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.

Food Sensitivities in a Diverse Nationwide Cohort of Veterans With Interstitial Cystitis/Bladder Pain Syndrome.

PURPOSE: Prior studies suggest that certain foods exacerbate interstitial cystitis/bladder pain syndrome symptoms. However, these studies were limited in size and demographics. We assessed the presence of diet sensitivities among patients with interstitial cystitis/bladder pain syndrome and compared them with patients with other pelvic pain conditions and healthy controls. MATERIALS AND METHODS: We identified Veterans Affairs patients nationwide by querying ICD-9/10 codes for interstitial cystitis/bladder pain syndrome. Patients were assigned to interstitial cystitis, other pelvic pain, or healthy control cohorts after chart review. We mailed all patients the Shorter-Moldwin Food Sensitivity Questionnaire to evaluate the self-perceived effects of specific foods/beverages on urinary symptoms and/or bladder pain. RESULTS: In the interstitial cystitis/bladder pain syndrome cohort, 70% had ≥1 food sensitivity vs 37% of the other pelvic pain cohort and 32% of healthy controls (P < .001). The average number of sensitivities were similar between other pelvic pain conditions and healthy control cohorts, which were significantly less than in interstitial cystitis/bladder pain syndrome patients. Interstitial cystitis/bladder pain syndrome patients were more sensitive to acidic, spicy foods, and certain beverages vs other cohorts (all P < .001). Within the interstitial cystitis/bladder pain syndrome cohort, Black patients had significantly higher sensitivity to alcoholic and noncaffeinated beverages than Whites. Black patients did report significantly worsened urinary urgency than Whites (P < .05). CONCLUSIONS: In a diverse population of veterans, interstitial cystitis/bladder pain syndrome patients had significantly more food sensitivities than those without interstitial cystitis/bladder pain syndrome. This suggests that food sensitivities could be suggestive of interstitial cystitis/bladder pain syndrome, which could make the Shorter-Moldwin Food Sensitivity Questionnaire a helpful diagnostic tool and aid in distinguishing interstitial cystitis/bladder pain syndrome from conditions often confused with interstitial cystitis/bladder pain syndrome.

Experiences of Women With Interstitial Cystitis/Bladder Pain Syndrome: What Can We Learn From Women's Online Discussions?

PURPOSE: Interstitial cystitis/bladder pain syndrome is a debilitating chronic condition that disproportionately affects women at a ratio of 5:1. We sought to capture women's experiences with interstitial cystitis/bladder pain syndrome by conducting a large-scale digital ethnographic analysis of anonymous posts on Internet forums. MATERIALS AND METHODS: Online posts were identified using condition-specific keywords and data mining extraction services. Once posts were identified, a random sample of 200 online posts was coded and analyzed by hand using qualitative methods. A Latent Dirichlet Allocation probabilistic topic model was applied to the complete dataset to substantiate the qualitative analysis and allow for further thematic discovery. RESULTS: A total of 6,842 posts written by 3,902 unique users from 224 websites were identified. There was a significant overlap between the hand coding and Latent Dirichlet Allocation themes. Our analysis yielded the following themes: online community engagement, triggers and disease etiologies, medical comorbidities, quality of life impact, patient experience with medical care, and alternative therapies and self-management strategies. Additionally, our population appeared to have a high burden of nonurological associated syndromes. We identified barriers to patient-centered care and found that online peer support was important for women. CONCLUSIONS: Our digital ethnographic analysis is a novel application of qualitative methods using online sources. Social media analytics appears to capture a broader patient population than that typically included in clinic-based qualitative studies, such as patient interviews and focus groups. Understanding patient behaviors and concerns are important to guide strategies for improving care and the overall experience with this difficult-to-treat condition.

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database.

