Temporal Changes in Depressive Symptoms Among Goodville Farm Game Players: A 6-Week Observational Study.

Aim of the Study: The primary objective was to evaluate the potential impact of the Goodville farm game on depressive symptoms. Methods: The Goodville game, characterized by its unique farming features, incorporates elements of emotional well-being and various mental health assessment tools, enabling players to monitor and improve their emotional state. Using self-reported Patient Health Questionnaire-8 (PHQ-8) data from 1717 US and UK players, changes were monitored weekly over a 6-week period. The study focused on the game's ability to integrate emotional well-being elements and various mental health assessments to facilitate self-monitoring and improvement of players' emotional states. Results: There was a significant overall time effect (F = 154.498, df = 1711, P < 0.001), indicating a moderate-to-large effect size, with progressive decreases in PHQ-8 scores throughout the period. About 60% of players reported reduced depressive symptom severity, with around 35% experiencing complete symptom relief. More significant improvements were observed in players with higher initial severity. No correlations were found between symptom changes and demographic data or the number of active playing days. Conclusion: Goodville demonstrates potential as a digital mental health intervention in reducing depressive symptoms through its specific characteristics designed to improve emotional well-being. The study emphasizes the need to consider baseline severity and highlights the therapeutic promise of authentic farming game features. Despite the absence of a control group, the findings contribute meaningful insights into digital interventions for mental health care and set a direction for future studies to validate and expand upon these results.

A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair.

BACKGROUND: The choice of midurethral sling type may impact efficacy and complications in women undergoing transvaginal native tissue repair of pelvic organ prolapse. OBJECTIVE: The primary aim was to determine if the single-incision sling is noninferior to retropubic sling for the management of stress urinary incontinence among patients undergoing reconstructive or obliterative native tissue vaginal repair. The secondary aims were to compare adverse events and surgeon ease of use with sling assignment. STUDY DESIGN: A multicenter, noninferiority, randomized trial of women with ≥ stage II pelvic organ prolapse and objectively confirmed stress urinary incontinence undergoing reconstructive or obliterative vaginal repair was performed. Women were randomized to concomitant single-incision (Altis sling, Coloplast Minneapolis, MN) with suprapubic sham incisions or retropubic slings. The primary dichotomous outcome was abnormal lower urinary tract function within 12 months postsurgery, defined as bothersome stress urinary incontinence symptoms (>1 Pelvic Floor Distress Inventory question no. 17); retreatment for stress urinary incontinence or treatment for urinary retention. Secondary outcomes were adverse events, Patient Global Impression of Improvement of bladder function, and surgeon ease of use (1, worst; 10, best). All subjects completed validated questionnaires and underwent a Pelvic Organ Prolapse Quantification, cough stress test, and postvoid residual preoperatively, at 6 weeks and 12 months postoperatively. Assuming a subjective cure rate for retropubic of 82%, 80% power, and 1-sided 5% significance level, we estimated that 127 patients in each arm were needed to declare noninferiority of the single-incision sling if the upper bound of the 95% confidence interval for the between-group difference per protocol in abnormal bladder function was <12%. Assuming a 10% loss to follow-up, the total enrollment goal was 280. RESULTS: Between December 2018 and January 2023, 280 subjects were enrolled across 7 sites, and 255 were randomized: 126 were for single-incision, and 129 were for retropubic sling. There were no preoperative or operative characteristic differences between groups. Overall, 81% had reconstructive, and 19% had obliterative native tissue repairs. The primary outcome, abnormal lower urinary tract function at 12 months, occurred in 29 (25%) of single-incision vs 24 (20%) of the retropubic sling group (risk difference, 0.04472 [95% confidence interval, -0.03 to 0.1133]; P=.001 for noninferiority). Bothersome stress urinary incontinence occurred in 20% vs 17% (P=.27) and was retreated in 4% vs 2% (P=.44) of single-incision vs retropubic groups, respectively. Adverse events were reported in 24 (16%) of single-incision vs 14 (9%) of the retropubic group (95% confidence interval, 0.95-3.29; P=.70) and included de novo or worsening urgency incontinence symptoms, urinary tract infection, mesh exposure, need for prolonged catheter drainage, and de novo pain, without differences between groups. Patient Global Impression of Improvement (very satisfied and satisfied) was 71% vs 67% (P=.43), and median surgeon ease of sling use was 8 (7-10) vs 9 (8-10), P=.03 in single-incision vs retropubic, respectively. CONCLUSION: For women undergoing vaginal repair, single-incision was noninferior to retropubic sling for stress urinary incontinence symptoms, and complications, including treatment for urinary retention, did not differ.

