Telehealth in a Pelvic Floor Physical Therapy Clinic: A Retrospective Cohort Study.

IMPORTANCE: Telehealth offers advantages to patients with pelvic floor disorders because they face unique barriers to care; however, attendance of telehealth appointments is unknown. OBJECTIVE: The objective of this study was to examine the attendance of telehealth appointments in urogynecology patients receiving pelvic floor physical therapy as compared with in-person visits before and during the COVID-19 pandemic. STUDY DESIGN: We retrospectively collected electronic medical record data from patients engaging in pelvic floor physical therapy from 2019, and pre- and post-COVID-19 in 2020. Information included appointment type, attendance, age, primary diagnoses, insurance status, and zip code. Cohort differences were examined using the χ2 test and analyses of variance. RESULTS: Our sample included 359 individuals scheduled for in-person visits in 2019, 57 for telehealth visits in 2020, and 283 for in-person visits in 2020. Patients scheduled for telehealth appointments were younger (39 ± 13 years) than patients in 2019 (45 ± 14 years) or 2020 (42 ± 14 years) in-person cohorts (χ2 (2, 696) = 6.8, P < 0.001). Patients attended telehealth appointments at higher rates (73.7%) than in-person visits in 2019 (56.8%) and 2020 (45.6%; χ2 (2, 699) = 26.2, P < 0.001). Attendance did not differ across primary diagnoses. Proximity based on zip code was not associated with attendance. CONCLUSIONS: Pelvic floor physical therapy attendance rates were highest for patients with telehealth visits as compared with in-person visits. Our findings encourage health care providers to continue or begin to offer telehealth visits for pelvic floor physical therapy for the urogynecology patient population.

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.

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

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

Engaging Women in Pelvic Floor Disorders Research Using the Internet.

OBJECTIVES: The objective of this study were (1) to assess the feasibility of using online platforms as recruitment tools for pelvic floor disorder studies and (2) to compare the prevalence of symptoms of incontinence and care-seeking behavior by online platform to previously published prevalence estimates. METHODS: We conducted a cross-sectional study among women to assess the prevalence of incontinence symptoms, level of bother, and care-seeking behavior. Participants were recruited through Facebook ads, ResearchMatch, or Reddit. The effectiveness of Facebook ads was assessed using the click through rate and an overall completion rate (number of completes over number of times an ad was shown). A nontargeted ad was posted to a Reddit thread in which research opportunities are advertised. For ResearchMatch, investigators sent a recruitment email. Effectiveness of this method was assessed by observing how many women completed the survey compared with the number of women who received it. RESULTS: Among the 7361 women who initiated the questionnaire, 6650 (90%) completed it. A majority of participants were recruited through ResearchMatch. Online platforms were successful in recruiting women across a wide age range (ages, 18-93 years). The overall prevalence of incontinence was 46.1% with women 45 years and older having the highest prevalence (64.6%). Common reasons for not seeking care included "not bothersome enough," "other health problems," and "being unsure about treatment." CONCLUSIONS: Internet-based recruitment was found to be feasible. The prevalence of incontinence was higher than has been reported in other population-based samples. Significant barriers to care exist, and further studies should focus on educational strategies.

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.

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.

The incidence of transfusion and associated risk factors in pelvic reconstructive surgery.

