Prevalence of Lower Urinary Tract Symptoms in Women Planning to Undergo Hysterectomy for Uterine Leiomyoma and Abnormal Uterine Bleeding.

Introduction: Leiomyomas are associated with lower urinary tract symptoms (LUTS), but more specific characterization of their impact on LUTS is needed. Methods: This is a retrospective cohort study of 202 participants (101 per group) who underwent hysterectomy for leiomyomas versus abnormal uterine bleeding nonclassified (AUB-N) from July 2015 to May 2019. Baseline demographics, leiomyoma characteristics, and presence of baseline LUTS were collected. The main objective was to compare the prevalence of LUTS between these two groups. Secondary objectives were to analyze the association between leiomyoma characteristics and the prevalence of LUTS. Results: There was no difference in baseline prevalence of LUTS between the hysterectomy for leiomyoma versus AUB-N groups (42.6% vs. 45.5%, p = 0.67). When examining the entire study cohort of participants, irrespective of hysterectomy indication, leiomyoma size >6 cm was associated with an increased prevalence of LUTS when compared with leiomyoma <6 cm (64.9% vs. 40.4%, p = 0.02), and specifically difficulty passing urine (p = 0.02), nocturia (p = 0.04), and urinary frequency (p = 0.04). When controlling for age, body mass index, parity, chronic pelvic pain, and diabetes, leiomyomas >6 cm remained significantly associated with the presence of LUTS (odds ratio 3.1, 95% confidence interval = 1.2-8.3) when compared with leiomyoma <6 cm. Presence of >1 leiomyoma was associated with urinary frequency (67.9% vs. 32.1%, p = 0.02) when compared with ≤1 leiomyoma. Anterior location and uterine volume were not associated with a difference in LUTS. Conclusion: LUTS are prevalent in those planning hysterectomy for leiomyoma and AUB-N. Leiomyomas >6 cm are associated with the presence of LUTS. Future studies should evaluate change in LUTS following hysterectomy for leiomyomas.

Long-Term Mesh Exposure 5 Years Following Minimally Invasive Total Hysterectomy and Sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: The objective was to assess long-term mesh complications following total hysterectomy and sacrocolpopexy. METHODS: In this second extension study, women from a multicenter randomized trial were followed for more than 36 months after surgery. Owing to COVID-19, participants were assessed through either in-person visits or telephone questionnaires. The primary outcome was the incidence of permanent suture or mesh exposure. Secondary outcomes included surgical success and late adverse outcomes. RESULTS: Out of the 200 initially enrolled participants, 82 women took part in this second extension study. Among them, 46 were in the permanent suture group, and 36 in the delayed absorbable group. The mean follow-up duration was 5.3 years, with the cumulative mesh or suture exposure of 9.9%, involving 18 cases, of which 4 were incident cases. Surgical success after more than 5 years stood at 95%, with few experiencing bothersome bulge symptoms or requiring retreatment. No serious adverse events occurred, including mesh erosion into the bladder or bowel. The most common adverse events were vaginal pain, bleeding, dyspareunia, and stress urinary incontinence, with no significant differences between suture types. CONCLUSION: The study found that mesh exposure risk gradually increased over time, reaching nearly 10% after more than 5 years post-surgery, regardless of suture type. However, surgical success remained high, and no delayed serious adverse events were reported.

A Randomized Clinical Trial: Patient Satisfaction of Paper Versus Electronic Provider Feedback.

IMPORTANCE: Minimal data compare patient satisfaction with completing paper versus electronic evaluations. OBJECTIVES: This study aimed to compare patient satisfaction with completing paper versus electronic evaluations. Secondary objectives were assessing age, education, and socioeconomic status with comfort with technology; preference for evaluation type; and timeliness of completing evaluations. STUDY DESIGN: This was a single-center randomized trial comparing paper versus electronic patient evaluations of health care providers. Study participation occurred at the end of clinic visits. RESULTS: Among 145 participants, 73 (50.3%) were analyzed as paper versus 72 (49.7%) as electronic. Groups were similar in age, race, education level, income, insurance type, technology comfort, and technology use. Groups were similar in finding ease (P = 0.99) and satisfaction (P = 0.76) with their randomized method. For participants randomized to paper, 34% preferred paper, 25% preferred electronic, and 41% had no preference. Electronic feedback took longer to complete (4.5 minutes vs 3.4 minutes, P < 0.001). Older participants took longer to complete the evaluation (4.5 minutes vs 3.2 minutes, P < 0.001), had less internet use (P = 0.01), and were less likely to own a computer (P = 0.03) than younger participants. There were differences by education level for comfort with technology (P = 0.007) and internet use (P = 0.016). There were no differences in ease of feedback completion or satisfaction when comparing age, education status, or income status. CONCLUSIONS: Patients were satisfied with paper and electronic health care provider evaluations, regardless of age or other demographics. Evaluations were completed quickly during visits. Requesting feedback from patients via multiple modalities is feasible in a varied patient population.