A prospective pilot study to assess for histologic changes on vulvar biopsies in postmenopausal women with lichen sclerosus treated with fractionated CO2 laser therapy.

OBJECTIVES: To investigate the histologic characteristics of vulvar tissues before and after completion of fractionated carbon dioxide (CO2 ) laser therapy (FxCO2) for vulvar lichen sclerosus (LS). The secondary objective was to assess subjective improvement in symptoms via the Skindex-16 questionnaire. METHODS: This prospective single-arm study was conducted from April 2021 to August 2022 at one academic medical center. Ten postmenopausal women with biopsy-proven LS planning FxCO2 laser treatment were enrolled. Exclusion criteria included prior transvaginal mesh for prolapse, topical corticosteroid use within 8 weeks, prior pelvic radiation, malignancy, active genital infection, or pregnancy. The vulvovaginal SmartXide2-V2-LR laser system fractionated CO2 laser (DEKA) was utilized to treat visually affected areas of vulvar and perianal LS with a single pass. Subjects underwent three treatments 4-6 weeks apart. Subjects completed the Skindex-16 questionnaire and had vulvar biopsy at baseline and at 4 weeks after completion of fractionated CO2 laser therapy. Blinded histologic slides were scored by one dermatopathologist (Michael A. Cardis) rating from 1 to 5 the degree of dermal sclerosis, inflammation, and epidermal atrophy. Change scores were calculated as the difference between pre- and post-treatment scores for each subject. RESULTS: The 10 subjects enrolled had a mean age of 61 and most were white, privately insured, and had a college/graduate-level education. Post-fractionated CO2 laser treatment vulvar biopsies showed significant improvement in sclerosis and epidermal atrophy compared with pretreatment baseline biopsy specimens (p < 0.05) with no statistically significant change found in inflammation score. Skindex-16 and FSFI scores showed a trend towards improvement (p > 0.05 for both). A statistically significant correlation was found between change in sclerosis and Skindex-16 symptoms scores with an average change of 21.4 units in Skindex-16 symptoms score for every one-point change in histologic sclerosis score (p = 0.03). CONCLUSIONS: In postmenopausal women with vulvar LS undergoing fractionated CO2 laser, symptomatic improvements correlated with histologic change in degree of sclerosis on vulvar biopsy. These results demonstrate FxCO2 laser therapy as a promising option for the treatment of LS and suggest that further studies should assess degree of sclerosis on histopathology.

Assessing the Impact of Vaginal Hysterectomy with Vaginal Mesh Attachment on Outcomes and Complications during Minimally Invasive Sacrocolpopexy.

STUDY OBJECTIVE: To compare mesh complications and failure rates after 1 year in laparoscopic minimally invasive sacrocolpopexy (MISC) with ultralightweight mesh attached vaginally during total vaginal hysterectomy (TVH), laparoscopically if posthysterectomy (PH), or laparoscopically during supracervical hysterectomy. DESIGN: Single-center retrospective cohort study. SETTING: Tertiary referral center. PATIENTS: Women with symptomatic pelvic organ prolapse who elected for MISC. INTERVENTIONS: Laparoscopic MISC with ultralightweight mesh attached vaginally during TVH, laparoscopically if PH, or laparoscopically during supracervical hysterectomy. Composite failure was defined as recurrent prolapse symptoms, prolapse past the hymen, or retreatment for prolapse. MEASUREMENTS AND MAIN RESULTS: Between 2010 and 2017, 650 patients met the inclusion criteria with 278 PH, 82 supracervical hysterectomy, and 290 vaginal hysterectomy patients. Median follow-up was similar for all groups (382 days vs 379 vs 345; p = .31). The majority in all groups were white (66.6%), nonsmokers (74.8%), postmenopausal (82.5%), and did not use estrogen (70.3%). Mesh complications did not differ among groups (1.6% PH, 2.5% supracervical hysterectomy, 2.2% vaginal hysterectomy; p >.99). There was no difference in anatomic failure (5% PH, 1.2% supracervical hysterectomy, 2.1% vaginal hysterectomy; p = .07), reoperation for prolapse (1.4% vs 1.2% vs 0.7%; p = .57), or composite failure (9.0% vs 3.7% vs 4.8%; p = .07). CONCLUSIONS: TVH with vaginal mesh attachment of ultralightweight mesh had similar adverse events, mesh exposure rates, and failure rates to those of laparoscopic PH sacrocolpopexy or supracervical hysterectomy with laparoscopic mesh attachment.

