Risk Factors of Pelvic Floor Disorders Among Women in Rural Nepal: A Case-Control Study.

INTRODUCTION AND HYPOTHESIS: Risk factors for pelvic floor disorders (PFDs) are not well understood in lower resource settings. The objective of this study is to determine the risk factors associated with stress urinary incontinence (SUI), urge urinary incontinence (UUI), and pelvic organ prolapse (POP) among women of reproductive age in rural Nepal. METHODS: This is a case-control study nested within a community-based cross-sectional survey of parous women of reproductive age with PFDs in the Sarlahi District of Nepal. The presence of PFDs was confirmed by clinical assessment. Detailed sociodemographic information and histories were captured. RESULTS: We examined 406 women; the mean (SD, range) age was 32.7 (8.5, 16-49) years, mean BMI (SD) was 19.7 (3.3) kg/m2, and median (range) number of pregnancies was 4 (1-11). Two hundred and three women (50.0%) had either SUI or UUI, 85 (17.8%) had both SUI and UUI, and 71 (17.5%) had POP at or beyond the hymen. After controlling for other variables significant on bivariate analysis, age (adjusted odds ratio [aOR] 1.06 [95% CI 1.03-1.09]), illiteracy (aOR 2.24 [95% CI 1.04-4.80]), and presence of upper gastrointestinal issues (aOR 3.30, [95% CI 1.77-6.16]) were independently associated with SUI/UUI. Age (aOR 1.05 [95% CI 1.02-1.09]), bispinous diameter (aOR 2.88 ([95% CI 1.11-7.47]), and subpubic angle (aOR 2.78 [95% CI 1.55-5.03]) were independently associated with POP. CONCLUSION: Risk factors for PFDs in a homogenous community of parous women of reproductive age in rural Nepal are similar to those found in parous women in higher income countries.

Women's sexual activity and experiences following female genital fistula surgery.

BACKGROUND: Surgical repair has a transformative impact on the lives of women affected by female genital fistula; however, various physical, social, and economic challenges may persist postrepair and prevent complete reengagement in relationships and communities. Nuanced investigation of these experiences is needed to inform programming that aligns with women's reintegration needs. AIM: We investigated the sexual activity resumption, experiences, and concerns of women in Uganda during the year following genital fistula repair surgery. METHODS: Women were recruited from Mulago Hospital between December 2014 and June 2015. We collected data at baseline and 4 times postsurgery about sociodemographic characteristics and physical/psychosocial status; we also assessed sexual interest and satisfaction twice. We performed in-depth interviews with a subset of participants. We analyzed quantitative findings via univariate analyses, and qualitative findings were coded and analyzed thematically. OUTCOMES: We assessed sexual readiness, fears, and challenges following surgical repair of female genital fistula using quantitative and qualitative measures of sexual activity, pain with sex, sexual interest/disinterest, and sexual satisfaction/dissatisfaction. RESULTS: Among the 60 participants, 18% were sexually active at baseline, which decreased to 7% postsurgery and increased to 55% at 1 year after repair. Dyspareunia was reported by 27% at baseline and 10% at 1 year; few described leakage during sex or vaginal dryness. Qualitative findings showed wide variance of sexual experiences. Some reported sexual readiness quickly after surgery, and some were not ready after 1 year. For all, fears included fistula recurrence and unwanted pregnancy. CONCLUSION: These findings suggest that postrepair sexual experiences vary widely and intersect meaningfully with marital and social roles following fistula and repair. In addition to physical repair, ongoing psychosocial support is needed for comprehensive reintegration and the restoration of desired sexuality.

Prolapse and mesh reoperations following sacrocolpopexy: comparing supracervical hysterectomy, total hysterectomy, and no hysterectomy.