INTRODUCTION: Over 350 000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. MATERIALS AND METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for "Interstim." A random sample of 1000 reports was reviewed and categorized by theme. To corroborate our MAUDE database analysis, a legal librarian searched the Public Access to Court Electronic Records (PACER) database, as well as Bloomberg Law's dockets database for all lawsuits related to SNM devices. RESULTS: Our search of the MAUDE database returned 44 122 SNM-related adverse events (AEs). The figure illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient's need for assistance with device use, followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only four lawsuits: one for patient complications after an SNM device was used off-label, one case of transverse myelitis after implant, one for device migration or poor placement, and the fourth claimed the device malfunctioned requiring removal and causing permanent injury. CONCLUSIONS: This review confirms the real-world safety of SNM devices and very low complication rates as seen in the original clinical trials. Our findings indicate that 43.2% (95% confidence interval 40.1%-46.3%) of SNM "complications" are not AEs, per se, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient, such as battery life. Similarly, the number of lawsuits is shockingly low for a device that has been in the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection-including at least one case in which SNM was used for a non-FDA approved indication-lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation.

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.

Pelvic organ prolapse recurrence after pregnancy following uterine-sparing prolapse repair: a systematic review and meta-analysis.

INTRODUCTION: We sought to determine rates of pelvic organ prolapse (POP) recurrence following pregnancy and delivery in reproductive-age women with prior hysteropexy. METHODS: Scopus, MEDLine, EMBASE, Cochrane Library, and ClinicalTrials.gov databases were searched from inception to May 2020 for combinations of any of the keywords: "pregnancy", "delivery", "fertility", or "cesarean" with a comprehensive list of uterine-sparing surgical procedures for POP repair. Using approach, 1,817 articles were identified describing surgical, uterine-sparing POP repair techniques and subsequent pregnancy and delivery outcomes in reproductive-age women.   RESULTS: Twenty-seven studies describing 218 pregnancies, including 215 deliveries and 3 abortions, were summarized using narrative review and descriptive statistics. Successful pregnancies were reported following a diverse range of uterine-sparing prolapse repairs, both native tissue and mesh-augmented, that utilized vaginal, open abdominal, and laparoscopic approaches. We observed shifts from native tissue repairs to mesh-augmented laparoscopic repairs over time. POP recurrence occurred in 12% of subjects overall, 15% after vaginal and 10% after abdominal prolapse repairs. While meta-analysis identified higher recurrence rates after vaginal delivery (15%) than cesarean section (10%), due to small study numbers, multiple confounders, and heterogeneity between studies, no significant differences in recurrence rates could be identified between vaginal and abdominal surgical approaches, utilization of mesh augmentation, or mode of delivery. CONCLUSION: Although literature on pregnancy following uterine-sparing POP repair is limited, available data suggest that prolapse recurrence after pregnancy and delivery remains similar to that after prolapse repair without subsequent pregnancies with few documented perinatal complications. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021247722.

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.

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.

Updates to Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline.

PURPOSE: In 2019 the American Urological Association (AUA) released the evidence-based guideline "Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline." Information supporting the guideline came from a 2019 systematic evidence review prepared for the AUA by the Pacific Northwest Evidence-based Practice Center (EPC). The AUA used evidence found for 11 Key Questions (Appendix C) in the EPC's report to derive 16 Guideline Statements. In 2021 the EPC conducted an Update Literature Review (ULR) assessing abstracts from new studies published since the 2019 systematic review. The AUA asked the EPC to further assess a subset of studies included in the ULR report, to support potential changes to the 2019 guideline. MATERIALS/METHODS: A systematic-review utilized research from the Oregon Health & Science University. Pacific Northwest EPC was used to update the 2019 AUA Guideline on rUTI in women with new evidence published through 2021. RESULTS: Updates were made to reflect changes in literature since 2019. Updates include recent publications on antibiotic prophylaxis, non-antibiotic prophylaxis, and estrogen therapy. CONCLUSION: The presence of rUTI is crucial to the health of patients and its effects must be considered for the welfare of society. This document will undergo updating as the knowledge regarding current treatments and future treatment options continues to expand. .

Variation in Communication of Competing Risks of Mortality in Prostate Cancer Treatment Consultations.

