce bacterial contamination rates at 60 minutes after surgical preparation of the vagina. Secondary objectives were to assess differences in colony-forming units and the sensation of postoperative vaginal burning and pain. STUDY DESIGN: This is a single-blinded randomized controlled trial of women who underwent vaginal prolapse surgery. Study participants were randomized into 2 groups: 2% CHX versus 4% CHX. Two vaginal bacterial cultures were collected: (1) preoperatively before vaginal preparation and (2) intraoperatively at 60 minutes. A questionnaire on vaginal pain and burning was administered preoperatively and postoperatively. For our sample size, assuming that 2% CHX would have double the contamination rate of 4% CHX, 26 participants were needed per group to demonstrate noninferiority. RESULTS: Sixty-one women participated in the study. There were no differences in baseline demographics, length of surgery, or surgical procedures. For our primary outcome, the postpreparation contamination rates were 7% for 2% CHX versus 10% for 4% CHX, with a difference of 3% ( P = 0.52). This difference did meet the criteria for noninferiority. Secondary outcomes were not different between groups. CONCLUSIONS: Two percent CHX is noninferior to 4% CHX in reducing vaginal bacterial contamination at 60 minutes after vaginal surgical site preparation, with low rates of postpreparation contamination and vaginal discomfort.

Mortality and Reoperation Following Midurethral Sling Versus Urethral Bulking in Older Women.

OBJECTIVE: To examine differences in mortality, retreatment rates, and comorbidities that may be risk factors for retreatment among Medicare beneficiaries (age 65+) undergoing midurethral sling vs urethral bulking. MATERIALS AND METHODS: This was a retrospective cohort study using the 5% limited data set from the Center for Medicare and Medicaid Services between 2010 and 2018. Beneficiaries age 65 or older who underwent sling or bulking without concomitant surgery from 2011 to 2014 were included and followed until reoperation or retreatment, loss of Medicare, death, or December 31, 2018. Repeat procedures for ongoing stress incontinence or complication were included. Associations between index treatment and need for a secondary procedure were evaluated using Cox proportional hazards models. RESULTS: Median follow-up time was 5.7 years for 1,700 patients undergoing sling and 5.2 years for 875 patients undergoing bulking. Within 5 years, 10.2% of sling patients and 23.2% of bulking patients had died. When controlling for age, race, and comorbidities, bulking patients were 1.73 times more likely than sling patients to die during the study period. Bulking patients were significantly more likely to have 12 of the 16 of the medical comorbidities evaluated. By 5 years, 6.7% of sling patients had been retreated for stress urinary incontinence (SUI) compared with 24.6% of bulking patients. Apart from hypertension, none of the comorbidities evaluated was associated with a difference in the risk of a subsequent surgical procedure. Members of racial and ethnic minority groups were less likely to be retreated. CONCLUSION: Older adults undergoing bulking are notably sicker and have shorter life expectancy as compared with those undergoing sling, suggesting these factors heavily guide patient selection. Comorbidities do not predispose patients to reoperation or retreatment.

Randomized Clinical Trial of Gabapentin Versus Placebo for Pain After Sacrospinous Ligament Fixation.