Racial and ethnic disparity in national practice patterns for stress urinary incontinence surgery.

INTRODUCTION AND HYPOTHESIS: There is a paucity of information assessing whether race/ethnicity is associated with differences in surgical treatment of stress urinary incontinence (SUI). The primary objective was to assess for racial/ethnic disparities in SUI surgeries. Secondary objectives were to assess for surgical complication differences and trends over time. METHODS: Using the American College of Surgeons National Surgical Quality Improvement Program database, we conducted a retrospective cohort analysis of patients undergoing SUI surgery from 2010 to 2019. Chi-squared or Fisher's exact test and ANOVA were used for categorical and continuous variables respectively. Breslow day score and multinomial and multiple logistic regression models were used. RESULTS: A total of 53,333 patients were analyzed. Using White race/ethnicity and sling surgery as references, Hispanic patients underwent more laparoscopic surgeries (OR1.17 [CI 1.03, 1.33]) and anterior vesico-urethropexy/urethropexies (OR 1.97 [CI 1.66, 2.34]); Black patients underwent more anterior vesico-urethropexy/urethropexies (OR 1.49 [CI 1.07, 2.07]), abdomino-vaginal vesical neck suspensions (OR 2.19 [CI 1.05-4.55]), and inflatable urethral slings (OR 4.28 [CI 1.23-14.90]). White patients had lower rates of inpatient stay (p < 0.0001) and blood transfusion (p < 0.0001) compared with patients who were Black, indigenous, people of color (BIPOC). Over time, Hispanic and Black patients were more likely to undergo anterior vesico-urethropexy/urethropexies than White patients (RR 2.03:1 [CI 1.72-2.40]) and (RR 1.59 CI [1.15-2.20]) respectively. Adjusting for possible confounders, Hispanic and Black patients had a greater chance of having a nonsling surgery, 37% (p < 0.0001) and 44% (p = 0.0001) greater chances respectively. CONCLUSION: We observed racial/ethnic differences in SUI surgeries. Although causality cannot be proven here, our results confirm previous findings suggesting inequities in care.

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.

"I'm Not Going Home With a Catheter": Patient-Perceived Outcomes Associated With Perioperative Intermittent Catheterization.

IMPORTANCE: Indwelling catheters are a known source of dissatisfaction for postoperative patients. There is a paucity of data describing patient-perceived outcomes associated with the alternative of intermittent self-catheterization (ISC). OBJECTIVES: The aim of this study was to describe patient satisfaction and outcomes associated with ISC after outpatient female pelvic reconstructive surgery. STUDY DESIGN: This was a secondary analysis of a prospective cohort study at an academic tertiary referral center from September 2018 to June 2021. Participants completed preoperative ISC instruction that included an instructional video, 1:1 demonstration with a health care provider, and provision of ISC supplies. Participants were instructed to perform ISC postoperatively until they had 2 consecutive outpatient PVRs less than one-half the voided volume. Participant satisfaction was assessed 2 weeks postprocedure, with adverse events evaluated at 6 weeks. RESULTS: One hundred sixty participants completed preoperative ISC instruction and were included in this analysis. Mean age was 52.1 (SD +/- 11.4) years, mean body mass index was 28.9 (SD +/- 5.8), and mean time from ISC instruction to surgery was 16.4 (SD +/- 15.7) days. Most participants reported no difficulty with ISC (124/160 [78%]) and had high levels of satisfaction (148/151 [98%]). Difficulty performing ISC was not associated with time since ISC instruction ( P = 0.32), difficulty noted at ISC instruction by the health care provider ( P = 0.24), or the duration of ISC instruction ( P = 0.16). On multiple logistic regression, age, body mass index, and prolapse beyond the hymen did not predict difficulty learning or performing ISC. At 6 weeks postprocedure, 22 of 155 participants (14%) endorsed symptoms of a urinary tract infection, and 15 of 160 (9%) had a culture-proven urinary tract infection. CONCLUSIONS: Women undergoing outpatient pelvic reconstructive surgery report ease and satisfaction with ISC.

