The impact of resident training on robotic operative times: is there a July Effect?

It is unknown whether the July Effect (a theory that medical errors and organizational inefficiencies increase during the influx of new surgical residents) exists in urologic robotic-assisted surgery. The aim of this study was to investigate the impact of urology resident training on robotic operative times at the beginning of the academic year. A retrospective chart review was conducted for urologic robotic surgeries performed at a single institution between 2008 and 2019. Univariate and multivariate mix model analyses were performed to determine the association between operative time and patient age, estimated blood loss, case complexity, robotic surgical system (Si or Xi), and time of the academic year. Differences in surgery time and non-surgery time were assessed with/without resident presence. Operative time intervals were included in the analysis. Resident presence correlated with increased surgery time (38.6 min (p < 0.001)) and decreased non-surgery time (4.6 min (p < 0.001)). Surgery time involving residents decreased by 8.7 min after 4 months into the academic year (July-October), and by an additional 5.1 min after the next 4 months (p = 0.027, < 0.001). When compared across case types stratified by complexity, surgery time for cases with residents significantly varied. Cases without residents did not demonstrate such variability. Resident presence was associated with prolonged surgery time, with the largest effect occurring in the first 4 months and shortening later in the year. However, resident presence was associated with significantly reduced non-surgery time. These results help to understand how new trainees impact operating room times.

The Role of Vibrators in Women's Pelvic Health: An Alluring Tool to Improve Physical, Sexual, and Mental Health.

INTRODUCTION AND HYPOTHESIS: In limited studies vibrators have been shown to improve sexual function and pelvic floor health; however, there are even fewer studies on the effect of vibrator use on overall genitourinary and mental health. To investigate the effect of regular vibrator use on sexual, genitourinary, and mental health in addition to quality of life. METHODS: We performed a prospective pilot study of women aged 18 to 80 years recruited from a urogynecology clinic. Study participants were instructed to use a vibrator according to the protocol. Sexual function, pelvic floor function, mental health, and pelvic examination were assessed at the initial visit and at 3 months' follow-up using validated questionnaires. RESULTS: Of the 79 participants enrolled in the study, 53 women (66%) completed the study. The mean age of the participants was 54.7 years (range 19-80 years), and the majority of participants were white (n = 59, 74.7%), post-menopausal (n = 48, 60.8%), and not receiving systemic (n = 63, 79.7%) or local (n = 63, 79.7%) hormone therapy. Sexual function significantly improved over time (p = 0.002), whereas the rate of bothersome pelvic organ prolapse symptoms and pain scores significantly decreased (p = 0.034 and 0.0008 respectively). Rates of urge urinary incontinence decreased although this was not statistically significant (p = 0.059). There was a significant improvement in the gross appearance of lichen sclerosus lesions (p = 0.025) and in the severity of vaginal atrophy (p = 0.018). Rates of depression were significantly decreased (p = 0.011). CONCLUSIONS: Vibrator use was associated with improved sexual, genitourinary, and mental health.

Variation in Defining Retention After Onabotulinum Toxin A for Overactive Bladder: A Systematic Review.

IMPORTANCE: Urinary retention is a common adverse effect after intravesical injection of onabotulinum toxin A (BTX) for overactive bladder (OAB). Reported retention rates range from 1.6% to more than 40%. This variation may be due to varying definitions of retention in the literature. OBJECTIVE: We aimed to assess the variation in definitions of urinary retention across studies of BTX for the treatment of OAB. STUDY DESIGN: We performed a systematic review of studies of BTX for OAB by querying MEDLINE and EMBASE according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We included original research studies on adults with overactive bladder treated with BTX and urinary retention reported as an outcome from January 2000 to December 2020. RESULTS: From 954 results, we identified 53 articles that met inclusion criteria. There were 6 definitions for urinary retention. The majority of studies (60.4%) reported initiating clean intermittent catheterization (CIC) as the metric for retention. Five (9.5%) studies provided no definition despite reporting retention as an adverse event. Twenty studies (37.7%) specified a postvoid residual volume (PVR) threshold for initiating CIC in asymptomatic patients; 19 (35.8%) specified a PVR threshold for CIC in symptomatic patients. The PVR thresholds ranged from 100 to 400 mL. Twenty-three studies (43.4%) did not address asymptomatic elevation of PVR, and 22 (41.5%) did not address how symptomatic patients were managed. CONCLUSIONS: Urinary retention after BTX injection is inconsistently defined in the literature. Lack of standardization in reporting retention after intravesical BTX prevents accurate assessment of the risk of urinary retention and comparison of outcomes between studies.