BACKGROUND: Almost 400,000 female pelvic reconstructive operations were performed in 2010 for urinary incontinence and pelvic organ prolapse in the United States, and it is likely that this will continue to increase each year. There is a lack of population-based data evaluating the risk of blood transfusion after urogynecologic procedures. OBJECTIVE: We sought to assess the incidence of blood transfusion related to pelvic reconstructive surgery in a large national surgical quality database and to identify transfusion-associated risk factors. STUDY DESIGN: This retrospective cohort study was performed using the National Surgical Quality Improvement Program database from the years 2010 through 2014. All women undergoing surgery for pelvic floor disorders were identified by Current Procedural Terminology code. Demographic and clinical variables were abstracted. The incidence of blood transfusion was determined. A multivariate logistic regression analysis was performed to identify clinical factors independently associated with blood transfusion. RESULTS: A total of 54,387 women underwent pelvic reconstructive surgery from 2010 through 2014 in the National Surgical Quality Improvement Program database. Of these subjects, 686 (1.26%) received a blood transfusion. The median age was 57 (range 28-89) years. Of the population, 0.81% was underweight (body mass index <18.5), 27.0% was normal weight (body mass index 18.5-24.9), 35.6% was overweight (body mass index 25-29.9), and 36.7% was obese (body mass index ≥30). The majority of subjects in the study cohort were Caucasian (91.4%) followed by African Americans (4.6%); the remainder included Asian, American Indian/Alaska Native, and Native Hawaiian/Pacific Islander. Hispanic ethnicity was reported in 9.3% of the population. American Society of Anesthesiologists class 1 and 2 represented a majority of the sample (76.5%). Concomitant hysterectomy was performed in 20,735 (38.1%) of the population. In the multivariate analysis, preoperative hematocrit <30% (odds ratio, 13.68; 95% confidence interval, 10.65-17.59), history of coagulopathy (odds ratio, 3.74; 95% confidence interval, 2.50-5.60), and concomitant hysterectomy (odds ratio, 1.77; 95% confidence interval, 1.49-2.12) were factors independently associated with receiving blood transfusion (all P < .05). When compared to American Society of Anesthesiologists class 1, patients who were class 3 (odds ratio, 2.82, P < .01; 95% confidence interval, 2.02-3.93) or class 4 (odds ratio, 6.56, P < .01; 95% confidence interval, 3.65-11.78) were more likely to require a transfusion. When compared to Caucasians, African Americans (odds ratio, 1.73, P < .01; 95% confidence interval, 1.27-2.36) and Hispanics (odds ratio, 1.92, P < .01; 95% confidence interval, 1.54-2.40) were more likely to require a transfusion. In this cohort, overweight (odds ratio, 0.75; 95% confidence interval, 0.62-0.93) and obese (odds ratio, 0.61; 95% confidence interval, 0.49-0.75) subjects were less likely to receive a transfusion. When compared to a vaginal approach, patients who had a minimally invasive approach (odds ratio, 0.63; 95% confidence interval, 0.49-0.83) were less likely to receive a transfusion, while those with an open approach were more likely to receive a transfusion (odds ratio, 5.43; 95% confidence interval, 4.49-6.56). Age was not a risk factor for transfusion. CONCLUSION: Transfusion after pelvic reconstructive surgery is uncommon. The variables associated with transfusion are preoperative hematocrit <30%, American Society of Anesthesiologists class, bleeding disorders, nonwhite race, Hispanic ethnicity, and concomitant hysterectomy. Recognition of these factors can help guide preoperative counseling regarding transfusion risk after pelvic reconstructive surgery and individualize preoperative preparation.

Thermodynamic characterization of RNA triloops.

Relatively few thermodynamic parameters are available for RNA triloops. Therefore, 24 stem-loop sequences containing naturally occurring triloops were optically melted, and the thermodynamic parameters ΔH°, ΔS°, ΔG°(37), and T(M) for each stem-loop were determined. These new experimental values, on average, are 0.5 kcal/mol different from the values predicted for these triloops using the model proposed by Mathews et al. [Mathews, D. H., Disney, M. D., Childs, J. L., Schroeder, S. J., Zuker, M., and Turner, D. H. (2004) Proc. Natl. Acad. Sci. U.S.A. 101, 7287-7292]. The data for the 24 triloops reported here were then combined with the data for five triloops that were published previously. A new model was derived to predict the free energy contribution of previously unmeasured triloops. The average absolute difference between the measured values and the values predicted using this proposed model is 0.3 kcal/mol. These new experimental data and updated predictive model allow for more accurate calculations of the free energy of RNA stem-loops containing triloops and, furthermore, should allow for improved prediction of secondary structure from sequence.