INTRODUCTION AND HYPOTHESIS: Sacrocolpopexy is effective for apical prolapse repair and is often performed with hysterectomy. It is unknown whether supracervical or total hysterectomy at time of sacrocolpopexy influences prolapse recurrence and mesh complications. The primary objective of this study is to compare reoperations for recurrent prolapse after sacrocolpopexy with either supracervical hysterectomy or total hysterectomy, or without concomitant hysterectomy. We also sought to compare these three groups for the incidence of mesh complications and describe cervical interventions following supracervical hysterectomy. METHODS: A retrospective cohort study of sacrocolpopexy was performed using the MarketScan® Research Database. Women > 18 years who underwent sacrocolpopexy between 2010 to 2014 were identified. Utilizing diagnostic and procedural codes, reoperations for prolapse and mesh complications were identified. Women with < 2 years of follow-up were excluded. RESULTS: From 2010 to 2014, 3463 women underwent sacrocolpopexy with at least 2 years of follow-up, 910 (26.3%) with supracervical hysterectomy, 1243 (35.9%) with total hysterectomy, and 1310 (37.8%) without hysterectomy. Reoperations for prolapse were similar after supracervical hysterectomy (1.5%), after total hysterectomy (1.1%, p = 0.40), and without hysterectomy (1.5%, p = 0.98). Mesh complications after sacrocolpopexy were similar after supracervical hysterectomy (1.8%), after total hysterectomy (1.5%, p = 0.68), and without hysterectomy (2.8%, p = 0.11). Following supracervical hysterectomy, 0.9% underwent cervical procedures. CONCLUSIONS: When comparing supracervical and total hysterectomy at time of sacrocolpopexy, there were no significant differences in reoperations for recurrent prolapse, reoperations for mesh complications, or mesh complication diagnoses. This study shows that surgeons can be reassured on performing hysterectomy with sacrocolpopexy.

Pelvic floor disorder assessment of knowledge and symptoms: an educational intervention for Spanish-speaking women (PAKS study).

INTRODUCTION AND HYPOTHESIS: Educational interventions have been effective in improving postpartum knowledge, performance of pelvic floor exercises, and bowel-specific quality-of-life. Our primary objective was to determine if a video-based educational intervention on pelvic floor disorders (PFDs) would increase Spanish-speaking women's knowledge of PFDs, and secondarily to assess if it would decrease pelvic floor symptoms. We hypothesized that Spanish-speaking women would improve their pelvic floor knowledge and symptoms post-intervention. METHODS: Inclusion criteria included women age 18 years and older and self-reported as a predominantly Spanish-speaker or equally bilingual English- and Spanish-speaker. Changes in knowledge were assessed with the Prolapse and Incontinence Knowledge Questionnaire (PIKQ). Changes in symptoms were assessed with the Pelvic Floor Distress Inventory-20 (PFDI-20). Linear regression assessed for independent effects. RESULTS: One hundred and fourteen women were enrolled and 112 completed the pre- and post-intervention PIKQ. Mean (standard deviation [SD]) age was 50 (14) years. Immediate post-intervention scores showed significant improvement in knowledge. Total PIKQ score improved by 5.1 (4.7) points (p < 0.001). POP subscore improved by 2.7 (2.7) points (p<0.001) and UI subscore improved by 2.3 (2.5) points (p < 0.001). Improvement in knowledge continued after four weeks (p < 0.001). PFDI-20 prolapse (p=0.02), colorectal-anal (p < 0.001) and urinary (p = 0.01) scores significantly improved only for the most symptomatic women at baseline. Using linear regression, total PIKQ (p = 0.03) and total PFDI-20 scores (p = 0.04) were associated with predominantly Spanish-speakers versus fully bilingual. CONCLUSION: Findings support the efficacy of a video-based educational intervention to improve knowledge of PFDs in Spanish-speaking women. The most symptomatic women benefitted from this intervention.

Effect of pre-operative warm-up on trainee intraoperative performance during robot-assisted hysterectomy: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The objective was to study the effect of immediate pre-operative warm-up using virtual reality simulation on intraoperative robot-assisted laparoscopic hysterectomy (RALH) performance by gynecology trainees (residents and fellows). METHODS: We randomized the first, non-emergent RALH of the day that involved trainees warming up or not warming up. For cases assigned to warm-up, trainees performed a set of exercises on the da Vinci Skills Simulator immediately before the procedure. The supervising attending surgeon, who was not informed whether or not the trainee was assigned to warm-up, assessed the trainee's performance using the Objective Structured Assessment for Technical Skill (OSATS) and the Global Evaluative Assessment of Robotic Skills (GEARS) immediately after each surgery. RESULTS: We randomized 66 cases and analyzed 58 cases (30 warm-up, 28 no warm-up), which involved 21 trainees. Attending surgeons rated trainees similarly irrespective of warm-up randomization with mean (SD) OSATS composite scores of 22.6 (4.3; warm-up) vs 21.8 (3.4; no warm-up) and mean GEARS composite scores of 19.2 (3.8; warm-up) vs 18.8 (3.1; no warm-up). The difference in composite scores between warm-up and no warm-up was 0.34 (95% CI: -1.44, 2.13), and 0.34 (95% CI: -1.22, 1.90) for OSATS and GEARS respectively. Also, we did not observe any significant differences in each of the component/subscale scores within OSATS and GEARS between cases assigned to warm-up and no warm-up. CONCLUSION: Performing a brief virtual reality-based warm-up before RALH did not significantly improve the intraoperative performance of the trainees.