PURPOSE: Men with prostate cancer prefer patient-specific, quantitative assessments of longevity in shared decision making. We sought to characterize how physicians communicate the 3 components of competing risks-life expectancy (LE), cancer prognosis and treatment-related survival benefit-in treatment consultations. MATERIALS AND METHODS: Conversation related to LE, cancer prognosis and treatment-related survival benefit was identified in transcripts from treatment consultations of 42 men with low- and intermediate-risk disease across 10 multidisciplinary providers. Consensus of qualitative coding by multiple reviewers noted the most detailed mode of communication used to describe each throughout the consultation. RESULTS: Physicians frequently failed to provide patient-specific, quantitative estimates of LE and cancer mortality. LE was omitted in 17% of consultations, expressed as a generalization (eg "long"/"short") in 17%, rough number of years in 31%, probability of mortality/survival at an arbitrary timepoint in 17% and in only 19% as a specific number of years. Cancer mortality was omitted in 24% of consultations, expressed as a generalization in 7%, years of expected life in 2%, probability at no/arbitrary timepoint in 40% and in only 26% as the probability at LE. Treatment-related survival benefit was often omitted; cancer mortality was reported without treatment in 38%, with treatment in 10% and in only 29% both with and without treatment. Physicians achieved "trifecta"-1) quantifying probability of cancer mortality 2) with and without treatment 3) at the patient's LE-in only 14% of consultations. CONCLUSIONS: Physicians often fail to adequately quantify competing risks. We recommend the "trifecta" approach, reporting 1) probability of cancer mortality 2) with and without treatment 3) at the patient's LE.

Do medication prescription patterns follow guidelines in a cohort of women with interstitial cystitis/bladder pain syndrome?

OBJECTIVE: To describe prescription prevalence of oral bladder pain medications among women with interstitial cystitis/bladder pain syndrome (IC/BPS) and to compare with current treatment guidelines. METHODS: We sampled female patients with an ICD-9/10 diagnosis of IC/BPS (595.1/N30.10) by querying active users of the Veterans Health Administration. Medical records were reviewed to determine whether patients met IC/BPS diagnostic criteria. A cohort of women with other pelvic pain disorders was identified. Prescription prevalence of typical non-narcotic oral bladder pain medications was compared between the two groups and healthy controls. Prescription prevalence was also compared before and after the diagnosis of IC/BPS was made using Poisson regression. RESULTS: There were 641 women who met criteria for IC/BPS and 197 women with "Other pelvic pain" disorders. Women with IC/BPS were prescribed a pain medication more often than those with "Other pelvic pain" (77% vs. 59%, p < 0.0001). Of the women with IC/BPS, 44% tried three or more pain medications. Of women with a diagnosis of IC/BPS, only 67% were prescribed an American Urological Association-recommended medication. Prescription prevalence increased after diagnosis for both pentosan polysulfate (10%-29%, p < 0.0001) and hydroxyzine (17%-40%, p < 0.0001), but not for amitriptyline or cimetidine. Amitriptyline was prescribed to 223 women with IC/BPS, only 125 of which (56%) had a documented history of depression. CONCLUSIONS: Many women with IC/BPS required multiple bladder prescriptions, highlighting the difficulty in finding an effective treatment for IC/BPS. Pentosan polysulfate and hydroxyzine were preferred IC/BPS medications. Our next step will be to analyze treatment patterns in those patients who did not receive medications.

Incomplete bladder emptying and urinary tract infections after botulinum toxin injection for overactive bladder: Multi-institutional collaboration from the SUFU research network.