Mesh Exposure Following Vaginal Versus Laparoscopic Hysterectomy at the Time of Sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: To compare vaginal mesh exposure rates, adverse events and composite failure within 1 year postoperatively in patients who undergo vaginal hysterectomy with vaginal mesh attachment (TVH) versus laparoscopic hysterectomy with abdominal mesh attachment (TLH) for minimally invasive sacrocolpopexy. METHODS: This multicenter retrospective cohort study is a secondary analysis of data collected retrospectively at one institution and the multicenter randomized control PACT trial. Women were excluded for no follow-up between 9 months and 2 years postoperatively or undergoing concurrent non-urogynecologic procedures. RESULTS: Between 2010 and 2019, 182 patients underwent TLH and 132 TVH. There were 15 (4.8%) vaginal mesh exposures: 12 (6.6%) in the TLH and 3 (2.3%) in the TVH group (p = 0.133) with zero mesh erosions. Logistic regression analysis for mesh exposure in the TLH vs. TVH groups controlling for BMI, posterior repair and surgeon training also showed no significant difference (OR 4.8, 95% CI 0.94, 24.8, p = 0.059). The overall intraoperative complication rate was low (19/314, 6.1%) with a higher rate of bladder injury in the TLH group (4.4% vs. 0.8%, p = 0.049). The TLH group had a higher rate of UTI (8.2% vs. 2.3%, p = 0.027) and clean intermittent catheterization (11% vs. 3%, p = 0.009). At 1-year follow-up, there was no difference in composite failure (6%), bulge symptoms (5%) or retreatment (1%) between groups. CONCLUSIONS: At 1 year, there is no significant difference in vaginal mesh exposure rates between vaginal hysterectomy with vaginal mesh attachment and laparoscopic hysterectomy with abdominal mesh attachment. Both groups have equal efficacy with low rates of complications.

Minimally Invasive Surgery Survey: A Survey of Surgical Team Members' Perceptions for Successful Minimally Invasive Surgery.

STUDY OBJECTIVE: To develop a valid and reliable survey to measure surgical team members' perceptions regarding their institution's requirements for successful minimally invasive surgery (MIS). DESIGN: Questionnaire development and validation study (Canadian Task Force classification II-2). SETTING: Three hospital types: rural, urban/academic, and community/academic. PARTICIPANTS: Minimally invasive staff (team members). INTERVENTION: Development and validation of a minimally invasive surgery survey (MISS). MEASUREMENT AND MAIN RESULTS: Using the Safety Attitudes questionnaire as a guide, we developed questions assessing study participants' attitudes regarding the requirements for successful MIS. The questions were closed-ended and responses based on a 5-point Likert scale. The large pool of questions was then given to 4 focus groups made up of 3 to 6 individuals. Each focus group consisted of individuals from a specific profession (e.g., surgeons, anesthesiologists, nurses, and surgical technicians). Questions were revised based on focus group recommendations, resulting in a final 52-question set. The question set was then distributed to MIS team members. Individuals were included if they had participated in >10 MIS cases and worked in the MIS setting in the past 3 months. Participants in the trial population were asked to repeat the questionnaire 4 weeks later to evaluate internal consistency. Participants' demographics, including age, gender, specialty, profession, and years of experience, were captured in the questionnaire. Factor analysis with varimax rotation was performed to determine domains (questions evaluating similar themes). For internal consistency and reliability, domains were tested using interitem correlations and Cronbach's α. Cronbach's α > .6 was considered internally consistent. Kendall's correlation coefficient τ closer to 1 and with p < .05 was considered significant for the test-retest reliability. Two hundred fifty participants answered the initial question set. Of those, 53 were eliminated because they did not meet inclusion criteria or failed to answer all questions, leaving 197 participants. Most participants were women (68% vs 32%), and 42% were between the ages 30 and 39 years. Factor analysis identified 6 domains: collaboration, error reporting, job proficiency/efficiency, problem-solving, job satisfaction, and situational awareness. Interitem correlations testing for redundancy for each domain ranged from .2 to .7, suggesting similar themed questions while avoiding redundancy. Cronbach's α, testing internal consistency, was .87. Sixty-two participants from the original cohort repeated the question set at 4 weeks. Forty-three were analyzed for test-retest reliability after excluding those who did not meet inclusion criteria. The final questions showed high test-retest reliability (τ = .3-.7, p < .05). The final questionnaire was made up of 29 questions from the original 52 question set. CONCLUSION: The MISS is a reliable and valid tool that can be used to measure how surgical team members conceptualize the requirements for successful MIS. The MISS revealed that participants identified 6 important domains of a successful workenvironment: collaboration, error reporting, job proficiency/efficiency, problem-solving, job satisfaction, and situational awareness. The questionnaire can be used to understand and align various surgical team members' goals and expectations and may help improve quality of care in the MIS setting.