The impact of anxiety on postoperative pain following pelvic reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: Despite the prevalence of anxiety, its impact on postoperative pain remains poorly characterized. The present study was aimed at assessing the impact of preoperative anxiety on postoperative pain in patients undergoing pelvic reconstructive surgery. We hypothesized that greater anxiety would be associated with increased postoperative pain for patients undergoing pelvic reconstructive surgery. METHODS: This was a prospective multi-center observational study in Baltimore between September 2018 and June 2019. The Beck Anxiety Inventory was used to assess preoperative anxiety and the validated Surgical Pain Scale instrument was used to assess pain in the postoperative period. The association between anxiety and postoperative pain was analyzed using multivariate logistic regression, adjusting for relevant confounders. RESULTS: A total of 149 patients undergoing pelvic reconstructive surgery completed preoperative surveys. The median age of the study population was 59. The prevalence of preoperative anxiety (anxiety score > 9) in our study population was 26.8% (95% CI 19.7-34.0%). Women with preoperative anxiety reported higher postoperative pain on days 1-2 (relative odds 1.05, 95% confidence interval 1.01-1.10) and day 14 (relative odds 1.53, 95% confidence interval 1.00-2.34). CONCLUSIONS: A large fraction of women undergoing pelvic reconstructive surgery have moderate to severe preoperative anxiety. Women with preoperative anxiety appear to have greater odds of increased postoperative pain. Understanding this association may help surgeons with preoperative counseling and expectations regarding postoperative pain.

Obstructed defecation syndrome in the first week after pelvic reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: Research shows that patients are concerned about postoperative bowel function after pelvic reconstructive surgery. The objectives of this study were to estimate the proportion of patients with obstructed defecation syndrome (ODS), a subtype of constipation, in the week after surgery, to identify associated patient-level and perioperative characteristics and the associated bother. METHODS: Women completed a preoperative and postoperative ODS questionnaire and postoperative bowel diary. Characteristics of women with and without postoperative ODS were compared. Chi-squared or Fisher's exact tests compared categorical variables. Student's t test or Wilcoxon rank-sum tests compared continuous variables. Multivariate logistic regression was assessed for independent effects. Wilcoxon rank-sum tests compared the groups with regard to bother. Spearman correlation coefficients described the relationship among bother, postoperative ODS score, and bowel diary variables. RESULTS: Of the 186 participants enrolled, 165 completed the postoperative ODS questionnaire. Of these, 39 women (23.6%, 95% CI 17.2-30.1) had postoperative ODS. Postoperative ODS was significantly associated with preoperative ODS (p < 0.001), posterior colporrhaphy (p = 0.03), surgery type (p = 0.01), and longer duration of surgery (p = 0.03). Using multivariate logistic regression controlling for age, only preoperative ODS was significantly associated with postoperative ODS (OR 2.68, 95% CI 1.73-4.17). Women with postoperative ODS reported more bother with their defecatory symptoms (p < 0.001). The degree of bother was significantly associated with postoperative ODS score (p < 0.001). CONCLUSION: Using a validated disease-specific questionnaire to identify ODS, this complication was identified in 23.6% of patients in the week after pelvic reconstructive surgery. Preoperative ODS was a significant and important risk factor for this complication.

Virtual Reality Simulation Has Weak Correlation with Overall Trainee Robot-Assisted Laparoscopic Hysterectomy Performance.

