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.

Racial and ethnic disparities in surgical care for endometriosis across the United States.

BACKGROUND: Despite an estimated 10% prevalence of endometriosis among reproductive-age women, surgical population-based data are limited. OBJECTIVE: We sought to investigate racial and ethnic disparities in surgical interventions and complications among patients undergoing endometriosis surgery across the United States. STUDY DESIGN: We performed a retrospective cohort study of American College of Surgeons National Surgical Quality Improvement Program data from 2010 to 2018 identifying International Classification of Diseases, Ninth/Tenth Revision codes for endometriosis We compared procedures, surgical routes (laparoscopy vs laparotomy), and 30-day postoperative complications by race and ethnicity. RESULTS: We identified 11,936 patients who underwent surgery for endometriosis (65% White, 8.2% Hispanic, 7.3% Black or African American, 6.2% Asian, 1.0% Native Hawaiian or Pacific Islander, 0.6% American Indian or Alaska Native, and 11.5% of unknown race). Perioperative complications occurred in 9.6% of cases. After adjusting for confounders, being Hispanic (adjusted odds ratio, 1.31; 95% confidence interval, 1.06-1.64), Black or African American (adjusted odds ratio, 1.71; confidence interval, 1.39-2.10), Native Hawaiian or Pacific Islander (adjusted odds ratio, 2.08; confidence interval, 1.28-3.37), or American Indian or Alaska Native (adjusted odds ratio, 2.34; confidence interval, 1.32-4.17) was associated with surgical complications. Hysterectomies among Hispanic (adjusted odds ratio, 1.68; confidence interval, 1.38-2.06), Black or African American (adjusted odds ratio, 1.77; confidence interval, 1.43-2.18), Asian (adjusted odds ratio, 1.87; confidence interval, 1.43-2.46), Native Hawaiian or Pacific Islander (adjusted odds ratio, 4.16; confidence interval, 2.14-8.10), and patients of unknown race or ethnicity (adjusted odds ratio, 2.07; confidence interval, 1.75-2.47) were more likely to be open. Being Hispanic (adjusted odds ratio, 1.64; confidence interval, 1.16-2.30) or Black or African American (adjusted odds ratio, 2.64; confidence interval, 1.95-3.58) was also associated with receipt of laparotomy for nonhysterectomy procedures. The likelihood of undergoing oophorectomy was increased for Hispanic and Black women (adjusted odds ratio, 2.57; confidence interval, 1.96-3.37 and adjusted odds ratio, 2.06; confidence interval, 1.51-2.80, respectively), especially at younger ages. CONCLUSION: Race and ethnicity were independently associated with surgical care for endometriosis, with elevated complication rates experienced by Hispanic, Black or African American, Native Hawaiian or Pacific Islander, and American Indian or Alaska Native patients.

Clobetasol Compared With Fractionated Carbon Dioxide Laser for Lichen Sclerosus: A Randomized Controlled Trial.

OBJECTIVE: To compare 6-month safety and efficacy outcomes of fractionated CO2 laser (laser) with topical clobetasol propionate (steroid) for treatment of symptomatic vulvar lichen sclerosus. METHODS: We conducted a single-center randomized controlled trial that compared fractionated CO2 laser with steroid treatment for patients with biopsy-proven lichen sclerosus. Randomization was stratified by prior clobetasol propionate use. The primary outcome was mean change in Skindex-29 score at 6 months. A total sample size of 52 participants were recruited to detect a mean difference of 16 points on the Skindex-29 (SD±22) with 80% power, based on a one-sided two-sample t test with α=0.05, accounting for 10% attrition. Secondary outcomes included validated subjective and objective measures. Intention-to-treat, per protocol, and regression analysis based on prior steroid exposure were performed. RESULTS: From October 2015 to July 2018, 202 women were screened, 52 were randomized, and 51 completed a 6-month follow-up. No significant difference was found in baseline demographics, symptoms, and physician assessment scores. There was greater improvement in the Skindex-29 score in the laser arm at 6-months (10.9 point effect size, 95% CI 3.42-18.41; P=.007). Overall, 89% (23/27) of patients in the laser group rated symptoms as being "better or much better" compared with 62% (13/24) of patients in the steroid group, P=.07. More patients (81%, 21/27) were "satisfied or very satisfied" with laser treatment compared with steroid treatment (41%, 9/24); P=.01. After stratification for previous steroid use, the significant change of Skindex-29 score was only seen in the previously exposed group. There was one adverse event in each group: minor burning and blistering at the laser site and reactivation of genital herpes 1 week after starting steroid. CONCLUSION: Fractionated CO2 laser treatment showed significant improvement in subjective symptoms and objective measures compared with clobetasol propionate, without serious safety or adverse events at 6 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02573883.

