A pilot randomized controlled trial of vaginal estrogen on postpartum atrophy, perineal pain, and sexual function.

INTRODUCTION AND HYPOTHESIS: Vulvovaginal symptoms following perineal laceration may be worsened by atrophy related to decreased estrogen. Our objective was to evaluate the effect of local estrogen therapy in this setting. METHODS: We conducted a single-center, pilot, randomized, placebo-controlled trial of local estradiol in primiparous women with a second-degree or greater perineal laceration following a term vaginal delivery. Participants were randomized to twice weekly estradiol or placebo cream from delivery through 3 months postpartum. The primary outcome was a validated measure of vulvovaginal symptoms at 12 weeks postpartum. Secondary outcomes included measures of perineal pain, quality of life, sexual function, ease of use, likelihood of continued use, and adverse events. RESULTS: We planned to enroll 70 women; however, due to human subjects research restrictions related to the COVID-19 pandemic, enrollment was stopped early. A total of 59 women were randomized, 31 to the estradiol group and 28 to the placebo group. Nearly all participants (95%) were followed through 12 weeks with suggestion of marginal improvement in Vulvar Assessment Scale scores [-0.10; 90% CI = (-0.20, 0.01)] in those randomized to estradiol compared to placebo. Local estradiol was not associated with improvement in other measures, and only one non-serious adverse event was observed. CONCLUSIONS: In primiparous women with a perineal laceration, use of local estradiol showed minimal clinical benefit in vulvovaginal atrophy and related symptoms but appears to be acceptable and safe for postpartum use. Larger adequately powered trials enrolling a diverse group of postpartum women are needed to affirm these findings.

Readmissions and perioperative outcomes for same-day versus next-day discharge after prolapse surgery.

INTRODUCTION AND HYPOTHESIS: We aimed to evaluate the safety of same-day discharge (SDD) compared with next-day discharge (NDD) after prolapse surgery on a national level hypothesizing that readmission and complication rates after SDD would not be higher than NDD. METHODS: We performed a retrospective cohort study using the National Surgical Quality Improvement Program database including 2014-2018. Current Procedural Terminology (CPT) codes were used to identify minimally invasive apical suspensions or obliterative procedures. Exclusion criteria were length of stay > 1 day, unrelated concomitant procedures, serious medical comorbidities, American Society of Anesthesiologists (ASA) Class >2, and complication during index admission. The primary outcome was 30-day readmission, and secondary outcomes included 30-day complications. RESULTS: 12,583 were included in analysis. SDD rate was 16.7%. The majority of women were white (91%) with a mean age of 59 years and mean body mass index of 28 kg/m². Medical comorbidities were similar between the SDD and NDD groups. Overall incidence of 30-day readmission was 1.7%. SDD had lower odds of 30-day readmission than NDD (aOR 0.63, 95% CI 0.41-0.98). SDD had lower odds of 30-day complications but this failed to reach statistical significance (aOR 0.67, 95% CI 0.44-1.03). CONCLUSIONS: In this cohort, 30-day readmission and complication rates were not higher after SDD compared to NDD in women undergoing minimally-invasive apical suspension or obliterative procedures. We interpret these findings carefully given study limitations but believe our findings support the safety of SDD after minimally invasive apical suspension or obliterative procedures in a low-risk population.

Evaluating the Quality and Readability of Online Resources for Labiaplasty.

OBJECTIVES: The aim of this study was to evaluate the quality, readability, and accuracy of Web-based information regarding labiaplasty and to characterize the types of Web sites providing this information. METHODS: Investigators used 3 major search engines to query the internet using the search terms labiaplasty, labia reduction, and vaginal rejuvenation. Two validated tools were used to evaluate Web sites: the JAMA benchmark tool and the DISCERN instrument. Three physicians independently reviewed each Web site. Interrater agreement was assessed, and reviewer scores were averaged. Flesch-Kincaid reading ease and Flesch-Kincaid grade level of each site were assessed. Data were analyzed using Stata 14.0 (College Station, TX). RESULTS: Of the 112 Web sites reviewed, 100 Web sites were from North America, 9 from Europe, 2 from Australia, and 1 from Asia. The median score using the JAMA tool was 1.0 (0.33-4.0), indicating low accountability, whereas the median score using the DISCERN tool was 28 (18.7-77) of 80 with higher scores indicating higher quality. Cohen's weighted κ statistic (0.81) demonstrated near perfect agreement among reviewers for DISCERN scores. The median reading level was 11.9 (6.4-19.5). A majority of the Web sites (92) were for-profit businesses or blogs. CONCLUSIONS: The internet enables patients to research sensitive topics and seek answers without worry of social stigma. Online health-related information is a widely used yet poorly studied source of medical information. The majority of Web sites reviewed lack balanced, evidence-based information. Given the wide variation in the quality of information, physicians should guide patients to reputable online resources.