STUDY OBJECTIVE: Both simulator practice and intraoperative performance serve to inform surgical trainee training, but the skill transfer from simulation to the intraoperative setting remains unclear. This study evaluates the correlation between trainee performance on virtual reality simulation and (1) overall intraoperative performance during robotic-assisted laparoscopic hysterectomy (RALH) procedures and (2) suturing performance during vaginal cuff closure portion of the case. DESIGN: Retrospective subgroup analysis of randomized controlled trial. SETTING: Academic hospital. PATIENTS: Patients with RALH (N = 29). INTERVENTIONS: Gynecological trainees (N = 21) performed simulation tasks using the da Vinci skills simulator on the day of surgery before performing RALH. Attending surgeons assessed participants' intraoperative performance using Global Evaluative Assessment of Robotic Skills (GEARS). Performance of the vaginal cuff closure step was subsequently assessed using GEARS scoring of anonymized videos. Spearman's correlation was used to quantify the relationship between simulation and intraoperative performances. MEASUREMENTS AND MAIN RESULTS: Trainees achieved a median intraoperative GEARS score of 18.5/30 (interquartile range: 17-22) and a median total simulator score of 84.4/100 (interquartile range: 78.1-87.5). More advanced residents exhibited worse overall simulator performance (median score 86.6/100 compared with 78.8/100, p = .03) and similar intraoperative GEARS scores during overall RALH and vaginal cuff closure compared with less experienced trainees. Total simulation performance score was negatively correlated with GEARS Bimanual Dexterity (ρ = -0.46, p = .02) and Force Sensitivity subscores (ρ = -0.39, p = .05). There was no correlation between total GEARS intraoperative vaginal cuff closure scores and overall simulation performances; however, total Tubes simulation score was correlated with higher GEARS Force Sensitivity subscore (ρ = 0.73, p = .05). CONCLUSIONS: In this study, there was limited correlation between simulation score metrics and trainees' overall intraoperative performance. Furthermore, we identified that GEARS scores could not distinguish between similar trainee skill levels. These findings underscore the need to develop intraoperative assessment tools that can better discriminate different but similar skill levels.

Validation of an obstetric fistula screening questionnaire: a case-control study with clinical examination.

BACKGROUND: Obstetric fistula (OF) is a significant cause of maternal morbidity in lower resource settings where women experience obstructed labor without timely access to skilled obstetric care. The true prevalence of OF is unknown; however, it is estimated to affect 2 to 3.5 million women globally. The Demographic and Health Surveys' (DHS) Fistula Module includes the OF symptom questions most frequently used for prevalence estimates, but these questions have not been validated. The aim of this study is to validate a symptom-based screening questionnaire for OF, including a question in the DHS' Fistula Module. METHODS: With an international panel of fistula surgeons, we developed and face-validated a screening questionnaire that assessed for symptoms of lower urinary tract fistula (LUTF) and lower gastrointestinal tract fistula (LGTF), as well as urinary and fecal incontinence (UI, FI). We evaluated the discriminative ability of the questionnaire using a case-control study design in a 1:2:2 ratio: cases were parous women with fistula confirmed on examination, controls included parous women without fistula on examination, with and without UI symptoms. All women underwent screening for fistula symptoms and a physical examination, with examiners blinded to screening results. RESULTS: Of the 367 Rwandan women who completed the questionnaires and underwent clinical examination, 59 women had LUTFs and 34 had LGTFs, 274 women were classified as controls with and without symptoms of UI. All LUTF screening questions performed well, including the DHS fistula question. The combination of two LUTF screening questions had the highest sensitivity (100%; 95% CI 94%, 100%), specificity (96%; 95% CI 93%, 98%), and area under the curve (AUC) (0.98). The combination of a LGTF screening question and FI question demonstrated the highest sensitivity (97%; 95% CI 85%, 100%), specificity (98%; 95% CI 95%, 99%) and AUC (0.98). CONCLUSIONS: Our OF screening questionnaire, including the DHS fistula question, demonstrated high sensitivities, specificities, and AUC.

Obstetric fistula (OF) is a birth injury which may occur in women living in lower resource settings who experience obstructed labor (not progressing normally) without access to skilled obstetric care. This injury causes a woman to constantly leak urine and/or feces from her birth canal. As OF affects poor women who live far from healthcare it is difficult to fully understand how many women worldwide have an OF. Furthermore, although some Demographic and Health Surveys (DHS) include OF symptom questions, the accuracy of these questions in identifying women with OF has not been studied.To more accurately determine which women may have an OF, we developed an OF screening questionnaire after consulting OF experts worldwide, which included a DHS OF question. We asked women from Rwanda this questionnaire and then examined these women to see if they have OF. Through this process we identified 59 women with a LUTF, 34 with a LGTF, and 274 without an OF. The best performing questions were able to identify women with LUTF 100% of the time and women with LGTF 97% of the time. We also showed that one DHS question detects women with LUTF and LGTF 100% and 85% of the time, respectively. Public health officials can now use the questions we studied to more accurately estimate how many women worldwide have OF, and best direct resources and skilled health care workers to the areas with the greatest need.

The Effect of Social Determinants of Health on Overactive Bladder Symptom Severity.