Does MDMA have treatment potential in sexual dysfunction? A systematic review of outcomes across the female and male sexual response cycles.

INTRODUCTION: Sexual health, an integral component of overall well-being, is frequently compromised by common yet underdiagnosed sexual dysfunctions. Traditional interventions encompass pharmaceutical and psychological treatments. Unconventional therapies, like MDMA, offer hope for sexual dysfunction. This review delves into MDMA's effects on sexual responsiveness and its potential role in treating sexual dysfunction. OBJECTIVES: The purpose of this review is to elucidate effects of MDMA on different domains of the female and male sexual response cycles. METHODS: We conducted a systematic review on the effects of MDMA on each domain of the female and male sexual response cycles. PubMed, MEDLINE, and EMBASE were queried, and results were screened using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Search terms utilized were "MDMA" or "ecstasy" in combination with "desire," "arousal," "lubrication," "orgasm," "pleasure," "libido," "erection," and "ejaculation." Inclusion criteria for this review were MDMA use by study subjects and sexual outcomes in at least 1 domain of the female and/or male sexual response cycles were described and measured. Randomized controlled trials, cohort studies (both prospective and retrospective), surveys, and literature reviews published between January 2000 and June 2022 were included. Case reports and studies that did not address conditions of interest were excluded from analysis. Duplicated search results were screened out. The remaining studies were then read in full text to ensure they met inclusion and exclusion criteria for analysis. RESULTS: We identified 181 studies, of which 6 met criteria for assessment of the female sexual response cycle and 8 met criteria for assessment of the male sexual response cycle. Four of 6 studies reported increased sexual desire with MDMA use among women. Arousal and lubrication were improved with MDMA use in 3 of 4 studies, but they were not affected in 1 randomized control study. In men, 7 studies evaluated the effects of MDMA on desire and/or arousal, 5 studies measured impact on erection, 3 on orgasm, and 2 on ejaculation. Sixty percent of interview-based studies reported increased sexual desire in men, while 40% reported mixed or no effect. Two studies reported impairment of erection, 2 reported mixed effects, and 1 reported fear of erection impairment. In both men and women, all studies evaluating orgasm reported delay in achieving orgasm but increased intensity and pleasure if achieved. Primary outcome measures were variable and largely qualitative. CONCLUSION: Our findings suggest that MDMA generally increases sexual desire and intensifies orgasm when achieved. While producing conflicting evidence on sexual arousal in both sexes, MDMA may impair erectile and ejaculatory function in men.

Can vaginal lactobacillus suppositories help reduce urinary tract infections?

INTRODUCTION AND HYPOTHESIS: Recurrent urinary tract infections (rUTIs) are a burden to patients and the health care economy. Vaginal probiotics and supplements have gained significant attention in mainstream media and lay press as a non-antibiotic alternative. We performed a systematic review to determine whether vaginal probiotics are an effective means of prophylaxis for rUTI. METHODS: A PubMed/MEDLINE article search was performed from inception to August 2022 for prospective, in vivo use of vaginal suppositories for the prevention of rUTIs. Search terms included: vaginal probiotic suppository (34 results), vaginal probiotic randomized (184 results), vaginal probiotic prevention (441 results), vaginal probiotic UTI (21 results), and vaginal probiotic urinary tract infection (91 results). A total of 771 article titles and abstracts were screened. RESULTS: A total of 8 articles fit the inclusion criteria and were reviewed and summarized. Four were randomized controlled trials, with 3 of the studies having a placebo arm. Three were prospective cohort studies, and 1 was a single arm, open label trial. Five of the 7 articles that specifically evaluated for rUTI reduction with vaginal suppositories did find a decreased incidence with probiotic use; however, only 2 had statistically significant results. Both of these were studies of Lactobacillus crispatus and were not randomized. Three studies demonstrated the efficacy and safety of Lactobacillus as a vaginal suppository. CONCLUSION: Current data support the use of vaginal suppositories containing Lactobacillus as a safe, non-antibiotic measure, but actual reduction of rUTI in susceptible women remains inconclusive. The appropriate dosing and duration of therapy remain unknown.