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.

Effect of a New Risk Calculator on Patient Satisfaction With the Decision for Concomitant Midurethral Sling During Prolapse Surgery: A Randomized Controlled Trial.

OBJECTIVE: To determine whether use of a new personalized risk calculator increases patient satisfaction with the decision whether or not to have a prophylactic midurethral sling (MUS) during pelvic organ prolapse (POP) surgery. METHODS: We performed a randomized controlled trial involving English-speaking women without symptoms of stress urinary incontinence (SUI) with ≥ stage 2 POP who planned to undergo POP surgery with 1 of 4 fellowship-trained urogynecologists at a single academic center. Women with a history of prior POP or incontinence surgery, or who were pregnant, or unable to complete study forms were excluded. Participants were randomly assigned to standard preoperative counseling or preoperative counseling with the use of a validated, online risk calculator for de novo SUI after POP surgery. The primary outcome was patient satisfaction with the decision for prophylactic MUS placement during POP surgery at 3 months postoperative assessed using the Satisfaction with Decision Scale for Pelvic Floor Disorders. RESULTS: Sixty-three women were approached for participation. Forty-two agreed to participate, 41 underwent randomization, and 33 had POP surgery and completed 3-month follow-up. Of these 33, 17 were randomized to the risk calculator and 16 to standard counseling. The mean age was 61.2 ± 9.1 years, and 41% (14/33) had a prophylactic MUS. At 3 months postoperative, there was no difference in Satisfaction with Decision Scale for Pelvic Floor Disorders scores between groups (4.67 ± 0.46 [intervention] vs 4.78 ± 0.34 [control]; P = 0.61). CONCLUSIONS: Use of the de novo SUI risk calculator did not increase patient satisfaction with the decision regarding MUS placement during POP surgery.

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.

Pelvic Organ Prolapse---Vaginal and Laparoscopic Mesh: The Evidence.

This report summarizes the current literature on abdominal, laparoscopic, and transvaginal mesh for the treatment of pelvic organ prolapse. This article reviews objective and subjective cure rates as well as complications associated with synthetic mesh use for pelvic organ prolapse repair. The focus is on the latest literature that provides evidence for when synthetic mesh use is most appropriate. The use of mesh for the repair of urinary incontinence is not reviewed in this article.

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.

Significance of cystoscopic bladder trabeculations in women undergoing midurethral sling.

INTRODUCTION: To determine the significance of bladder trabeculations seen on preoperative cystoscopy prior to midurethral sling surgery with respect to lower urinary tract symptoms and sling outcomes. MATERIALS AND METHODS: This retrospective study included women with preoperative cystoscopy who underwent midurethral slings for urinary incontinence from 2006-2009. Cystoscopic findings of bladder trabeculations, as well as pre and postoperative urinary symptoms were recorded. Patients with and without bladder trabeculations were compared with respect to baseline characteristics, lower urinary tract symptoms, and sling outcomes. RESULTS: Of the 241 women included in the study, 14.9% had trabeculations on preoperative cystoscopy. At baseline, women with trabeculations were more likely to be older (64.8 years versus 57.8 years, p < 0.01), and have lower mean maximum cystometric capacity (341 mL +/- 136 versus 436 mL +/- 148, p < 0.01), compared to those without trabeculations. More women with trabeculations had mixed incontinence (p < 0.01) and less pure stress incontinence (p < 0.01) preoperatively. There was no difference between women with and without trabeculations with respect to pre and postoperative symptoms of urgency, frequency, and nocturia. Women with preoperative trabeculations were more likely to have preoperative treatment with anticholinergics (p = 0.02) and had a three times higher risk of postoperative sling failure (HR 2.95 [CI 1.11-7.85], p = 0.03). CONCLUSIONS: Preoperative cystoscopic bladder trabeculations are associated with significantly higher rate of midurethral sling failure. Trabeculations were not associated with pre or postoperative lower urinary tract symptoms.