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.

Rationale and design of a multicenter randomized clinical trial of vestibulodynia: understanding pathophysiology and determining appropriate treatments (vestibulodynia: UPDATe).

BACKGROUND: Limited data are available to establish evidence-based management protocols for vestibulodynia (VBD), a chronic vulvar pain condition that affects approximately 14 million women in the U.S. For the purposes of the study, our group subdivided VBD subtypes that may benefit from different types of treatment: 1) VBD peripheral (VBD-p), characterized by pain localized to the vulvar vestibule and 2) VBD central (VBD-c), characterized by VBD alongside one or more other chronic overlapping pain conditions (e.g. irritable bowel syndrome, temporomandibular disorder, and fibromyalgia syndrome) that affect remote body regions. Here, we describe the rationale and design of an NIH-funded multicenter clinical trial comparing the effectiveness of topical and/or systemic medication for alleviating pain and normalizing pain- relevant biomarkers among women with VBD-p and VBD-c. METHODS: Participants will be randomly assigned to one of four parallel arms: peripheral treatment with 5% lidocaine + 0.5 mg/ml 0.02% oestradiol compound cream + oral placebo pill, 2) central treatment with the tricyclic antidepressant nortriptyline + placebo cream, 3) combined peripheral cream and central pill treatments, or 4) placebo cream and placebo pill. The treatment phase will last 16 weeks, with outcome measures and biomarkers assessed at 4 time points (0, 8, 16, and 24 weeks). First, we will compare the efficacy of treatments in alleviating pain using standardized tampon insertion with a numeric rating scale and self-reported pain on the short form McGill Pain Questionnaire. Next, we will compare the efficacy of treatments in improving perceived physical, mental, and sexual health using standardized questionnaires. Finally, we will measure cytokines and microRNAs in local vaginal and circulating blood samples using multiplex assays and RNA sequencing, and determine the ability of these biomarkers to predict treatment response. CONCLUSION: This is the first multicenter randomized controlled trial to evaluate the efficacy of peripherally and centrally acting medications currently used in clinical practice for treating unique VBD subtypes based on distinct clinical and biological signatures. ADMINISTRATIVE INFORMATION: Vestibulodynia UPDATe is a multi-centre, two-by-two factorial designed randomized, double-blind, placebo-controlled trial registered at clinical trials.gov (NCT03844412). This work is supported by the R01 HD096331 awarded to Drs. Nackley, Rapkin, Geller and Carey by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).Key messagesPeripheral lidocaine and oestradiol and centrally-targeted nortriptyline medications are used for the treatment of pain in women with VBD, but there is a lack of data from well-powered RCTs.This two-by-two factorial RCT will test the efficacy of these medications in VBD subtypes characterized by distinct clinical characteristics and biomarker profiles.We hope that results will provide clinicians with scientific evidence of therapeutic efficacy in distinct VBD subtypes in an effort to direct and optimize treatment approaches.

Accuracy of Visual Assessment of Urimeter Bag Volumes: The Whiz Quiz.

IMPORTANCE: Although visual estimate of urine output via urimeter bag is common, data on accuracy are limited. OBJECTIVE: This study aimed to assess the accuracy of a visual estimate of urine output in standard urimeter bags by health care workers. STUDY DESIGN: This is a prospective observational study. Perioperative health care workers were asked to visually estimate fluid volumes in 5 standard urimeter bags. Actual volumes were 50, 150, 350, 500, and 750 mL. Visual estimates were recorded. The primary outcome was accuracy, defined as estimated visual volume within 20% of actual volume. Secondary outcomes included effect of health care provider type, specialty, experience, sex, and age on accuracy. RESULTS: A total of 159 responses were analyzed. There were 55 (35.3%) registered nurses, 19 (12.2%) certified registered nurse anesthetists, 18 (11.5%) advanced practice providers not identified as a certified registered nurse anesthetist, and 64 (41%) physicians. Mean estimated volumes (in milliliters) ± standard deviation and accuracy for the bags were as follows: (a) actual volume of 50 mL and estimated volume of 66 ± 29 mL (45% accuracy), (b) actual volume of 150 mL and estimated volume of 149 ± 43 mL (46% accuracy), (c) actual volume of 350 mL and estimated volume of 356 ± 74 mL (76% accuracy), (d) actual volume of 500 mL and estimated volume of 452 ± 77 mL (85% accuracy), and (e) actual volume of 750 mL and estimated volume of 675 ± 108 mL (85% accuracy). There was reasonable accuracy for individual volume estimates, but accuracy across all 5 urimeter bags was low: 22 of 159 (13.8%). There were no significant differences in accuracy based on health care provider type, specialty, experience, sex, or age. CONCLUSIONS: Consistent accuracy of visual assessment of calibrated urimeter bag volumes was low and not influenced by health care provider characteristics.