A multicenter retrospective cohort study comparing urethral diverticulectomy with and without pubovaginal sling.

BACKGROUND: Urethral diverticulum is a rare entity and requires a high suspicion for diagnosis based on symptoms and physical exam with confirmation by imaging. A common presenting symptom is stress urinary incontinence (SUI). The recommended treatment is surgical excision with urethral diverticulectomy. Postoperatively, approximately 37% of patients may have persistent and 16% may have de novo SUI. An autologous fascial pubovaginal sling (PVS) placed at the time of urethral diverticulectomy (UD) has the potential to prevent and treat postoperative SUI. However, little has been published about the safety and efficacy of a concomitant pubovaginal sling. OBJECTIVE: The objective of this study was to compare the clinical presentation, outcomes, complications, and diverticulum recurrence rates in women who underwent a urethral diverticulectomy with vs without a concurrent pubovaginal sling. STUDY DESIGN: This multicenter, retrospective cohort study included women who underwent a urethral diverticulectomy between January 1, 2000, and December 31, 2016. Study participants were identified by Current Procedure Terminology codes, and their records were reviewed for demographics, medical or surgical history, symptoms, preoperative testing, concomitant surgeries, and postoperative outcomes. Symptoms, recurrence rates, and complications were compared between women with and without a concomitant pubovaginal sling. The primary outcome was the presence of postoperative stress urinary incontinence symptoms. Based on a stress urinary incontinence rate of 50% with no pubovaginal sling and 10% with a pubovaginal sling, we needed a sample size of 141 participants who underwent diverticulectomy without a pubovaginal sling and 8 participants with a pubovaginal sling to achieve 83% power with P<.05. RESULTS: We identified 485 diverticulectomy cases from 11 institutions who met the inclusion criteria; of these, 96 (19.7%) cases had a concomitant pubovaginal sling. Women with a pubovaginal sling were older than those without a pubovaginal sling (53 years vs 46 years; P<.001), and a greater number of women with pubovaginal sling had undergone diverticulectomy previously (31% vs 8%; P<.001). Postoperative follow-up period (14.6±26.9 months) was similar between the groups. The pubovaginal sling group had greater preoperative stress urinary incontinence (71% vs 33%; P<.0001), dysuria (47% vs 30%; P=.002), and recurrent urinary tract infection (49% vs 33%; P=.004). The addition of a pubovaginal sling at the time of diverticulectomy significantly improved the odds of stress urinary incontinence resolution after adjusting for prior diverticulectomy, prior incontinence surgery, age, race, and parity (adjusted odds ratio, 2.27; 95% confidence interval, 1.02-5.03; P=.043). It was not significantly protective against de novo stress urinary incontinence (adjusted odds ratio, 0.86; 95% confidence interval, 0.25-2.92; P=.807). Concomitant pubovaginal sling increased the odds of postoperative short-term (<6 weeks) urinary retention (adjusted odds ratio, 2.5; 95% confidence interval, 1.04-6.22; P=.039) and long-term urinary retention (>6 weeks) (adjusted odds ratio, 6.98; 95% confidence interval, 2.20-22.11; P=.001), as well as recurrent urinary tract infections (adjusted odds ratio, 3.27; 95% confidence interval, 1.26-7.76; P=.013). There was no significant risk to develop a de novo overactive bladder (adjusted odds ratio, 1.48; 95% confidence interval, 0.56-3.91; P=.423) or urgency urinary incontinence (adjusted odds ratio, 1.47; 95% confidence interval, 0.71-3.06; P=.30). A concomitant pubovaginal sling was not protective against a recurrent diverticulum (adjusted odds ratio, 1.38; 95% confidence interval, 0.67-2.82; P=.374). Overall, the diverticulum recurrence rate was 10.1% and did not differ between the groups. CONCLUSION: This large retrospective cohort study demonstrated a greater resolution of stress urinary incontinence with the addition of a pubovaginal sling at the time of a urethral diverticulectomy. There was a considerable risk of postoperative urinary retention and recurrent urinary tract infections in the pubovaginal sling group.

Perioperative Outcomes for Combined Ventral Rectopexy With Sacrocolpopexy Compared to Perineal Rectopexy With Vaginal Apical Suspension.