PURPOSE: Social determinants of health may significantly impact overall health and drive health disparities. We evaluated the association between social determinants of health and overactive bladder severity. MATERIALS AND METHODS: We conducted a multicenter, cross-sectional study of patients presenting to outpatient female pelvic medicine and reconstructive surgery clinics at Montefiore Medical Center (Bronx, New York) and Johns Hopkins Bayview Medical Center (Baltimore, Maryland) from November 2018 to November 2019. Surveys were administered to screen for overactive bladder (Overactive Bladder-Validated 8-Question Screener) and to evaluate social determinants of health. Ordinal logistic regression models were used to examine the association between overactive bladder symptom level and social determinants of health items, while adjusting for age, race, body mass index, parity, history of pelvic surgery and clinical site. RESULTS: A total of 256 patients with a mean±SD age of 58.6±14.2 years and body mass index of 30.4±7.5 kg/m2 were recruited over a 12-month period. Our sample was 33.6% White, 32% Black and 29.3% Hispanic, with 5.1% categorized as other. A higher overactive bladder symptom level was associated with food insecurity (OR 2.51, 95% CI 1.03-6.11), financial strain (OR 1.94, 95% CI 1.06-3.53), difficulty finding or keeping employment (OR 3.14, 95% CI 1.01-9.72) and difficulty concentrating (OR 2.48, 95% CI 1.25-4.95), after adjusting for site, age, race, body mass index, parity and previous pelvic surgery. CONCLUSIONS: In this cross-sectional study, certain social determinants of health were associated with greater overactive bladder severity. Unmet social needs may impact the success of overactive bladder treatment. Urologists should consider collaborating with social work and mental health specialists to better serve patients with overactive bladder and social determinants of health needs.

Rehabilitative care practices in the management of childbirth-related pelvic fistula: A systematic review.

INTRODUCTION AND HYPOTHESIS: Childbirth-related pelvic fistula (CRF) often requires surgery, yet even with successful repair, mental health conditions, musculoskeletal impairments, urinary and fecal incontinence and sexual dysfunction persist for many women. Postoperative rehabilitation, (i.e., physiotherapy, mental health counseling) may address these concerns and has been reported for this population. This review aims to summarize the literature and level of evidence of rehabilitative care practices in fistula care to inform clinical practice, research and policy recommendations. METHODS: A systematic literature review was conducted using Africa-Wide Information, CINAHL, Cochrane, Embase, Global Health, PAIS Index, PubMed and SCOPUS searching keywords and MeSH terms to identify women with CRF admitted for surgery. Two researchers progressively screened titles, abstracts and full-text articles. Eligible articles were classified primary if intervention details and outcomes were reported or secondary if rehabilitation was described, but no specific outcomes reported. Relevant study details, strengths and limitations, and key findings were extracted. RESULTS: Eighteen articles were included: eight primary, ten secondary. Primary articles reported on urethral plugs for postoperative urinary incontinence (UI) (2/8), menstrual cup to manage UI (1/8), physiotherapy and health education (3/8) and mental health counseling (2/8). Secondary articles describe rehabilitation components in the context of program descriptions, qualitative analyses or reviews. All evidence was low or very low quality. CONCLUSIONS: Research on rehabilitative care is very limited and highlights inconsistencies in practice. This review provides support for the feasibility of rehabilitation and establishes the need for future interventional studies that involve a comparator and reliable outcome measures.

Impact of frailty in benign gynecologic surgery: a systematic review.

INTRODUCTION AND HYPOTHESIS: Frailty has been associated with increased risks of perioperative complications. This systematic review explores the associations between preoperative frailty and perioperative complications in benign gynecologic surgery. METHODS: A comprehensive, systematic literature search was conducted using the PubMed interface for Medline, Embase, and Scopus databases through August 12, 2020. Articles were included if they described the utilization of frailty assessment tools in benign gynecologic patients in the pre- or perioperative setting. Study quality and evidence were evaluated by the Cochrane Risk of Bias Tool in Non-Randomized Studies and Grading of Recommendations, Assessments, Development, and Evaluations criteria. RESULTS: One thousand one hundred twenty unique citations were identified, and five studies assessing frailty and perioperative outcomes were included. Three retrospective cohort studies utilized the American College of Surgeons National Surgical Quality Improvement Program database to assess the impact of frailty on perioperative outcomes in hysterectomies and pelvic organ prolapse repair procedures. One retrospective cohort study utilized a California database to assess frailty in prolapse repair surgeries. One cross-sectional study assessed frailty in new urogynecology patient visits. Four of these studies found that preoperative frailty is associated with an increased risk of perioperative complications. Overall, the evidence from the included studies is of low quality and at moderate to critical risk of bias. CONCLUSIONS: There are few studies assessing the impact of frailty on perioperative complications in benign gynecologic surgery. This review demonstrates that preoperative frailty is significantly associated with adverse perioperative outcomes, but additional studies are needed to further explore this association.