Physical Activity, Diet, and Incident Urinary Incontinence in Postmenopausal Women: Women's Health Initiative Observational Study.

BACKGROUND: Physical activity and macronutrient intake, important contributors to energy balance, may be independently associated with female urinary incontinence (UI). METHODS: We evaluated the association of baseline self-reported physical activity and macronutrient intake, via food frequency questionnaire, with incident UI subtypes after 3 years among 19 741 postmenopausal women in the Women's Health Initiative Observational Study. Odds ratios (ORs) for incident urgency, stress, and mixed UI were calculated using multivariable logistic regression. RESULTS: Women who reported total physical activity (metabolic equivalent task [MET]-hours/week) ≥30 versus <0.1 were 16% less likely to develop urgency UI (OR = 0.84; 95% CI 0.70, 1.00) and 34% less likely for mixed UI (OR = 0.66; 95% CI 0.46, 0.95), although linear trends were no longer statistically significant after adjusting for baseline weight and weight change (p trend = .15 and .16, respectively). The association between physical activity and incident stress UI was less consistent. Higher uncalibrated protein intake was associated with increased odds of incident urgency UI (≥19.4% vs <14.1% of energy intake OR = 1.14; 95% CI 0.99, 1.30; p trend = .02), while CIs were wide and included 1.0 for calibrated protein intake. Other macronutrients were not associated with urgency UI and macronutrient intake was not associated with incident stress or mixed UI (p trend > .05 for all). CONCLUSIONS: Among postmenopausal women, higher physical activity was associated with lower risk of incident urgency and mixed UI, but not stress UI, independent of baseline weight and weight change. Higher protein intake was associated with increased risk of urgency UI, but no associations were observed between other macronutrient and UI subtypes.

#UTOPia: Urogynecology Tag Ontology Project.

OBJECTIVE: The objective of this study was to review and analyze the current social media status of urogynecology/female pelvic medicine and reconstructive surgery on Twitter and create a tag ontology. METHODS: A "tag ontology" is a standardized list of hashtags used to organize specific subject matter within a social media platform. We used an online social media analytics tool, Symplur to identify tweets and hashtags related to #urogynecology between January 2018 and July 2020. Hashtags identified using Symplur were verified manually via Twitter inquiries and reviewed by urogynecology social medial influencers for external validation. The hashtags were selected based on frequency of use, social media influencer opinion, and clinical relevance. RESULTS: We identified 6,847 tweets and 2,946 users. Our ontology includes 67 terms categorized into 5 groups (urinary, prolapse, anus/rectum, vulva, and other). Using "Symplur Rank," the 2 top influencers included @FPMRS and @FPMRSJournal. CONCLUSIONS: Adaptation of a standardized hashtag ontology facilitates communication between providers and patients about pertinent health care issues. Our study has created a urogynecology-specific ontology based on 2018-2020 Twitter usage.

Association of Pelvic Organ Prolapse Quantification examination D point with uterosacral ligament suspension outcomes: the "OPTIMAL" D point.