INTRODUCTION: Onabotulinumtoxin A (BTX-A) is an effective therapy for overactive bladder (OAB), however, adverse events may prevent patients from initiating therapy. The study objective was to report real-world rates of incomplete emptying and urinary tract infection (UTI) in men and women undergoing BTX-A for OAB. METHODS: Eleven clinical sites performed a retrospective study of adults undergoing first-time BTX-A injection (100 units) for idiopathic OAB in 2016. Exclusions included: postvoid residual (PVR) > 150 ml, prior BTX-A, pelvic radiation, or need for preprocedure catheterization. Primary outcomes at 6 months were incomplete emptying (clean intermittent catheterization [CIC] or PVR ≥ 300 ml without the need for CIC); and UTI (symptoms with either positive culture or urinalysis or empiric treatment). We compared rates of incomplete emptying and UTI within and between sexes, using univariate and multivariable models. RESULTS: 278 patients (48 men and 230 women) met inclusion criteria. Mean age was 65.5 years (range: 24-95). 35% of men and 17% of women had incomplete emptying. Men had 2.4 (95% CI: 1.04-5.49) higher odds of incomplete emptying than women. 17% of men and 23.5% of women had ≥1 UTI, the majority of which occurred within the first month following injection. The strongest predictor of UTI was a history of prior UTI (OR: 4.2 [95% CI: 1.7-10.3]). CONCLUSIONS: In this multicenter retrospective study, rates of incomplete emptying and UTI were higher than many previously published studies. Men were at particular risk for incomplete emptying. Prior UTI was the primary risk factor for postprocedure UTI.

The Application of Human Factors Engineering to Reduce Operating Room Turnover in Robotic Surgery.

BACKGROUND: Challenges associated with turnover time are magnified in robotic surgery. The introduction of advanced technology increases the complexity of an already intricate perioperative environment. We applied a human factors approach to develop systematic, data-driven interventions to reduce robotic surgery turnover time. METHODS: Researchers observed 40 robotic surgery turnovers at a tertiary hospital [20 pre-intervention (Jan 2018 to Apr 2018), 20 post-intervention (Jan 2019 to Jun 2019)]. Components of turnover time, including cleaning, instrument and room set-up, robot preparation, flow disruptions, and major delays, were documented and analyzed. Surveys and focus groups were used to investigate staff perceptions of robotic surgery turnover time. A multidisciplinary team of human factors experts and physicians developed targeted interventions. Pre- and post-intervention turnovers were compared. RESULTS: Median turnover time was 67 min (mean: 72, SD: 24) and 22 major delays were noted (1.1/case). The largest contributors were instrument setup (25.5 min) and cleaning (25 min). Interventions included an electronic dashboard for turnover time reporting, clear designation of roles and simultaneous completion of tasks, process standardization of operating room cleaning, and data transparency through monthly reporting. Post-intervention turnovers were significantly shorter (U = 57.5, p = .000) and ten major delays were noted. CONCLUSIONS: Human factors analysis generated interventions to improve turnover time. Significant improvements were seen post-intervention with a reduction in turnover time by a 26 min and decrease in major delays by over 50%. Future opportunities to intervene and further improve turnover time include targeting pre- and post-operative care phases.

Rates of Complications and Reoperation after Myomectomy-the Impact of Surgical Approach: A Statewide Population-based Cohort Study from 2005-2018.

STUDY OBJECTIVE: To assess rates of and factors associated with complications and reoperation after myomectomy. DESIGN: Population-based cohort study. SETTING: All non-Veterans Affairs facilities in the state of California from January 1, 2005, to December 31, 2018. PARTICIPANTS: Women undergoing abdominal or laparoscopic myomectomy for myoma disease were identified from the Office of Statewide Health Planning and Development datasets using appropriate International Classification of Diseases, Ninth and Tenth Revision and Current Procedural Terminology codes. INTERVENTIONS: Demographics, surgery facility type, facility surgical volume, and surgical approach were identified. Primary outcomes included complications occurring within 60 days of surgery and reoperations for myomas. Patients were followed up for over an average of 7.3 years. Univariate and multivariable associations were explored between the above factors and rates of complications and reoperation. All odds ratios (ORs) are adjusted ORs. MEASUREMENTS AND MAIN RESULTS: Of the 66 012 patients undergoing myomectomy, 5265 had at least one complication (8.0%). Advanced age, black, Asian race, MediCal and Medicare payor status, academic facility, and medical comorbidities were associated with increased odds of a complication. Minimally invasive myomectomy (MIM) was associated with decreased complications compared with abdominal myomectomy (AM) (OR, 0.29; 95% confidence interval [CI], 0.25-0.33; p <.001). Overall, 17 377 patients (26.3%) underwent reoperation. Medicare and MediCal payor status and medical comorbidities were associated with increased odds of a repeat surgery. Reoperation rates were higher in the MIM group over the entire study period (OR, 2.33; 95% CI, 1.95-2.79; p <.001). However, the odds of reoperation after MIM decreased each year (OR, 0.93; 95% CI 0.92-0.95; p <.001), with the odds of reoperation after AM surpassing MIM in 2015. CONCLUSION: This study identifies outcome disparities in the surgical management of myomas and describes important differences in the rates of complications and reoperations, which can be used to counsel patients on surgical approach. These findings suggest that MIM can be considered a lasting and safe approach in properly selected patients.