Physical performance measures in older women with urinary incontinence: pelvic floor disorder or geriatric syndrome?

INTRODUCTION AND HYPOTHESIS: To evaluate physical performance measures of mobility and functional impairments and assess their association with urinary incontinence (UI) severity and impact on quality of life among older women with UI. METHODS: In a cross-sectional pilot study, 20 women aged ≥ 70 years with UI completed UI questionnaires (Global Impression of Severity, Incontinence Impact Questionnaire [IIQ-7]) and functional status evaluation. Functional status evaluation included the Modified Physical Performance Test (MPPT; range 0-36), Short Physical Performance Battery (SPPB; range 0-12), and other physical performance measures (e.g., Timed Up and Go [TUG]). MPPT and SPPB scores < 32 and < 10, respectively, indicated impaired mobility and function. Descriptive statistics and Spearman correlation coefficients evaluated study variables and associations between UI and physical performance measures. RESULTS: Women were 76.6 ± 4.7 years old with mean body mass index 33.5 ± 9.0 kg/m2. Mixed UI was the most prevalent (n = 17; 85%), and 14 (70%) participants rated their UI as moderate or severe. Low MPPT (< 32) and SPPB (< 10) scores were present in 65% (n = 13) and 35% (n = 7) of participants, respectively. Lower MPPT score (r = -0.46; P = 0.04) and worse TUG performance (r = 0.50; P = 0.03) were associated with greater UI impact on quality of life based on IIQ-7. SPPB did not correlate (P > 0.05) with UI measures. CONCLUSIONS: Mobility and functional impairments are common among older women with UI. Associations between MPPT score and TUG performance with UI impact on quality of life suggest these physical performance measures could be markers of mobility and functional impairments in future research on UI in older women.

Decisions and Consequences: Validation of High-Stakes Simulation-Based Assessments in Gynecologic Surgery.

STUDY OBJECTIVE: Simulation-based assessment is poised for application in educational promotion and credentialing in gynecologic surgery. With high-stakes assessment, validation necessitates evidence, not just about the trustworthiness of decisions but of beneficial consequences to education and healthcare as well. In this paper, we unpack the modern conceptualization of validity as it pertains to surgical simulation and high-stakes competency assessment. DESIGN: N/A SETTING: N/A PATIENTS: N/A INTERVENTIONS: N/A MEASUREMENTS AND MAIN RESULTS: N/A CONCLUSION: Validity in high-stakes simulation-based assessment necessitates evidence, not just about the trustworthiness of score-based decisions but of beneficial consequences to education and healthcare as well.

A Systematic Review of Validity Evidence for the Fundamentals of Laparoscopic Surgery Examination in Gynecology.

OBJECTIVE: The Fundamentals in Laparoscopic Surgery (FLS) examination is designed to test laparoscopic surgery skills. Our aim for this systematic review was to examine validity evidence supporting or refuting the FLS examination specifically as a high-stakes summative assessment tool in gynecology. DATA SOURCES: The data sources were PubMed, MEDLINE, Embase, and Scopus. METHODS OF STUDY SELECTION: The study eligibility criterion was the subject of the FLS examination as an assessment tool in gynecology. We developed a data extraction tool and assigned articles for screening and extraction to all authors, who then abstracted data independently. Conflicts that arose during the extraction process were resolved by consensus. We organized validity evidence for the cognitive and manual skills portions on the basis of the categories of current validation standards. TABULATION, INTEGRATION, AND RESULTS: From 1971 citations identified, 9 studies were included, involving 319 participants. For the cognitive portion of the test, the results were mixed in 5 studies in relationships with the other variables category. For the manual portion of the test, most of the studies focused on the relationships with other variables evidence with mixed findings. The concerning findings in the manual skills portion included the lack of transferability of skills to the operating room, limited mixed evidence for improvement in operating room performance, and worse performance by obstetrics and gynecology surgeons compared with other specialties. We did not find supportive content-based, response process, or consequential evidence in either the cognitive or manual skills portion of the test. CONCLUSION: Validity evidence for the FLS examination was either mixed, as it pertained to relationships with other variables, or lacking in other important evidence categories. Further evidence is required to justify the use of the FLS examination scores as a high-stakes summative assessment.

The changing perception and knowledge of obstetric fistula: a qualitative study.