Foley catheter guide use during midurethral slings: does it make a difference?

INTRODUCTION: Our objective was to evaluate whether foley catheter guide use decreased the risk of cystotomy and urethrotomy during retropubic midurethral sling placement. MATERIALS AND METHODS: This retrospective cohort study included all women undergoing retropubic synthetic midurethral sling placement at a single academic institution between January 2011 and September 2012. Patients were divided into groups based on whether or not the foley catheter guide was used during surgery. The primary outcome was the incidence of cystotomy. RESULTS: A total of 310 patients underwent retropubic midurethral sling placement. The foley catheter guide was used in 76/310 cases (24.5%). The mean age was 57 ± 11 and mean body mass index was 28 ± 7. More patients in the no-guide group had preoperative urgency (70% versus 58%, p = 0.049), anterior prolapse (95% versus 78%, p < 0.0001), and concomitant prolapse surgery (65% versus 51%, p = 0.03). There was no difference in preoperative urgency urinary incontinence, medical comorbidities, previous surgical history, intraoperative time, blood loss, or postoperative voiding dysfunction rates between groups. Fourteen of the 310 patients (4.5%) had cystotomies: 1/76 (1.3%) in the foley catheter guide group and 13/234 (5.6%) in the no-guide group (p = 0.12). No patients had urethrotomies. On multiple logistic regression, there was no difference in the odds of cystotomy between groups after adjusting for previous prolapse and anti-incontinence surgery, concomitant prolapse repair, level of first assistant, and retropubic local anesthesia use (AOR = 0.2 [95% CI 0.02-1.7]). CONCLUSIONS: Foley catheter guide use did not decrease the risk of intraoperative lower urinary tract injury during retropubic midurethral sling placement. Larger prospective studies are needed to confirm this finding.

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.

Hysterectomy and urinary incontinence in postmenopausal women.

INTRODUCTION AND HYPOTHESIS: To evaluate an association between hysterectomy and urinary incontinence (UI) in postmenopausal women. METHODS: Women (aged 50-79) with uteri (N = 53,569) and without uteri (N = 38,524) who enrolled in the Women's Health Initiative (WHI) Observational Study between 1993 and 1996 were included in this secondary analysis. Baseline (BL) and 3-year demographic, health/physical forms and personal habit questionnaires were used. Statistical analyses included univariate and logistic regression methods. RESULTS: The baseline UI rate was 66.5 %, with 27.3 % of participants having stress urinary incontinence (SUI), 23 % having urge UI (UUI), and 12.4 % having mixed UI (MUI). 41.8 % of women had undergone hysterectomy, with 88.1 % having had the procedure before age 54. Controlling for health/physical variables, hysterectomy was associated with UI at BL (OR 1.25, 95 % CI 1.19, 1.32) and over the 3-year study period (OR 1.23, 95 % CI 1.11, 1.36). Excluding women with UI at BL, a higher incidence of UUI and SUI episodes was found in hysterectomy at year 3. Among women who had undergone hysterectomy, those with bilateral oophorectomy (BSO) did not have increased odds of developing UI at BL or over the 3-year study period. Hormone use was not associated with a change in UI incidence (estrogen + progesterone, p = 0.17; unopposed estrogen, p = 0.41). CONCLUSIONS: Risk of UI is increased in postmenopausal women who had undergone hysterectomy compared with women with uteri.

Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial.