INTRODUCTION AND HYPOTHESIS: The objective was to determine the relationship between the preoperative D-point and apical outcomes at 24 months, using the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) dataset. METHODS: This was a secondary analysis of the OPTIMAL trial, a randomized multi-centered study comparing outcomes of sacrospinous ligament fixation and transvaginal uterosacral ligament suspension (USLS). The 2-year dataset utilized included women undergoing USLS with concomitant hysterectomy. The primary outcome was the relationship between preoperative D-point and apical outcomes at 24 months. Secondary objectives were to determine the relationship between preoperative D-point and anatomical, composite and subjective outcomes, and to determine a D-point cut-off that could be used to predict success in each of these categories. RESULTS: Of the 186 women in the USLS arm, 120 were available for analysis of anatomical failure at 24 months. A higher preoperative D-point correlated with improved apical outcome (C-point) at 24 months (r = 0.34; p value = 0.0002). Using ROC curves, a moderate association was found between the preoperative D-point and apical and anatomical success, (AUC 0.689 and 0.662). There was no relationship between preoperative D-point and composite or subjective success (AUC 0.577 and 0.458). Based on the ROC curves, a "cut-off" D-point value of -4.25 cm (sensitivity = 0.58, specificity = 0.67) was determined to be a predictor of postoperative anatomical success at 2 years. CONCLUSIONS: Preoperative D-point correlates with postoperative anatomical and apical support, but is less successful at predicting subjective outcomes. The strongest predictive D-point cut-off for anatomical and apical success at 24 months was -4.25 cm.

Enhanced Recovery and Surgical Optimization Protocol for Minimally Invasive Gynecologic Surgery: An AAGL White Paper.

This is the first Enhanced Recovery After Surgery (ERAS) guideline dedicated to standardizing and optimizing perioperative care for women undergoing minimally invasive gynecologic surgery. The guideline was rigorously formulated by an American Association of Gynecologic Laparoscopists Task Force of US and Canadian gynecologic surgeons with special interest and experience in adapting ERAS practices for patients requiring minimally invasive gynecologic surgery. It builds on the 2016 ERAS Society recommendations for perioperative care in gynecologic/oncologic surgery by serving as a more comprehensive reference for minimally invasive endoscopic and vaginal surgery for both benign and malignant gynecologic conditions. For example, the section on preoperative optimization provides more specific recommendations derived from the ambulatory surgery and anesthesia literature for the management of anemia, hyperglycemia, and obstructive sleep apnea. Recommendations pertaining to multimodal analgesia account for the recent Food and Drug Administration warnings about respiratory depression from gabapentinoids. The guideline focuses on workflows important to high-value care in minimally invasive surgery, such as same-day discharge, and tackles controversial issues in minimally invasive surgery, such as thromboprophylaxis. In these ways, the guideline supports the American Association of Gynecologic Laparoscopists and our collective mission to elevate the quality and safety of healthcare for women through excellence in clinical practice.

Exploring the Point-of-Sale Among Vape Shops Across the United States: Audits Integrating a Mystery Shopper Approach.

INTRODUCTION: Vape shops represent prominent, unique retailers, subject to Food and Drug Administration (FDA) regulation in the United States. AIMS AND METHODS: This study assessed compliance of US vape shop retail marketing strategies with new regulations (eg, required age verification, prohibited free samples) and pre-implementation conditions for other regulations (eg, health warning labels on all nicotine products, required disclosures of e-liquid contents). RESULTS: 95.0% of shops displayed minimum-age signage; however, mystery shoppers were asked for age verification at 35.6% upon entry and at 23.4% upon purchase. Although 85.5% of shops had some evidence of implementing FDA health warnings, 29.1% had signage indicating prohibited health claims, 16.3% offered free e-liquid samples, 27.4% had signage with cartoon imagery, and 33.3% were within two blocks of schools. All shops sold open-system devices, 64.8% sold closed-system devices, 68.2% sold their own brand of e-liquids, 42.5% sold e-liquids containing cannabidiol, 83.2% offered price promotions of some kind, and 89.9% had signage for product and price promotions. CONCLUSIONS: Results indicated that most shops complied with some implementation of FDA health warnings and with free sampling bans and minimum-age signage. Other findings indicated concerns related to underage access, health claims, promotional strategies, and cannabidiol product offerings, which call for further FDA and state regulatory/enforcement efforts.