INTRODUCTION AND HYPOTHESIS: To describe the knowledge and perceptions of obstetric fistula (OF) among affected and unaffected women. METHODS: Twenty-five semi-structured interviews were conducted with women who had received OF repair. Three focus groups were conducted: one group of women with urinary incontinence but no OF, one group of women with OF, and one group of women without genitourinary complaints. Interviews and focus groups were conducted using the grounded theory approach. This study took place in two urban hospitals in Rwanda from April to November 2015. Transcripts were coded using MAXDA11 and analyzed using the axial technique and the constant comparative method. RESULTS: Nearly all participants correctly described OF and its symptoms, and 93% of interviewed women attributed OF to complications in vaginal delivery or cesarean section. Several participants described renouncing stigmatizing beliefs after learning about OF from the radio, health workers, or word of mouth. Still, it was found that women with OF were more knowledgeable about OF etiology than women without genitourinary conditions. CONCLUSIONS: Compared to prior studies, women's knowledge about OF appears to be more medically based, with media and health workers playing a role in reducing stigmatizing beliefs. These findings support continued investment in OF awareness campaigns, which seem to be increasing knowledge about OF and reducing stigma.

Prevalence of symptomatic urinary incontinence and pelvic organ prolapse among women in rural Nepal.

INTRODUCTION AND HYPOTHESIS: Although pelvic floor disorders (PFDs) are a significant public health issue in higher income countries, less is known about these disorders and associated risk factors in low income countries. We aimed to determine prevalence and associated risk factors for stress urinary incontinence (SUI), urge urinary incontinence (UUI), and pelvic organ prolapse (POP) in reproductive age women in Sarlahi District in rural Nepal. METHODS: We conducted a community-based cross-sectional survey of parous, reproductive age women in rural Nepal and screened for pelvic floor disorders using validated screening questions for PFDs. Overall frequency of self-reported symptoms for SUI, UUI, and POP was estimated and compared across demographic and pregnancy history information. RESULTS: Of 14,469 women available for analysis, the mean (SD, range) age was 33.5 (8.2, 13-52) years, and median (range) number of pregnancies was 4 (1-15). The prevalence of SUI was 24.1% (95% CI: 23.3-24.8), of UUI was 13.5% (95% CI: 13.0-14.1), and of POP was 8.0% (95% CI: 7.5-8.4). Bivariate analysis identified the risk of PFD increased incrementally with age and number of vaginal deliveries; these covariates were highly correlated. Multivariable logistic regression revealed age, vaginal deliveries, and previous pelvic surgeries were independently associated with PFD. CONCLUSIONS: PFDs are common in a community of parous, reproductive age women in rural Nepal. Risk factors for these conditions are similar to risk factors found in higher income countries.

Validation of an educational simulation model for vaginal hysterectomy training: a pilot study.

INTRODUCTION AND HYPOTHESIS: The Miya Model ™ (Miyazaki Enterprises, Winston-Salem, NC, USA) was designed as a realistic vaginal surgery simulation model. Our aim was to describe this model and present pilot data on validity and reliability of the model as an assessment tool of vaginal hysterectomy skills. METHODS: We video recorded ten obstetrics and gynecology residents (novice group) and ten practicing gynecologists (expert group) performing vaginal hysterectomy using the Miya model. Blood loss and time taken to complete the procedure were documented. Participants evaluated the model using a postsimulation survey. In addition, two experienced gynecologic surgeons independently evaluated video recordings of each participant's performance using two previously validated global rating scales: Reznick's Objective Structured Assessment of Technical Skill (OSATS) and Vaginal Surgical Skills Index (VSSI). RESULTS: Most participants (80% of novice and 100% of expert group) rated the model as effective or highly effective for vaginal hysterectomy training and assessment. Median time to procedure completion was significantly higher in the novice group, whereas median estimated blood loss was no different between groups. No significant differences were observed in the composite median OSATS or VSSI scores between groups. The interrater reliability indices for subscales and composite scores of the OSATS and VSSI were high and ranged from 0.79 to 0.90 and 0.77 to 0.93, respectively. CONCLUSIONS: With further study, the Miya Model may be a useful tool for teaching and assessing vaginal surgical skills.

Knowledge of pelvic floor disorders in women seeking primary care: a cross-sectional study.