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.

Vaginal repair of vesicovaginal fistula: comparison of national practice patterns by surgeon specialty.

INTRODUCTION AND HYPOTHESIS: There are limited data comparing patient and operative characteristics for vaginal repair of vesicovaginal fistula (VVF) by surgeon specialty. Our objective was to compare national practice patterns by surgeon specialty for vaginal repair of VVF. METHODS: Using the American College of Surgeons National Surgical Quality Improvement Program database, we conducted a retrospective cohort analysis of women who underwent vaginal repair of VVF from 2010 to 2019. Demographic and perioperative characteristics were compared by surgeon specialty. RESULTS: A total of 252 women were analyzed. Urologists performed 57% of cases (n=144), gynecologists performed 38% (n=96), and general surgeons performed 5% (n=12). There were differences among surgeon specialties in patient characteristics including age (p=0.002), creatinine (p=0.002), hypertension (p=0.02), morbidity probability (p<0.001), hospital stay (p<0.001), inpatient status (p=0.03). Urologists were more likely than gynecologists to use grafts/flaps (p=0.002). There were trending differences among surgeon specialties in patient race (p=0.07) and ethnicity (p=0.06). Urologists and gynecologists were more likely to operate on younger, healthier patients with differences in racial populations. When directly comparing urologists with gynecologists, there were differences in race (p=0.05) and a trending difference in ethnicity (p=0.06), General surgeons were more likely to operate on older white women with worse health status, more concomitant procedures, and longer hospital stay. CONCLUSIONS: Urologists, gynecologists, and general surgeons perform vaginal repair of VVF. Among these specialties, there were differences in patient and perioperative characteristics. This information may help referring providers and patients to understand which types of surgical providers most commonly manage VVF.

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.

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.

Effect of BMI on clinical outcomes following minimally invasive sacrocolpopexy.

Our objective was to compare success and complication rates following minimally invasive sacrocolpopexy (SCP) based on body mass index (BMI). This is a retrospective cohort study of women who underwent laparoscopic or robotic SCP at one academic center from 2006 to 2016. Women were included if they had a postoperative pelvic organ prolapse quantification (POPQ) exam and subjective success documented. For our primary outcome, we compared composite success (POPQ stage ≤ I and report of no bulge symptoms) amongst three groups: normal weight (BMI ≤ 25), overweight (BMI 25-30) and obese (BMI ≥ 30) women. Secondary outcomes included intraoperative complications, 6 week postoperative complications, and sacrocolpopexy mesh exposure. Of the 431 women who met inclusion criteria, 140 (32%) had normal BMI (23 kg/m2; IQR 22, 24), 177 (41%) were overweight (27 kg/m2; IQR 26, 28), and 114 (26%) were obese (32 kg/m2; IQR 31, 36). Mean age was 60 ± 11 years, and most were Caucasian, with no differences in demographics or Charlson Comorbidity Index (CCI). Median length of follow-up was 49 weeks (IQR 9, 104), with similar follow-up for all groups. For our primary outcome, composite success was 72% overall, with no significant differences in composite success rates between groups. For secondary outcomes, there were no differences in the rates of perioperative complications but obese women had a 2.8 increased risk of mesh exposure (p = 0.02). Obesity was not associated with differences in the success or peri-operative complication rates for SCP in our population, but was associated with mesh exposure.

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.

The Impact of Age on Perioperative Complications After Minimally Invasive Sacrocolpopexy.