Initial use of tobacco or marijuana and later use profiles in young adults.

INTRODUCTION: Given the relatively limited literature regarding risk factors for progression of alternative tobacco and marijuana use, this study examined initially-used tobacco or marijuana products and psychosocial risk factors such as adverse childhood events (ACEs), mental health (depression, ADHD), and parental substance use, in relation to young adult lifetime and current (past 30-day) tobacco and marijuana use. METHODS: Using cross-sectional data from a 2014-2016 study of 3418 young adult college students in Georgia, we analyzed lifetime and current use of various tobacco products (cigarettes, cigar products, smokeless tobacco, e-cigarettes, hookah) and marijuana among lifetime tobacco or marijuana users (N=1451) in relation to initially-used product as well as sociodemographic characteristics and psychosocial risk factors. RESULTS: Multivariable analyses indicated that more products ever used correlated with cigarettes being first used (vs cigars, B=-0.66; e-cigarettes, OR=-1.33; hookah, B=-0.99; and marijuana, B=-1.05; p<0.001), as well as being older (B=0.06), male (B=-0.72) and White (vs Black, B=-0.30; or Asian, B=-0.60), more adverse childhood events (ACEs, B=0.07), and parental marijuana use (B=0.47; p<0.05). Currently-used products correlated with cigarettes being first used (vs cigars, B=-0.18; e-cigarettes, B=-0.37; and hookah, B=-0.18; p<0.05), being younger (B=-0.04), male (B=-0.15), more depressive symptoms (B=0.01), and parental marijuana use (B=0.40; p<0.05). Current cigarette, smokeless tobacco, hookah and marijuana use demonstrated specificity to initially-used products. CONCLUSIONS: Initially-used products, specifically cigarettes, with well-documented and communicated risks, correlated with using more products subsequently among young adults, underscoring needed research on such risks and risk communication, and early intervention strategies.

Vape shop identification, density and place characteristics in six metropolitan areas across the US.

Vaping is increasingly prevalent and controversial. Vape shops and convenience stores are common but distinct sources of vaping products, and where they locate may reflect likely target markets. This study examined the density and neighborhood demographics of vape shops and convenience stores in six metropolitan statistical areas (MSAs): Atlanta, Boston, Minneapolis, Oklahoma City, San Diego, Seattle. We identified 459 vape shops using Yelp and Google application programming interfaces and 10,777 convenience stores using ReferenceUSA and Dun & Bradstreet. Retailers were geocoded to census tracts (n = 4,442), and logistic regressions were conducted using as predictors percent non-White, percent youth (5-17 years or 5-20 years), and median household income from the American Community Survey, 2013-2017. Per 10,000 young adults, vape shop density ranged from 0.6 (Boston, San Diego) to 1.7 (Oklahoma City), and convenience store density ranged from 12.6 (San Diego) to 26.3 (Oklahoma City). Logistic regressions indicated that vape shops more likely resided in tracts with lower percentages of youth in Boston, but higher percentages of youth in Atlanta, as well as with lower incomes in Boston and Seattle. Convenience stores more likely resided in tracts with lower percentages of non-Whites in Atlanta and Boston; lower incomes in Atlanta, Boston, San Diego, and Seattle; and higher percentages of youth in Atlanta, Boston, and Minneapolis. These common retail sources of vaping products differentially locate in relation to neighborhood sociodemographics across MSAs. Findings suggest that, in some MSAs, vape shops and convenience stores may target youth and lower income populations.

Admixture mapping of pelvic organ prolapse in African Americans from the Women's Health Initiative Hormone Therapy trial.