OBJECTIVES: Given the risk of postoperative pain and specifically neuropathic gluteal pain after a sacrospinous ligament suspension, we conducted a randomized trial to compare a 2-week course of gabapentin versus placebo on postoperative pain after a sacrospinous ligament fixation. METHODS: This double-blinded, randomized, placebo-controlled trial compared 2 weeks of gabapentin (300 mg nightly for 3 days and then 300 mg twice a day for 11 days) versus identical-appearing placebo after a sacrospinous ligament fixation procedure. The primary outcome was participant-reported average pain during normal activity in the past 24 hours (score 0-10 on the validated Surgical Pain Scale) assessed on postoperative day (POD) 7. We also assessed average pain at rest and gluteal (buttocks) pain (score 0-10). We needed 17 participants per group to detect a 2.5-point difference in Surgical Pain Scale score with an SD of 2.6 (α = 0.05; power, 80%). RESULTS: The final intention-to-treat analysis compared 19 (49%) in the gabapentin group versus 20 (51%) in the placebo group. Between the gabapentin and placebo groups, average pain (2.0 ± 2.0 vs 3.4 ± 2.8, P = 0.09, respectively) and gluteal pain (2.1 ± 2.0 vs 3.4 ± 2.4, P = 0.09) during normal activity on POD 7 were not significantly different. However, average pain at rest on POD 7 was lower with gabapentin (1.6 ± 1.5 vs 3.2 ± 2.6, P = 0.04). CONCLUSIONS: Although a 2-week course of gabapentin did not significantly decrease overall pain with normal activity after a sacrospinous ligament fixation procedure, pain at rest was lower with gabapentin compared with placebo.

Long-Term Outcomes After Midurethral Mesh Sling Surgery for Stress Urinary Incontinence.

OBJECTIVES: Although midurethral mesh slings are the criterion standard surgical treatment for stress urinary incontinence (SUI), limited data exist regarding long-term outcomes. Thus, our objectives were to evaluate the long-term risk of sling revision and the risk of repeat SUI surgery up to 15 years after the initial sling procedure and to identify predictors of these outcomes. METHODS: Using a population-based cohort of commercially insured individuals in the United States, we identified women aged 18 years or older who underwent a sling procedure between 2001 and 2018. For sling revision, we evaluated indications (mesh exposure or urinary retention). We estimated the cumulative risks of sling revision and repeat SUI surgery annually using Kaplan-Meier survival curves and evaluated predictors using Cox proportional hazards models. RESULTS: We identified 334,601 mesh sling surgical procedures. For sling revision, the 10-year and 15-year risks were 6.9% (95% confidence interval [CI], 6.7-7.0) and 7.9% (95% CI, 7.5-8.3), with 48.7% of sling revisions associated with mesh exposure. The 10-year and 15-year risks of repeat SUI surgery were 14.5% (95% CI, 14.2-14.8) and 17.9% (95% CI, 17.3-18.6). Women aged 18-29 years had an elevated risk for both sling revision (hazard ratio, 1.20; 95% CI, 1.15-1.25) and repeat SUI surgery (hazard ratio, 1.30; 95% CI, 1.25-1.37) compared with women 70 years and older. CONCLUSIONS: In our study population, the 15-year risk of sling revision was 7.9%, with nearly half of revisions due to mesh exposure. These findings provide critical long-term data to support informed decisions for women and health care providers considering midurethral mesh slings.

A randomized trial comparing continence pessary to continence device (Poise Impressa®) for stress incontinence.

INTRODUCTION AND HYPOTHESIS: To conduct a multi-centered randomized trial evaluating stress urinary incontinence (SUI) treatment based on the Patient Global Impression of Improvement score after 4 weeks using a continence pessary (CP) or a disposable intravaginal continence device (DICD). The null hypothesis is no difference in treatment success between cohorts. METHODS: This parallel group, active treatment comparative effectiveness trial randomized women with SUI to either CP or DICD for 4 weeks in a 1:1 allocation ratio. Exclusion criteria included pregnancy, UTI, postmenopausal bleeding, neurogenic bladder, urinary retention, prolapse, contraindication to or prior treatment with CP/DICD, and prior SUI surgery. Assuming an 80% power, an alpha of 5% and 20% dropout, we needed 138 participants to detect 50% success with CP versus 25% with DICD. Due to slow enrollment, the study was stopped after 16 months with 50 participants enrolled. RESULTS: Of the 50 women enrolled, 25 (50%) were randomized to CP and 25 (50%) to DICD. Thirty-five of 50 (70%) completed a fitting, and 22/50 (44%) completed 4-week and 17/50 (34%) completed 6-month follow-up. Baseline characteristics were similar, and there was high treatment success in each cohort [80% (8/10) CP vs. 75% (9/12) DICD; p = 1.0]. DICD patients showed improvement on all questionnaires but had higher use of other therapies over 6 months. CP patients showed improvements except for lower sexual function scores at 4 weeks. No serious adverse events occurred. CONCLUSIONS: Most women fitted with a CP/DICD experienced treatment success after 4 weeks without serious adverse events.