"Vagina" Is Not a Bad Word: Historical and Contemporary Censorship of the Word "Vagina".

OBJECTIVE: To characterize instances of censorship of the word "vagina" to better understand perceptions and behaviors surrounding the word. METHODS: Internet and relevant database (PubMed, Academic OneFile, Proquest, Health Business Elite, etc) searches were conducted for the words "vagina," "censor," and related wildcard terms. Search results were filtered by three independent reviewers for relevance. Related articles were summarized and reviewed for common themes. In addition, interviews were conducted with three people who have personal experience with censorship of the word "vagina." Interviews were transcribed and also reviewed for common themes. RESULTS: Examples of censorship of the word "vagina" were compiled, and several themes were identified: (1) Policies surrounding censorship are unclear; (2) Policies appear highly variable; (3) There are differing standards between references to male and female genitalia; and (4) Objections often call the use of "vagina" overtly sexual, profane, or unprofessional. CONCLUSION: The word "vagina" is censored across multiple platforms and policies regarding censorship are inconsistent and unclear. Pervasive censorship of the word "vagina" perpetuates a culture of ignorance and shame about women's bodies. Until we normalize the word "vagina," we cannot make progress on women's pelvic health.

Female sexual health digital resources: women and health care providers need more options.

INTRODUCTION: Female sexual health and female sexual dysfunction (FSD) are usually poorly diagnosed and treated because of the numerous barriers providers and patients face. Internet platforms, such as mobile applications (apps) are potential tools that help overcome these barriers and improve patient access to education and management options for FSD. OBJECTIVES: The aim of this review was to identify existing applications on female sexual health and evaluate their educational content and services. METHODS: We searched the internet and Apple App Store using multiple keywords. A panel of physicians specialized in the treatment of FSD reviewed the apps for content quality, the scientific basis of provided information, interactivity, usability, and whether they would recommend it as a reference tool for patients. RESULTS: Of the 204 apps identified, 17 met the inclusion criteria and were reviewed further. The selected apps were organized into groups based on common themes such as educational (n = 6), emotions and communication (n = 2), relaxation and meditation (n = 4), general sexual health (n = 2), and social and fun (n = 3). All apps from the educational category provided scientific information in collaboration with health experts. When assessed for usability, 1 app received good and 5 received excellent scores based on the System Usability Scale. Most apps (n = 5) provided information on pathology and treatments of orgasmic dysfunction, but only 1 app, created by a physician, provided comprehensive information on all the types of FSD. CONCLUSION: Digital technology could be an effective way to overcome barriers to accessing information and ultimately care for female sexual health. Our review demonstrated that there is still a need for more accessible educational resources addressing female sexual health and FSD for patients and providers.

Three-year patient-reported outcomes of single-incision versus transobturator slings for female stress urinary incontinence are equivalent.

INTRODUCTION AND HYPOTHESIS: Patient-reported outcome measures (PROMs) are important for understanding the success of surgery for stress urinary incontinence, as patient perception of success does not always correlate with physician perception of success. We report PROMS after single-incision slings (SIS) and transobturator mid-urethral slings (TMUS). METHODS: This was a planned outcome analysis of secondary endpoints in a study in which the primary aim was to compare efficiency and safety using a non-inferiority design (results reported previously). In this analysis of quality of life (QOL), validated PROMs were collected at baseline, 6, 12, 18, 24, and 36 months to quantify incontinence severity (Incontinence Severity Index), symptom bother (Urogenital Distress Inventory), disease-specific QOL impact (Urinary Impact Questionnaire), and generic QOL impact (PGI-I; not applicable at baseline). PROMs were analyzed within treatment groups as well as between groups. Propensity score methods were used to adjust for baseline differences between groups. RESULTS: A total of 281 subjects underwent the study procedure (141 SIS, 140 TMUS). Baseline characteristics were balanced after propensity score stratification. Participants had significant improvement in incontinence severity, disease-specific symptom bother, and QOL impact. Improvements persisted through the study and PROMs were similar between treatment groups in all assessment at 36 months CONCLUSIONS: Following SIS and TMUS, patients with stress urinary incontinence had significant improvement in PROMs including Urogenital Distress Inventory, Incontinence Severity Index, and Urinary Impact Questionnaire at 36 months, indicating disease-specific QOL improvement. Patients have a more positive impression of change in stress urinary incontinence symptoms at each follow-up visit, indicating generic QOL improvement.