Evidence suggests European American (EA) women have two- to five-fold increased odds of having pelvic organ prolapse (POP) when compared with African American (AA) women. However, the role of genetic ancestry in relation to POP risk is not clear. Here we evaluate the association between genetic ancestry and POP in AA women from the Women's Health Initiative Hormone Therapy trial. Women with grade 1 or higher classification, and grade 2 or higher classification for uterine prolapse, cystocele or rectocele at baseline or during follow-up were considered to have any POP (N = 805) and moderate/severe POP (N = 156), respectively. Women with at least two pelvic exams with no indication for POP served as controls (N = 344). We performed case-only, and case-control admixture-mapping analyses using multiple logistic regression while adjusting for age, BMI, parity and global ancestry. We evaluated the association between global ancestry and POP using multiple logistic regression. European ancestry at the individual level was not associated with POP risk. Case-only and case-control local ancestry analyses identified two ancestry-specific loci that may be associated with POP. One locus (Chromosome 15q26.2) achieved empirically-estimated statistical significance and was associated with decreased POP odds (considering grade ≥2 POP) with each unit increase in European ancestry (OR: 0.35; 95% CI: 0.30, 0.57; p-value = 1.48x10-5). This region includes RGMA, a potent regulator of the BMP family of genes. The second locus (Chromosome 1q42.1-q42.3) was associated with increased POP odds with each unit increase in European ancestry (Odds ratio [OR]: 1.69; 95% confidence interval [CI]: 1.28, 2.22; p-value = 1.93x10-4). Although this region did not reach statistical significance after considering multiple comparisons, it includes potentially relevant genes including TBCE, and ACTA1. Unique non-overlapping European and African ancestry-specific susceptibility loci may be associated with increased POP risk.

Defining Cervical Elongation: A Prospective Observational Study.

OBJECTIVES: Our primary aim was to define cervical elongation (CE) using the following methods: (1) measurement of pathology specimen, (2) physician perception, (3) intraoperative estimate of anterior cervical length, and (4) office Pelvic Organ Prolapse Quantification (POP-Q) points C and D. Our secondary aim was to determine whether these definitions correlate with perioperative outcomes. METHODS: Women undergoing vaginal hysterectomy and prolapse repair were enrolled. Office POP-Q measurements were collected. Estimates of cervical length were made based on points C minus D of the POP-Q and by manual exam using the surgeon's index and middle fingers. Cervical dimensions were measured from the pathology specimen at the end of the case. CE was defined as one standard deviation (SD) above the mean for each definition. Additional intraoperative data was collected to determine the surgeon perception of cervical anatomy. RESULTS: A total of 90 patients were enrolled during the study period. Our definitions for CE were as follows: (1) 5 cm (70 without and 20 with CE), (2) physician perception (67 without and 23 with CE), (3) 3.4 cm (79 without and 11 with CE), and (4) 8.3 cm (77 without and 13 with CE). After controlling for uterine weight and the presence of fibroids, the operative time was the only outcome measure that remained elevated for patients with CE using our first definition (42.4 ± 20.1 without vs. 53.8 ± 19.2 with CE, P = 0.03). CONCLUSIONS: CE using our first definition was associated with a statistically significant increase in operative time in women undergoing hysterectomy at the time of prolapse repair.

Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study.