OBJECTIVE: To present the 3-year outcomes of a double-blind, multicenter, randomized trial comparing vaginal prolapse repair with and without mesh. METHODS: This was a planned final analysis of women with Pelvic Organ Prolapse Quantification (POP-Q) stage 2-4 prolapse randomized to traditional vaginal prolapse surgery without mesh and vaginal colpopexy repair with mesh. We evaluated anatomic, symptomatic, and combined cure rates for those with at least 3-year validated quality-of-life questionnaires and 2- or 3-year postoperative blinded POP-Q examination. Participants undergoing reoperation for recurrent prolapse were removed for anatomic and subjective outcomes analysis and considered failures for combined outcomes analysis. RESULTS: Sixty-five women were enrolled (33 mesh, 32 no mesh) before the study was prematurely halted as a result of a 15.6% mesh exposure rate. At 3 years, 51 of 65 (78%) had quality-of-life questionnaires (25 mesh, 26 no mesh) and 41 (63%) had examinations. Three participants died, three required reoperation for recurrent prolapse (all in mesh group), and eight were lost to follow-up. No differences were observed between groups at 3 years for prolapse stage or individual prolapse points. Stage improved for each group (90% and 86%) from baseline to 3 years (P<.01). Symptomatic improvement was observed with no differences in scores between groups. Cure rates did not differ between groups using a variety of definitions, and anatomic cure was lowest for the anterior compartment. CONCLUSION: There was no difference in 3-year cure rates when comparing patients undergoing traditional vaginal prolapse surgery without mesh with those undergoing vaginal colpopexy repair with mesh. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540. LEVEL OF EVIDENCE: : I.

Surgical repair of rectovaginal fistulas in patients with Crohn's disease.

OBJECTIVES: To report surgical outcomes of patients who underwent rectovaginal fistula (RVF) repair with a history of Crohn's disease utilizing several reconstructive techniques. STUDY DESIGN: Retrospective case series of women (n=6) with Crohn's disease surgically treated with either vaginal or rectal advancement flaps. Demographic information and data specific to Crohn's disease at the time of surgery were collected. In addition, operative reports and postoperative follow-up visits were reviewed. RESULTS: During the study period, six women with the diagnosis of Crohn's disease and RVF underwent surgical management. Five patients had a vaginal advancement flap (VAF) by Female Pelvic Medicine and Reconstructive Surgery and one patient was treated by the rectal advancement flap by Colorectal Surgery. The failure rate in our study population was 33% (2/6). Of note, two of the patients who had a successful VAF had a previous failure after RAF. In addition, four patients who had a repair via the transvaginal approach had a concomitant pedicled flap procedure (i.e. Martius or gracilis flap). The average follow-up for all our patients was 5 months (+/- 6.5 months). No patients failed if they received a VAF with a concomitant flap procedure. CONCLUSIONS: This case series illustrates several techniques utilized for the repair of RVF in patients with Crohn's disease. The use of a bulbocavernosus flap during the primary repair of RVF in this patient population may be considered to bolster the rectovaginal septum.

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.

Blinded assessment of operative performance after fundamentals of laparoscopic surgery in gynecology training.

STUDY OBJECTIVE: To determine the pass rate for the Fundamentals of Laparoscopic Surgery (FLS) examination among senior gynecology residents and fellows and to find whether there is an association between FLS scores and previous laparoscopic experience as well as laparoscopic intraoperative (OR) skills assessment. DESIGN: Prospective cohort study (Canadian Task Force classification II-2). SETTING: Three gynecology residency training programs. PARTICIPANTS: Third- and fourth-year gynecology residents and urogynecology fellows. INTERVENTIONS: All participants participated in the FLS curriculum, written and manual skills examination, and completed a survey reporting baseline characteristics and opinions. Fourth-year residents and fellows underwent unblinded and blinded pre- and post-FLS OR assessments. Objective OR assessments of fourth-year residents after FLS were compared with those of fourth-year resident controls who were not FLS trained. MEASUREMENTS AND MAIN RESULTS: Twenty-nine participants were included. The overall pass rate was 76%. The pass rate for third- and fourth-year residents and fellows were 62%, 85%, and 100%, respectively. A trend toward improvement in OR assessments was observed for fourth-year residents and fellows for pre-FLS curriculum compared with post-FLS testing, and FLS-trained fourth-year residents compared with fourth-year resident controls; however, this did not reach statistical significance. Self-report of laparoscopic case load experience of >20 cases was the only baseline factor significantly associated with passing the FLS examination (p = .03). CONCLUSION: The FLS pass rate for senior residents and fellows was 76%, with higher pass rates associated with increasing levels of training and laparoscopic case experience.