Robotic Sacrohysteropexy With Concurrent Rectopexy using Fascia Lata Graft.

INTRODUCTION AND OBJECTIVE: There is limited data regarding the use of mesh for pelvic organ prolapse (POP) repair in young women of childbearing age who wish to preserve their uterus.1 Sacrohysteropexy with concurrent rectopexy can be performed in this population with a biologic graft, to decrease the risk of contamination with colorectal surgery and allow for future pregnancy.2-4 The objective of this video is to present the surgical management of prolapse repair in a young woman with uterine and rectosigmoid prolapse, causing rectal outlet obstruction. MATERIALS AND METHODS: Our patient is a 21-year-old woman with over a decade of severe constipation. Her past medical history includes anxiety, depression and sexual abuse. She previously underwent robotic rectopexy for intra-rectal intussusception and mucosal prolapse with immediate improvement in her symptoms; however, two months after rectopexy, she suffered from persistent abdominal pain and severe difficulty passing stool. Dynamic resonance imaging demonstrated descent of the bladder with significant uterine prolapse, causing impingement of rectum and rectocele, blocking the evacuation of stool. The patient was thus indicated for concurrent sacrohysteropexy and rectopexy. RESULTS: She underwent a robotic procedure. Given her age, in an effort to preserve future child-bearing potential, we performed the surgery with a biologic graft made of fascia lata. For the sacrohysteropexy, the graft was sutured to the posterior cervix. Intraoperatively she was noted to have an intact enterocele repair and posterior rectopexy from her previous surgery; however, there was an angulation at the recto sigmoid. This was corrected by performing a rectopexy to the fascia lata graft. She discharged home the day of surgery without incident. CONCLUSION: Biologic grafts can be used for multi compartment prolapse repair in women of child-bearing age. Fascia lata provides a safe alternative to mesh to allow for future pregnancy. Also, sacrohysteropexy with concurrent rectopexy can be performed with same day discharge.

Manufacturer and User Facility Device Experience Reporting of Events Related to Transvaginal Mesh: Understanding the Data.

OBJECTIVE: The aim of this study was to examine potential bias in reports to the Manufacturer and User Facility Device Experience (MAUDE) database involving vaginal mesh by identifying the party submitting the report, the nature of the complaints, and whether the reports were edited. METHODS: All reports submitted to the MAUDE database involving synthetic transvaginal mesh from January 2000 through December 2017 (40,266 safety reports) were identified. A random 2% sample (900) of these reports was reviewed in depth to determine the specific relevant details, including reporter type (patient, manufacturer, lawyer) and details of the complaint/injury. RESULTS: Of the 40,226 reports to MAUDE identified, 28,473 (70.7%) were sling reports, and 11,793 (29.3%) described mesh products augmenting pelvic organ prolapse repair. Of the 900 reports reviewed in depth, 46%, 41%, 10%, and 2% of entries were reported by the manufacturer, attorney, health care provider, and patients, respectively. In the 4 years after submission, 18.6% of reports were modified at least once. CONCLUSIONS: The MAUDE database allows physicians, manufacturers, and patients to immediately report adverse events experienced due to medical devices. While this database is an important means to identify potential danger to patients, any individual can file a report and, thus, it should not be the sole source of evidence to consider when assessing device safety. Further, the MAUDE database provides no information into the total number of cases performed without complication.

Seeking the Truth About Primary Elective Cesarean Delivery and Pelvic Floor Disorders: A Systematic Review and Meta-Analysis.