BACKGROUND: There is growing interest in uterine conservation at the time of surgery for uterovaginal prolapse, but limited data compare different types of hysteropexy. OBJECTIVE: We sought to compare 1-year efficacy and safety of laparoscopic sacral hysteropexy and vaginal mesh hysteropexy. STUDY DESIGN: This multicenter, prospective parallel cohort study compared laparoscopic sacral hysteropexy to vaginal mesh hysteropexy at 8 institutions. We included women ages 35-80 years who desired uterine conservation, were done with childbearing, and were undergoing 1 of the above procedures for stage 2-4 symptomatic anterior/apical uterovaginal prolapse (anterior descent at or beyond the hymen [Aa or Ba ≥ 0] and apical descent at or below the midvagina [C ≥ -TVL/2]). We excluded women with cervical elongation, prior mesh prolapse repair, cervical dysplasia, chronic pelvic pain, uterine abnormalities, and abnormal bleeding. Cure was defined as no prolapse beyond the hymen and cervix above midvagina (anatomic), no vaginal bulge sensation (symptomatic), and no reoperations. Pelvic Organ Prolapse Quantification examination and validated questionnaires were collected at baseline and 12 months including the Pelvic Floor Distress Inventory Short Form, Female Sexual Function Index, and Patient Global Impression of Improvement. In all, 72 subjects/group were required to detect 94% vs 75% cure (80% power, 15% dropout). Intention-to-treat analysis was used with logistic regression adjusting for baseline differences. RESULTS: We performed 74 laparoscopic sacral hysteropexy and 76 vaginal mesh hysteropexy procedures from July 2011 through May 2014. Laparoscopic patients were younger (P < .001), had lower parity (P = .006), were more likely premenopausal (P = .008), and had more severe prolapse (P = .02). Laparoscopic procedure (174 vs 64 minutes, P < .0001) and total operating time (239 vs 112 minutes, P < .0001) were longer. There were no differences in blood loss, complications, and hospital stay. One-year outcomes for the available 83% laparoscopic and 80% vaginal hysteropexy patients revealed no differences in anatomic (77% vs 80%; adjusted odds ratio, 0.48; P = .20), symptomatic (90% vs 95%; adjusted odds ratio, 0.40; P = .22), or composite (72% vs 74%; adjusted odds ratio, 0.58; P = .27) cure. Mesh exposures occurred in 2.7% laparoscopic vs 6.6% vaginal hysteropexy (P = .44). A total of 95% of each group were very much better or much better. Pelvic floor symptom and sexual function scores improved for both groups with no difference between groups. CONCLUSION: Laparoscopic sacral hysteropexy and vaginal mesh hysteropexy had similar 1-year cure rates and high satisfaction.

Utilizing Technology in Assessment of Lower Urinary Tract Symptoms: A Randomized Trial of Electronic Versus Paper Voiding Diaries.

OBJECTIVES: The aim of this study was to compare a Web app developed by the American Urogynecologic Society, called "BladderTrakHer," to the traditional paper voiding diary (PVD) for reliability and satisfaction. METHODS: Women presenting to our urogynecology practice with lower urinary tract symptom and access to an iPhone/iPad were randomized to a 3-day electronic voiding diary (EVD), using the BladderTrakHer Web app or PVD. Participants then completed a second voiding diary using the alternate format. Estimated fluid intake and output, number of voids, and episodes of incontinence were compared between formats. Patient and practitioner surveys assessed ease of use, ease of data interpretation, time to data entry, and overall satisfaction. RESULTS: Thirty-one of 122 patients completed both diary formats and the survey. The EVD and PVD showed good test-retest reliability. Patients recorded a higher number of entries for both voids and leaks while using the PVD (28.0 vs 25.5 [P = 0.03] and 4.5 vs 2.8 [P = 0.02], respectively). There was no significant difference in time to data entry among diary formats; 51.6% of patients preferred the EVD, and 78% of patients would prefer an electronic format if the app were improved. Four of 6 practitioners found the PVD easier to interpret, but all stated a preference for an EVD if the data were presented in a more organized fashion. CONCLUSIONS: The use of an EVD is acceptable and reliable in our population of adult female patients with lower urinary tract symptom. Electronic voiding diary and PVD have good test-retest reliability, although the number of voids and leaks entered is slightly lower for the EVD.

Does Pelvic Organ Prolapse Quantification Examination D Point Predict Uterosacral Ligament Suspension Outcomes?