Sexual Function after Minimally Invasive Total Hysterectomy and Sacrocolpopexy.

STUDY OBJECTIVE: To evaluate sexual function in women undergoing minimally invasive total hysterectomy and sacrocolpopexy (TLH + SCP) with a lightweight polypropylene Y-mesh 1 year after surgery. DESIGN: This was a planned secondary analysis of a 5-site randomized trial comparing permanent (2-0 Gore-Tex; W. L. Gore & Associates, Inc., Newark, DE) vs absorbable suture (2-0 polydioxanone suture) for vaginal attachment of a Y-mesh (Upsylon; Boston Scientific Corporation, Natick, MA) graft during TLH + SCP. SETTING: Multicenter trial at 5 study sites (4 academic and 1 community). The study sites were: (1) University of North Carolina at Chapel Hill, Chapel Hill, NC; (2) Wake Forest Baptist Hospital, Winston-Salem, NC; (3) Northwestern University, Evanston, IL; (4) Georgia Regents University, Augusta, GA; and (5) Atlantic Health Medical Group, Morristown, NJ. PATIENTS: Women previously enrolled in an original study undergoing TLH + SCP. INTERVENTIONS: Quality-of-life questionnaires and physical examination. MEASUREMENTS AND MAIN RESULTS: The primary objective was to assess changes in sexual function at 1 year after surgery as measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Urogynecological Association-Revised. The secondary objective was to assess the factors associated with postoperative sexual activity and dyspareunia. Of the 200 participants enrolled, 182 (92.8%) completed follow-up: n = 95/99 Gore-Tex and n = 87/101 polydioxanone suture. The mean age was 60 ± 10 years; body mass index was 27 ± 5 kg/m2; 78% were menopausal and 56% sexually active before surgery. At 1 year after surgery, 63% were sexually active: 93% of the sexually active women preoperatively remained so at 1 year, and 24% reported new sexual activity at 1 year (p <.001). Sexual function at 1 year showed marked improvement in activity, quality, and arousal/orgasm compared with baseline Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire scores. Dyspareunia rates decreased from 22% preoperatively to 16.5% at 1 year (p = .65). Women who were sexually active at 1 year were younger (56.8 ± 9.6 years vs 65.4 ± 9.2 years, p <.001), more likely to be premenopausal (31.6% vs 7.4%, p = .001), and less likely to undergo bilateral salpingo-oophorectomy (53.3% vs 78.9%, p <.001). CONCLUSION: Women undergoing TLH + SCP with a lightweight mesh graft report increased rates of sexual activity, improved sexual quality and arousal/orgasm, and lower rates of dyspareunia at 1 year after surgery.

Is a Postvoid Residual Necessary? A Randomized Trial of Two Postoperative Voiding Protocols.

OBJECTIVES: This study aimed to compare a backfill-assisted voiding trial (VT) with and without a postvoid residual (PVR) after pelvic reconstructive surgery. METHODS: This was a nonblinded randomized controlled trial of women undergoing pelvic organ prolapse and/or stress incontinence surgery. Participants were randomized immediately after surgery to either a PVR VT or a PVR-free VT. Our primary outcome was the rate of VT failure at discharge. Secondary outcomes included days of catheterization, urinary tract infection (UTI), and prolonged voiding dysfunction. With a power of 80% and an α of 0.05, we needed 126 participants to detect a 25% difference in VT failure (60% in PVR VT vs 35% in PVR-free VT). RESULTS: Participants were enrolled from March 2017 to October 2017. Of the 150 participants, mean age was 59 years, and 33% underwent vaginal hysterectomy, 48% underwent anterior repair, and 75% underwent midurethral sling. Seventy-five (50%) were randomized to PVR VT and 75 (50%) to PVR-free VT, with no differences in baseline demographic or intraoperative characteristics between the 2 groups. Our primary outcome, VT failure, was not significantly different (53% PVR VT vs 53% PVR-free VT, P = 1.0). There were no significant differences in days of postoperative catheterization (1 [0, 4] in PVR VT vs 1 [0, 4] in PVR-free VT, P = 0.90), UTI (20% PVR VT vs 20% PVR-free VT, P = 1.0), or postoperative voiding dysfunction (4% PVR VT vs 5% PVR-free VT, P = 1.0). CONCLUSIONS: When performing a backfill-assisted VT, checking a PVR does not affect VT failure, postoperative duration of catheterization, UTI, or voiding dysfunction.