IMPORTANCE: A better understanding of the effect of elective cesarean delivery (CD) on the development of pelvic floor disorders can help obstetricians counsel pregnant women. OBJECTIVE: This study aimed to perform a systematic review and meta-analysis evaluating whether primary elective CD is protective against pelvic floor disorders. STUDY DESIGN: Using the MOOSE criteria, electronic databases were searched for studies that compared the prevalence of pelvic floor disorders among primiparous women. Outcomes of interest were urinary incontinence (UI), fecal incontinence (FI), anal incontinence (AI), and pelvic organ prolapse (POP). Comparisons were made between CD before the onset of labor ("Elective CD"), CD after trial of labor ("Labor CD"), and vaginal delivery (VD). Risk ratios (RRs) were computed using STATA. Between-study heterogeneity was assessed via Cochrane's homogeneity test and review of the I2 statistic. RESULTS: Nineteen studies were included. The overall prevalence of UI for Elective CD was estimated at 7% (95% confidence interval [CI], 3%-13%), Labor CD at 14% (95% CI, 8%-21%), and VD at 26% (95% CI, 20%-32%). Meta-analysis demonstrated a decreased risk of UI after Elective CD compared with Labor CD (RR, 0.75; P = 0.011) or VD (RR, 0.43; P < 0.001). There was a decreased risk of FI or AI after Elective CD compared with VD, but not when compared with Labor CD. Only 2 studies examined POP, precluding meta-analysis. CONCLUSIONS: Among primiparous women, Elective CD may be protective against UI when compared with Labor CD. There was not a protective effect of Elective CD against FI and AI when compared with Labor CD. More data on the effect of elective CD on POP are needed.

A Human Factors Approach to Vaginal Retained Foreign Objects.

STUDY OBJECTIVE: This study aimed to apply a structured human factors analysis to understand conditions contributing to vaginal retained foreign objects (RFOs). DESIGN: All potential vaginal RFO events from January 1, 2000, to May 21, 2019, were analyzed by trained human factors researchers. Each narrative was reviewed to identify contributing factors, classified using the Human Factors Analysis and Classification System for Healthcare. SETTING: An 890-bed, academic medical center in Southern California. PATIENTS: Patients who underwent a vaginal procedure in which a vaginal RFO-related event occurred were included in this study. However, no patient information was included, and only the relevant details from their procedures were included. INTERVENTIONS: No interventions were developed or implemented. MEASUREMENTS AND MAIN RESULTS: Over the 19-year period, 45 events were reported. The most common items were vaginal packing and vaginal sponges (53.33%). Less frequently retained items involved broken instruments (20.20%). Most cases were laparoscopic hysterectomies or vaginal deliveries. Based on the Human Factors Analysis and Classification System, 75 contributing factors were identified, consisting primarily of preconditions for unsafe acts (communication challenges, coordination breakdowns and issues with the design of tools/technology) and unsafe acts (errors). CONCLUSION: Although rare, vaginal RFOs do occur. The top 2 contributing factors were skill-based errors and communication breakdowns. Both types of errors can be addressed and improved with human factors interventions, including simulation, teamwork training, and streamlining workflow to reduce the opportunity for errors.

The Impact of Provider Sex and Experience on the Quality of Care Provided for Women with Urinary Incontinence.

BACKGROUND: Although specialists are skilled in the management of urinary incontinence, primary care clinicians are integral in early diagnosis and initiation of management in order to decrease overuse of specialty care and improve the quality of specialist visits. We measured the quality of incontinence care provided by primary care clinicians prior to referral to a specialist and evaluated the impact of provider variables on quality of care. METHODS: We performed a retrospective review of 200 women referred for urinary incontinence to a Female Pelvic Medicine and Reconstructive Surgery specialist between March 2017 and July 2018. We measured primary care adherence to 12 quality indicators in the 12 months prior to specialist consultation. We stratified adherence to quality indicators by clinician sex and years of experience. RESULTS: Half of women with incontinence underwent a pelvic examination or had a urinalysis ordered. Few patients with urge urinary incontinence were recommended behavioral therapy (14%) or prescribed medication (8%). When total aggregate scores were compared, female clinicians performed the recommended care 47% ± 25% of the time, compared with 35% ± 23% for male clinicians (P = .003). Increasing years of experience was associated with worse overall urinary incontinence care (r -0.157, P = .02). CONCLUSIONS: We found low rates of adherence to a set of quality indicators for women with urinary incontinence, with male clinicians performing significantly worse than female clinicians. Improvement of incontinence care in primary care could significantly reduce costs of care and preserve outcomes.