OBJECTIVES: To describe and compare perioperative complications in women undergoing combined ventral rectopexy with sacrocolpopexy compared with perineal rectopexy with vaginal apical suspension. METHODS: Current Procedural Terminology codes were used to identify women in the National Surgical Quality Improvement Program database who underwent ventral rectopexy with sacrocolpopexy or perineal rectopexy with vaginal apical suspension from 2006 to 2015. Perioperative complication was defined as any of the following within 30 days of surgery: death, return to the operating room, transfusion, or vascular, wound, respiratory, infectious, or renal morbidity. Secondary outcomes included length of hospital stay, operative time, blood loss, readmission, and rate of urinary tract infections. Modified Poisson regression was used to estimate the adjusted relative risks of complication associated with surgical approach, abdominal versus perineal. RESULTS: Of the 273 women included, 240 (88%) underwent surgery with an abdominal approach, and 33 (12%) underwent surgery with a perineal approach. Perioperative complications occurred in 24 (9%) patients; 19 (8%) in the abdominal group and 5 (15%) in the perineal group. The age-adjusted risk of perioperative complications was not significantly different between those with a perineal approach compared with those with an abdominal approach (adjusted relative risk, 1.78; 95% confidence interval, 0.73-4.33). CONCLUSIONS: Patients in this database who underwent surgery with a vaginal/perineal approach were not more likely to have a postoperative complication after adjusting for age compared with those undergoing an abdominal approach. Larger studies are needed to determine a more precise estimate of the impact of surgical approach on rates of perioperative complications.

Mode of anesthesia and major perioperative outcomes associated with vaginal surgery.

INTRODUCTION AND HYPOTHESIS: The primary aim was to compare the incidence of major perioperative complications in women undergoing vaginal reconstructive surgery with general, regional, and monitored anesthesia care using a national database. The secondary aim was to compare length of hospital stay, 30-day readmission rates, urinary tract infections, and reoperation rates between anesthesia types. MATERIALS AND METHODS: The National Surgical Quality Improvement Program database was used to study women undergoing vaginal surgery for pelvic floor disorders from 2006 to 2015 via Current Procedural Terminology codes. Demographic and clinical variables were abstracted. The incidence of major perioperative complications was defined as the occurrence of any of the following within 30 days of surgery: death, surgical-site infection, pneumonia, venous thromboembolism, intensive care unit admission, stroke, transfusion, sepsis, and myocardial infarction. Regression analysis was used to estimate the relative risks (RR) associated with anesthesia type for each outcome. RESULTS: From the database, we gathered data on 37,426 women who underwent vaginal reconstructive surgery between 2006 and 2015; 87.2% (n = 32,623) underwent general, 6.9% (n = 2565) regional, and 5.9% (n = 2238) monitored anesthesia care. Major perioperative complications occurred in 560 women (1.5%). Relative to general anesthesia, the adjusted risk of major perioperative complications was not significantly different in those receiving monitored or regional anesthesia [monitored vs. general, adjusted RR 0.74, 95% confidence interval (CI) 0.45-1.20; regional vs. general, adjusted RR 1.23, 95% CI 0.92-1.65]. DISCUSSION: Major perioperative complications in vaginal reconstructive surgery were uncommon, and no differences were observed between monitored, regional, and general anesthesia outcomes.

Utility of Preoperative Laboratory Testing in Women Undergoing Suburethral Sling.

OBJECTIVE: The aim of the study was to examine current patterns and factors associated with preoperative testing in patients undergoing midurethral sling and to compare 30-day outcomes in subjects. METHODS: This retrospective cohort study was performed using the National Surgery Quality Improvement Program database from 2005 to 2014. All women undergoing midurethral slings were identified by Current Procedural Terminology code. Clinical variables were abstracted and the incidence of preoperative serum labs was determined. Multivariable logistic regression was used to estimate associations between clinical factors and collection of preoperative serum labs and between 30-day outcomes and collection of labs. RESULTS: A total of 12,368 women underwent midurethral sling in the National Surgery Quality Improvement Program database during the study period. Preoperative serum testing within 30 days before surgery was observed in 9172 (74.2%) women. Age, American Society of Anesthesiologists class, diabetes, and hypertension were strongly associated with preoperative testing when modeling together in multivariable regression. Of the 543 women who had any complication, 410 (75.5%) received preoperative testing. Urinary tract infection was the most frequent complication (66.1%). Age, American Society of Anesthesiologists class, body mass index, and presence of any comorbidity were associated with the presence of any complication at 30 days. Adjusting for these factors, the odds of complications were not significantly different between those who did and did not have preoperative testing (adjusted odds ratio = 0.98, 95% confidence interval = 0.78-1.24). CONCLUSIONS: Most women who underwent midurethral sling procedures had preoperative testing. Major postoperative complications were uncommon, and there was no substantial difference in outcomes between women who underwent preoperative testing and those who did not. In the future, surgeons may consider eliminating preoperative testing in low-risk patients.