Pain after permanent versus delayed absorbable monofilament suture for vaginal graft attachment during minimally invasive total hysterectomy and sacrocolpopexy.

OBJECTIVES: The objective was to evaluate pain and dyspareunia in women undergoing minimally invasive total hysterectomy and sacrocolpopexy (TLH + SCP) with a light-weight polypropylene mesh 1 year after surgery. METHODS: This is a planned secondary analysis of a randomized trial comparing permanent (Gore-Tex) versus absorbable suture (PDS) for vaginal attachment of a y-mesh (Upsylon™) during TLH + SCP in women with stage ≥II prolapse. Patient data were collected at baseline and 1 year after surgery. Our primary outcome was patient-reported pain or dyspareunia at 1 year. RESULTS: Two hundred subjects (Gore-Tex n = 99, PDS n = 101) were randomized and underwent surgery. Overall, the mean age ± SD was 60 ± 10 years, and BMI was 27 ± 5 kg/m2. The majority were white (89%), menopausal (77%), and had stage III/IV (63%) prolapse. 93% completed a 1-year follow-up and are included in this analysis (Gor-Tex n = 95, PDS n = 90). The overall rate of participants who reported pain at 1 year was 20%. Of those who did not report any pain at baseline, 23% reported de novo dyspareunia, 4% reported de novo pain, and 3% reported both at 1 year. Of participants who reported pain or dyspareunia at baseline prior to surgery, 66% reported resolution of their symptoms at 1 year. There were no differences in most characteristics, including mesh/suture exposure (7% vs 5%, p = 0.56) between patients who did and did not report any pain at 1 year. On multiple logistic regression controlling for age, baseline dyspareunia, and baseline pain, baseline dyspareunia was associated with a nearly 4-fold increased odds of reporting any pain at 1 year (OR 3.8, 95%CI 1.7-8.9). CONCLUSIONS: The majority of women report resolution of pain 1 year following TLH + SCP with a low rate of de novo pain.

Perioperative opioid prescriptions associated with stress incontinence and pelvic organ prolapse surgery.