Defining Properly Collected Urine: Thresholds to Improve the Accuracy of Urinalysis for Microscopic Hematuria Evaluation in Women.

PURPOSE: Microscopic hematuria is one of the most common office consults for urologists. While revised guidelines have risk-stratified patients to reduce unnecessary screening, they do not provide guidance concerning specimen quality. We sought to define "properly collected" specimens using catheterized urine samples as a reference to improve the utility of hematuria screening in women. MATERIALS AND METHODS: We prospectively acquired same-visit voided and catheterized urine samples from 46 women referred for microscopic hematuria from September 2016 to March 2020. Characteristics of pre-referral urinalysis were compared to the matched specimens. True microscopic hematuria was defined as ≥3 red blood cells per high power field on catheterization. RESULTS: Catheterized urinalyses had significantly fewer red blood and squamous epithelial cells in comparison to both referral urinalyses (p=0.006, p=0.001, respectively) and same-day void urinalyses (p=0.02, p=0.04, respectively). As no catheterized sample had >2 squamous epithelial cells, we applied this squamous epithelial cell threshold to referral urinalyses for analysis. Addition of this criterion for "properly collected specimen" increased the positive predictive value of referral urinalyses from 46.1% to 68.8% for true microscopic hematuria. Fewer than 2 squamous epithelial cells with elevated RBC was a significant predictor for true microscopic hematuria (p=0.003). CONCLUSIONS: Voided specimens in the urology clinic had significantly lower red blood cells than referral samples, indicating improved collection technique may reduce false positive urinalyses. Matched collection suggested that repeat collection by catheterization in women who present with >2 squamous epithelial cells per high power field on referral urinalysis may prevent unnecessary future work-up.

Supracervical Hysterectomy Is Protective against Mesh Complications after Minimally Invasive Abdominal Sacrocolpopexy: A Population-Based Cohort Study of 12,189 Patients.

PURPOSE: Although minimally invasive (robotic or laparoscopic) abdominal sacrocolpopexy (MISC) has become the new gold standard for durable pelvic organ prolapse repair after the vaginal mesh controversy, current literature is limited. Our objective was to study reoperation for mesh complications after MISC. MATERIALS AND METHODS: All women undergoing MISC in California from January 2012 to December 2018 were identified from Office of Statewide Health Planning and Development data sets using appropriate ICD-9/10 (International Classification of Diseases 9th/10th Revision) and CPT® (Current Procedural Terminology) codes. Univariate and multivariable analyses were performed to assess associations between patient demographics, surgical details and our primary outcomes: rates of reoperation for a mesh complication. RESULTS: Of 12,189 women undergoing MISC 8,398 (68.9%) had concomitant hysterectomy. Total hysterectomy (TH) and supracervical hysterectomy (SCH) were performed in 5,027 (41.2%) and 3,371 (27.6%) cases, respectively. Reoperation rates for mesh complications were lower after SCH vs TH (overall: 0.7%, mean followup time 1,111 days vs 3.1%, mean followup time 1,095 days, p <0.001; subcohort with at least 4 years of followup: 2.1% vs 8.9%, p <0.001). Additionally, mesh complication rates were higher even if TH was performed remotely, as compared to concomitant SCH (5.2% vs 0.7%, p <0.001). The increased risk for reoperation due to mesh complications after TH was preserved on multivariable analysis (OR 4.20, 95% CI 2.72‒6.50, p <0.001). CONCLUSIONS: Concomitant TH at time of MISC is associated with a significantly higher rate of mesh complication as compared to SCH. The increased risk of a mesh complication associated with TH is present even if the TH was performed prior to the MISC.

Female Sexual Function following Sling Surgery: A Prospective Parallel Cohort, Multi-Center Study of the Solyx™ Single Incision Sling System versus the Obtryx™ II Sling System.