BACKGROUND: Pelvic floor disorders including urinary incontinence (UI) and pelvic organ prolapse (POP) are common conditions; however, most women with these symptoms do not seek care. Failure to seek care may be related to misconceptions about these conditions. The aim of this study was to assess the baseline knowledge of UI and POP among adult women presenting to primary care clinics, as well as factors associated with knowledge levels. METHODS: A survey with questions from previously validated UI and POP knowledge questionnaires (PIKQ-UI and PIKQ-POP, respectively) was self-administered to a cross-sectional group of adult female patients presenting to three primary care clinics: geriatric, community-based, and hospital-based. Participants' demographics and medical histories were compared using ANOVA or Kruskal-Wallis for continuous variables and Chi-square test or Fisher's exact test for categorical variables. In order to compare various covariates with knowledge non-proficiency on PIKQ-UI and PIKQ-POP scales, unadjusted and adjusted ORs with 95% CIs were calculated using bivariate analysis and multivariate logistic regression, respectively. RESULTS: Of 346 participants, knowledge non-proficiency was similar and consistent across clinic sites and reached 72.0% for UI and 53.6% for POP. On multivariate analysis, lower educational attainment, being unaware of UI or POP as medical conditions, and having no history of care-seeking for these conditions were significantly associated with knowledge non-proficiency on UI, POP, or both. CONCLUSIONS: Knowledge non-proficiency for UI and POP is common among women presenting for primary care. For UI, healthcare providers should assess patients' actual understanding of the disease, especially among those with lower educational attainment, to eliminate any possible misconceptions. For POP, the focus should be on increasing awareness of this disease, as many women may have not previously heard of this condition. Simple strategies may increase knowledge in these areas and change care-seeking behaviors. STUDY REGISTRATION: None.

Risk factors for explantation due to infection after sacral neuromodulation: a multicenter retrospective case-control study.

BACKGROUND: Sacral neuromodulation is an effective therapy for overactive bladder, urinary retention, and fecal incontinence. Infection after sacral neurostimulation is costly and burdensome. Determining optimal perioperative management strategies to reduce the risk of infection is important to reduce this burden. OBJECTIVE: We sought to identify risk factors associated with sacral neurostimulator infection requiring explantation, to estimate the incidence of infection requiring explantation, and identify associated microbial pathogens. STUDY DESIGN: This is a multicenter retrospective case-control study of sacral neuromodulation procedures completed from Jan. 1, 2004, through Dec. 31, 2014. We identified all sacral neuromodulation implantable pulse generator implants as well as explants due to infection at 8 participating institutions. Cases were patients who required implantable pulse generator explantation for infection during the review period. Cases were included if age ≥18 years old, follow-up data were available ≥30 days after implantable pulse generator implant, and the implant was performed at the institution performing the explant. Two controls were matched to each case. These controls were the patients who had an implantable pulse generator implanted by the same surgeon immediately preceding and immediately following the identified case who met inclusion criteria. Controls were included if age ≥18 years old, no infection after implantable pulse generator implant, follow-up data were available ≥180 days after implant, and no explant for any reason <180 days from implant. Controls may have had an explant for reasons other than infection at >180 days after implant. Fisher exact test (for categorical variables) and Student t test (for continuous variables) were used to test the strength of the association between infection and patient and surgery characteristics. Significant variables were then considered in a multivariable logistic regression model to determine risk factors independently associated with infection. RESULTS: Over a 10-year period at 8 academic institutions, 1930 sacral neuromodulator implants were performed by 17 surgeons. In all, 38 cases requiring device explant for infection and 72 corresponding controls were identified. The incidence of infection requiring explant was 1.97%. Hematoma formation (13% cases, 0% controls; P = .004) and pocket depth of ≥3 cm (21% cases, 0% controls; P = .031) were independently associated with an increased risk of infection requiring explant. On multivariable regression analysis controlling for significant variables, both hematoma formation (P = .006) and pocket depth ≥3 cm (P = .020, odds ratio 3.26; 95% confidence interval, 1.20-8.89) remained significantly associated with infection requiring explant. Of the 38 cases requiring explant, 32 had cultures collected and 24 had positive cultures. All 5 cases with a hematoma had a positive culture (100%). Of the 4 cases with a pocket depth ≥3 cm, 2 had positive cultures, 1 had negative cultures, and 1 had a missing culture result. The most common organism identified was methicillin-resistant Staphylococcus aureus (38%). CONCLUSION: Infection after sacral neuromodulation requiring device explant is low. The most common infectious pathogen identified was methicillin-resistant S aureus. Demographic and health characteristics did not predict risk of explant due to infection, however, having a postoperative hematoma or a deep pocket ≥3 cm significantly increased the risk of explant due to infection. These findings highlight the importance of meticulous hemostasis as well as ensuring the pocket depth is <3 cm at the time of device implant.