BACKGROUND: There is an opioid epidemic in the United States with a contributing factor of opioids being prescribed for postoperative pain after surgery. OBJECTIVE: Among women who underwent stress urinary incontinence and pelvic organ prolapse surgeries, our primary objective was to determine the proportion of women who filled perioperative opioid prescriptions and to compare factors associated with these opioid prescriptions. We also sought to assess the risk of prolonged opioid use through 1 year after stress urinary incontinence and pelvic organ prolapse surgeries. STUDY DESIGN: Using a population-based cohort of commercially insured individuals in the 2005-2015 IBM MarketScan databases, we identified opioid-naive women ≥18 years who underwent stress urinary incontinence and/or pelvic organ prolapse procedures based on Current Procedural Terminology codes. We defined the perioperative period as the window beginning 30 days before surgery extending until 7 days after surgery. Any filled opioid prescription in this window was considered a perioperative prescription. For our primary outcome, we reported the proportion of opioid-naive women who filled a perioperative opioid prescription and reported the median quantity dispensed in the perioperative period. We also assessed demographic and perioperative factors associated with perioperative opioid prescription fills. Previous studies have defined prolonged use as the proportion of women who fill an opioid prescription between 90 and 180 days after surgery. We report this estimate as well as continuous opioid use, defined as the proportion of women with ongoing monthly opioid prescriptions filled through 1 year after stress urinary incontinence and/or pelvic organ prolapse surgery. RESULTS: Among the 217,460 opioid-naive women who underwent urogynecologic surgery, 61,025 (28.1%) had pelvic organ prolapse and stress urinary incontinence surgeries, 85,575 (39.4%) had stress urinary incontinence surgery without pelvic organ prolapse surgery, and 70,860 (32.6%) had pelvic organ prolapse surgery without stress urinary incontinence surgery. Overall, 167,354 (77.0%) filled a perioperative opioid prescription, and the median quantity was 30 pills (interquartile range, 20-30). In a multivariate regression model, younger age, pelvic organ prolapse surgery with or without stress urinary incontinence surgery, abdominal route, hysterectomy, and mesh use remained significantly associated with opioid prescriptions filled. Among those with a filled perioperative opioid prescription, the risk of prolonged use defined as an opioid prescription filled between 90 and 180 days was 7.5% (95% confidence interval, 7.3-7.6). However, the risk of prolonged use defined as continuous use with at least 1 monthly opioid prescription filled after surgery was significantly lower: 1.2% (1.13-1.24), 0.32% (0.29-0.35), 0.06% (0.05-0.08), and 0.04% (0.02-0.05) at 60, 90, 180, and 360 days after surgery, respectively. CONCLUSION: Among privately insured, opioid-naive women undergoing stress urinary incontinence and/or pelvic organ prolapse surgery, 77% of women filled an opioid prescription with a median of 30 opioid pills prescribed. For prolonged use, 7.5% (95% confidence interval, 7.3-7.6) filled an opioid prescription within 90 to 180 days after surgery, but the rates of continuously filled opioid prescriptions were significantly lower at 0.06% (95% confidence interval, 0.05-0.08) at 180 days and 0.04% (95% confidence interval, 0.02-0.05) at 1 year after surgery.

Permanent Compared With Absorbable Suture for Vaginal Mesh Fixation During Total Hysterectomy and Sacrocolpopexy: A Randomized Controlled Trial.

OBJECTIVE: To compare mesh and permanent suture exposure rates in the first year after minimally invasive total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh using permanent or delayed absorbable sutures. METHODS: Across five centers in the United States, women were randomized to permanent or delayed absorbable suture for vaginal attachment of a Y-mesh during hysterectomy and sacrocolpopexy for stage II prolapse and worse. The primary outcome was mesh or permanent suture exposure in the first year after surgery. The secondary outcome was to compare a composite measure for success defined as leading edge of prolapse not beyond the hymen and apex not descended more than one third vaginal length, and no subjective bulge and no prolapse retreatment. Patients completed a pelvic examination including the pelvic organ prolapse quantification system and questionnaires at baseline, 6 weeks and 1 year postsurgery. A sample size of 80 per group was planned to compare the rate of mesh or permanent suture exposure in the permanent compared with delayed absorbable groups. RESULTS: From April 2015 to May 2019, 204 patients (n=102 permanent; n=102 delayed absorbable) were randomized. One hundred ninety-eight women had follow-up data, with 182 (93%) completing 1-year follow-up: 95 of 99 (96%) permanent, 87 of 101 (86%) delayed absorbable. The total rate of mesh or permanent suture exposure was 12 of 198 (6.1%): 5.1% for permanent compared with 7.0% for delayed absorbable (risk ratio 0.73, 95% CI 0.24-2.22). The majority (9/12) were asymptomatic. Composite success was 93% for permanent compared with 95% for delayed absorbable suture, P=.43). Six (3.0%) women had a serious adverse event. CONCLUSION: Suture type used for vaginal graft attachment did not influence mesh or permanent suture exposure rates. FUNDING SOURCE: Boston Scientific Corporation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02277925.