OBJECTIVE: Our aim was to compare perioperative complications between older (≥65 years), middle-age (55-64 years), and younger (<55 years) women after minimally invasive sacrocolpopexy (SCP). METHODS: This retrospective cohort study included women undergoing SCP from 2006 to 2016 at a single academic center. Our primary outcome was the rate of perioperative complications (intraoperative and postoperative within 6 weeks of surgery), between groups. Secondary outcomes included readmission and reoperation rates. RESULTS: There were 440 consecutive participants: 159 (36.1%) older, 160 (36.4%) middle-age, and 121 (27.5%) younger women. The overall intraoperative complication rate from SCP was 9.1%, with the most common being cystotomy (5.0%) and vaginotomy (1.8%). There were no differences in intraoperative complications between groups. Urinary tract infection (10.9%) and port-site cellulitis (3.4%) were the most common postoperative complications. For our primary outcome, younger women had a higher rate of postoperative complications compared with middle-age and older women (P < 0.001). There was no difference in postoperative complications between older and middle-aged women. In a multivariate regression controlling for comorbidity, body mass index, diabetes, smoking status, concomitant hysterectomy, and/or sling, younger women retained a higher rate of postoperative complications (odds ratio, 1.7 [1.2,2.2]). Rates of readmission (3.2%) and reoperation (0.7%) were also similar between groups. CONCLUSIONS: The rate of perioperative complications was low with no difference in intraoperative complications. Women under 55 had a higher rate of postoperative complications compared to women age 55 to 65 years and those older than 65 years. Our results suggest that it is reasonable to offer SCP to women older than 65 years.

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.

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.

Moving On: How Many Women Opt for Surgery After Pessary Use for Prolapse?

OBJECTIVE: Our primary objective was to evaluate the proportion of women who underwent surgery after successful pessary fitting for pelvic organ prolapse (POP). Our secondary objectives were to assess when surgery occurs and to evaluate factors associated with choosing surgery as compared to continuing with a pessary. METHODS: Our study population included women successfully fitted with a pessary for POP 1/1/12 and 12/31/16. We excluded non-English-speaking women and those who used pessary only as a bridge until surgery. We evaluated events occurring after a successful fitting, including whether women (1) continued pessary use, (2) underwent surgery, or (3) discontinued pessary without surgery. Our primary outcome was the proportion of women who opted for surgery after a successful pessary fitting for POP. We also assessed the median time to surgery and compared women who underwent surgery with those who continued with a pessary to assess variables associated with surgery. RESULTS: Of the 444 women with POP who were successfully fitted with a pessary and met inclusion criteria, 137 (31%) ultimately underwent surgery. The median time to surgery was 10 months (interquartile range, 4-18), with 59% having surgery within 1 year, and 89% within 2 years. In a logistic regression analysis controlling for age in decades, advanced POP stage, and Charlson Comorbidity Index, younger age remained significantly associated with surgery (odds ratio, 0.77, 95% confidence interval, 0.62-0.95; P = 0.02). CONCLUSIONS: Among women successfully fitted with a pessary for POP, one third ultimately underwent surgery, with approximately 60% of these women undergoing surgery within the first year and 90% within 2 years.

Lidocaine Use in Vaginal Surgery and Risk of Toxicity.

OBJECTIVES: The primary objective of this study was to compare the amount of lidocaine administered for vaginal reconstruction with versus without hysterectomy. The secondary objective was to assess the risk of lidocaine toxicity. METHODS: This retrospective cohort study compares lidocaine dose in 2 cohorts: women who underwent vaginal hysterectomy with additional vaginal reconstruction (VH + VR) versus those who underwent vaginal reconstruction without hysterectomy (VR only). Total intraoperative lidocaine dose included the intravenous dose from anesthesia and the vaginally injected dose from the surgeon. The risk of toxicity was defined as total dose greater than 7 mg/kg. The primary outcome was the difference in total lidocaine dose for VH + VR versus VR only. RESULTS: Among 372 women included, 140 (37.6%) were in the VH + VR group, and 232 (62.4%) in the VR-only group. For the primary outcome of total lidocaine dose between groups, VH + VR received more total lidocaine than did VR only (228 ± 105 vs 168 ± 78 mg, P < 0.001). This difference was due to the vaginal lidocaine dose (P < 0.001), with no significant difference in the intravenous lidocaine dose (P = 0.68). In a logistic regression model controlling for age, anesthesia type, sling, and anterior repair, posterior repair, and anesthesia type, VH remained an independent risk factor for increased lidocaine dose (P < 0.001). Two women received a toxic dose of lidocaine, and both were in the VH + VR group. CONCLUSIONS: Women undergoing vaginal hysterectomy with additional vaginal reconstructive procedures are more likely to receive a higher dose of lidocaine compared with women undergoing vaginal reconstruction alone. The risk of lidocaine toxicity is increased with concomitant procedures.