PURPOSE: Limited data exist regarding sexual function after single incision sling (SIS) surgery. We compared sexual function 36 months postoperatively between patients undergoing SIS and transobturator sling (TMUS) for treatment of stress urinary incontinence. MATERIALS AND METHODS: Assessment of sexual function was a planned secondary objective of this prospective, multi-center study that enrolled women to Solyx SIS or Obtryx II TMUS. The primary study aim was to compare efficacy and safety using non-inferiority design at 36 months. Patient-reported outcomes of sexual function were assessed at baseline and 6, 12, 18, 24 and 36 months using Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Changes in sexual function were analyzed within and between groups. Outcomes for patients requiring surgical retreatment were determined. RESULTS: Baseline characteristics were balanced using propensity score stratification (N=141 SIS, N=140 TMUS). Groups were similar in age, body mass index and concomitant surgery performed. Average length of followup was 30 months. Baseline sexual activity was similar (123/141 SIS, 114/140 TMUS, p=0.18). Severity of urinary incontinence did not correlate with baseline sexual activity. Mean PISQ-12 scores increased significantly from baseline to 36 months for both groups, indicating better sexual function at each visit. There were no significant differences in PISQ-12 scores between groups except at 36 months, where the difference was small (-2.5, 95% CI [-4.7, 0.2]). Among patients undergoing surgical retreatment (9/281, 3%), improvement in sexual function was maintained. De novo dyspareunia was rare following both treatments (SIS 1/141, TMUS 0/140, p=1.00). CONCLUSIONS: Patients have significant improvement in sexual function after SIS and TMUS. De novo sexual pain is low after sling surgery.

Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database.

PURPOSE: We sought to describe and analyze the adverse events associated with synthetic male slings reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: We queried the MAUDE database for all entries including the terms "Male Sling," "InVance," "Virtue," or "Advance" from January 1st, 2009 to December 31st, 2018. We collected and analyzed information about the event type, date received, report source, source type, and manufacturer. We reviewed and categorized the event description text for each medical device report (MDR). RESULTS: A total of 497 adverse events related to the male sling were identified. The adverse events were classified as injury (95.4%), malfunction (4.2%), and other (0.4%). There were no deaths described. The slings involved were the Advance or Advance XP sling (69.8%), InVance (15.5%), Virtue Quadratic (12.3%), or unknown (2.4%). The 4 most common adverse events described were urinary incontinence (46.7%), sling erosion (9.1%), mechanical malfunction (8.2%), and pain/numbness (8.2%). There was no increase in the number of reports in the years following the FDA warnings for urogynecologic mesh. CONCLUSION: There was an overall modest number of MDRs related to male slings and the majority of them were reported by the manufacturer. The reporting of adverse events for male slings does not seem to be affected by the controversy and scrutiny towards transvaginal mesh and midurethral slings. Further clinical studies and more objective and detailed databases are needed to investigate the safety of these synthetic slings.

Applying a Human Factors Approach to Improve Patient Experience with Sacral Neuromodulation.

OBJECTIVES: To apply a human factors approach, the study of interactions between humans and complex systems, to investigate patient preparedness, satisfaction, and perceived usability with sacral neuromodulation (SNM) and develop interventions aimed at improving patient experience. MATERIALS AND METHODS: Ten patients with overactive bladder undergoing staged SNM were observed, and data including pre-operative preparedness, satisfaction, perceived usability and barriers impacting patient experience were collected. Interventions were developed and an additional ten patients were observed. All patients were English-speaking and at least 18 years of age. RESULTS: Pre-intervention patients had difficulty understanding the risks of the procedure, did not know what to expect post-operatively and were unsatisfied with pre-operative materials. Interventions included: A pre-procedure educational video and informational sheet, detailed discharge instructions; and a nursing inservice. Pre-operative preparedness (Stage I: U = 100, z = 3.785, P = .000; Stage II: U = 80, z = 2.864, P = .003), post-operative satisfaction (Stage I: U = 100, z = 3.788, P = .000; Stage II: U = 77.5, z = 2.665, P = .006.) and perceptions of usability (Stage I: U = 77.00, z = 2.056, P = .043.; Stage II: U = 80.50, z = 2.308, P = .019) increased significantly after the intervention. CONCLUSION: Our observations highlight the value of implementing a human factors approach to identify and mitigate barriers impacting patient experiences with SNM. Through the implementation of systems-level interventions (ie, interventions that impact the non-clinical aspects of surgery such as patient and/or staff education), significant improvements can be made.