OBJECTIVES: The best predictors for postoperative anatomic apical success after transvaginal uterosacral ligament suspension remain unknown. The aim of this study was to determine if there is a correlation between the preoperative D point and anatomic outcomes for apical prolapse after 1 year. METHODS: This retrospective cohort study included subjects undergoing transvaginal uterosacral ligament suspension from 2008 through 2013 who had at least 1 year follow-up. Demographic information, preoperative and postoperative Pelvic Organ Prolapse Quantification (POPQ) examination measurements, need for retreatment or repeat surgery, and assessment of pelvic floor symptoms were reviewed. Postoperative apical success was defined as C point descent no more than one third into the vaginal canal. RESULTS: One hundred twenty-five women met inclusion criteria and had follow-up at 1 year or more. Concomitant procedures included anterior/posterior repair and midurethral sling. Mean follow-up time was 22.8 months (range, 12-63 months). At last follow-up, 96% met criteria for apical success. A more negative preoperative D point was significantly related to improved postoperative apical support, with each 1-cm descent in preoperative D point resulting in a postoperative C point that was 0.21 cm lower (P = 0.0005). Based on the receiver operating characteristic curve, a "cutoff" D point value of -4.25 (sensitivity, 0.8; specificity, 0.65) was determined to be a predictor of postoperative apical success at 1 year or more. CONCLUSIONS: The preoperative D point correlates with postoperative apical support, and a clinically meaningful relationship exists between the preoperative D point and anatomic apical success.

Transvaginal Versus Transabdominal Placement of Synthetic Mesh at Time of Sacrocolpopexy.

OBJECTIVES: Our primary aim was to compare mesh-related complications at the time of total vaginal hysterectomy with laparoscopic sacrocolpopexy (TVH-LSC) versus laparoscopic placement of sacrocolpopexy mesh at time of laparoscopic supracervical hysterectomy (LSH-LSC). Our secondary aim was to compare operative time, intraoperative and postoperative complications, as well as subjective and objective success between these groups. METHODS: We performed a retrospective cohort study with prospective follow-up for patients with uterovaginal prolapse who underwent TVH-LSC or LSH-LSC from June 2008 to July 2012. We collected baseline demographics, mesh-related complications, intraoperative and postoperative complications, and pelvic organ prolapse quantification data. We contacted patients postoperatively for telephone interviews and to request a return to the office for repeat examination. RESULTS: One hundred eighty-two patients were included: 123 TVH-LSC and 59 LSH-LSC. There was no difference in the rate of mesh-related complications (1.6% [2/123]; 95% confidence interval, 0-3.86% vs 1.7% [1/59]; 95% confidence interval, 0-4.99%; P = 1.0). Median examination follow-up was similar between groups (9 (2-17) months TVH-LSC vs 9 (2-17) months LSH-LSC, P = 1.0).The TVH-LSC was associated with a significantly shorter operative time (256 ± 53 vs 344 ± 81 minutes; P < 0.01). There were no differences in intraoperative or postoperative complications or subjective and objective success between groups. CONCLUSIONS: There was no difference in mesh-related complications between groups (1.6% TVH-LSC vs 1.7% LSH-LSC; P = 1.0). Vaginal mesh attachment during TVH-LSC decreased operative time by over 1 hour with no differences in intraoperative complications, reoperation for recurrent prolapse, and subjective or objective outcomes compared to LSH-LSC.

Effects of bilateral salpingo-oophorectomy at the time of hysterectomy on pelvic organ prolapse: results from the Women's Health Initiative trial.

OBJECTIVE: This study aims to estimate the effects of bilateral salpingo-oophorectomy (BSO) at the time of hysterectomy and estrogen therapy on vaginal prolapse. METHODS: A retrospective analysis of the Women's Health Initiative estrogen-alone trial was performed. Women who retained their ovaries were compared with women who had BSO at the time of hysterectomy for the presence of cystocele or rectocele at entry into the study. Based on BSO and hormone therapy (HT) status, participants were categorized into groups. We hypothesized that BSO and prolonged hypoestrogenemia may be associated with an increased risk of prolapse. Univariate and multivariate analyses were used to determine the effects of BSO and HT status on cystocele and rectocele. RESULTS: Of 10,739 participants in the estrogen-alone trial, 8,879 women were included in the analysis. Older age, higher parity, higher body mass index, higher waist-to-hip ratio, and non-African-American race/ethnicity were associated with increased odds of developing cystocele or rectocele. Women who retained their ovaries had higher rates of cystocele or rectocele at screening (39%) compared with all women who had BSO (31-36%; odds ratio, 1.18; 95% CI, 1.04-1.33). After controlling for multiple variables, our analysis showed that women who retained their ovaries had higher odds of developing cystocele or rectocele compared with women who had BSO and no subsequent HT (odds ratio, 1.23; 95% CI, 1.07-1.41). All other comparisons were nonsignificant. CONCLUSIONS: BSO at the time of hysterectomy is not associated with increased risk of cystocele or rectocele. BSO and no subsequent HT may even have a protective effect against cystocele or rectocele.

Vaginal dilators for prevention of dyspareunia after prolapse surgery: a randomized controlled trial.

OBJECTIVE: To compare rates of de novo dyspareunia in women with and without vaginal dilator use after posterior colporrhaphy. METHODS: This randomized controlled trial included sexually active patients with prolapse and no bothersome baseline dyspareunia undergoing posterior colporrhaphy. Patients were randomized to daily vaginal dilator use from postoperative weeks 4 through 8 or to no dilator use. Pelvic organ prolapse quantification examination and vaginal caliber were measured at baseline, 8 weeks, and 6 months postoperatively. Sexual function was evaluated at baseline, 3 months, and 6 months postoperatively using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12. Participants completed a Patient Global Impression of Improvement at 3 months and 6 months postoperatively. RESULTS: Sixty patients were randomized: 30 in the dilator group and 30 in the control group. There were no differences in baseline characteristics and postoperative vaginal caliber between groups. At 3 months, 9.5% of patients reported de novo dyspareunia in the dilator group compared with 19.2% of control patients (P=.44). At 6 months, 12.5% of patients in the dilator group reported de novo dyspareunia compared with 3.8% of control patients (P=.34). There was a 13% loss-to-follow-up rate, and therefore we did not meet appropriate power to detect a difference. There were no differences in overall sexual function or Patient Global Impression of Improvement scores between groups at 3 months and 6 months. CONCLUSION: There were no significant differences in de novo dyspareunia rates, overall postoperative sexual function scores, or global improvement scores between those using vaginal dilators compared with control patients.

A randomized trial comparing conventional and robotically assisted total laparoscopic hysterectomy.

OBJECTIVE: The purpose of this study was to compare operative time and intra- and postoperative complications between total laparoscopic hysterectomy and robotic-assisted total laparoscopic hysterectomy. STUDY DESIGN: This study was a blinded, prospective randomized controlled trial conducted at 2 institutions. Subjects consisted of women who planned laparoscopic hysterectomy for benign indications. Preoperative randomization to total laparoscopic hysterectomy or robotic-assisted total laparoscopic hysterectomy was stratified by surgeon and uterine size (> or ≤12 weeks). Validated questionnaires, activity assessment scales, and visual analogue scales were administered at baseline and during follow-up evaluation. RESULTS: Sixty-two women gave consent and were enrolled and randomly assigned; 53 women underwent surgery (laparoscopic, 27 women; robot-assisted, 26 women). There were no demographic differences between groups. Compared with laparoscopic hysterectomy, total case time (skin incision to skin closure) was significantly longer in the robot-assisted group (mean difference, +77 minutes; 95% confidence interval, 33-121; P < .001] as was total operating room time (entry into operating room to exit; mean difference, +72 minutes; 95% confidence interval, 14-130; P = .016). Mean docking time was 6 ± 4 minutes. There were no significant differences between groups in estimated blood loss, pre- and postoperative hematocrit change, and length of stay. There were very few complications, with no difference in individual complication types or total complications between groups. Postoperative pain and return to daily activities were no different between groups. CONCLUSION: Although laparoscopic and robotic-assisted hysterectomies are safe approaches to hysterectomy, robotic-assisted hysterectomy requires a significantly longer operative time.