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.

Predictors of Colpocleisis Outcomes in an Older Population Based Cohort.

PURPOSE: Colpocleisis is an obliterative surgical option for women with pelvic organ prolapse that is often performed in a frail population. However, because outcomes remain largely unknown we aimed to assess the durability and perioperative safety of colpocleisis in a large population based cohort. MATERIALS AND METHODS: All women undergoing colpocleisis and other pelvic organ prolapse repairs in California (2005-2011) were identified using the Office of Statewide Health Planning and Development data sets. Durability was defined as the absence of future pelvic organ prolapse repair after index repair for the duration of the data sets. Thirty-day morbidity was assessed by identifying readmissions, repeat surgeries and complications. A metric to assess frailty in large administrative databases was applied to assess the impact of frailty on outcomes. Colpocleisis outcomes were compared to other types of pelvic organ prolapse repairs by developing propensity score matched groups. RESULTS: Among the 2,707 women undergoing colpocleisis, reoperation for prolapse occurred in 47 (1.8%). At least 1 complication occurred in 11.1% of the cohort, with serious complications occurring in 2%. Frail patients were more likely to experience any complication (23.3% vs 10.3%, p <0.01) and a serious complication (5.0% vs 1.8%, p=0.02) and was the best predictor of morbidity. Colpocleisis was associated with a more durable repair (overall failure 1.8% vs 3.5%, p <0.01) with no difference in complication rates as compared to the matched cohort. CONCLUSIONS: Colpocleisis provides a more durable outcome than reconstructive pelvic organ prolapse repairs without increased perioperative morbidity. Frailty is a better predictor than age for perioperative complications after colpocleisis.

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.

The Impact of Frailty on Outcomes of Sling Surgery with and without Prolapse Repair.

PURPOSE: Frailty has emerged as a significant predictor of morbidity in urological surgery, but its impact on outcomes of sling surgery for stress incontinence remains unclear. The purpose of this study is to describe the prevalence of frailty among women undergoing sling surgery and determine the association of frailty with 30-day postoperative outcomes. MATERIALS AND METHODS: We analyzed data from the American College of Surgeons National Surgical Quality Improvement Project (NSQIP®) in 2013-2016 to identify patients undergoing sling placement using Current Procedural Terminology, 10th edition, code 57288. Patients were categorized into 2 groups based on whether they underwent isolated sling placement or had a sling with concomitant prolapse surgery. Frailty was assessed using the 5-factor Modified Frailty Index (mFI-5) developed for use with the NSQIP data set. Patients were considered frail if 2 or more factors from the mFI-5 were present. Outcomes and complications within 30 days were captured from the NSQIP data and logistic regression models used to adjust for age, race/ethnicity, body mass index and frailty. RESULTS: We identified 25,887 women who underwent sling placement, 15,087 of whom underwent isolated sling placement (Group 1) and 10,800 of whom underwent sling with concomitant prolapse repair surgery (Group 2). Frailty was present in 9.3% of patients in Group 1 and 10.2% of patients in Group 2 (p=0.0122). Among those who underwent isolated sling placement, frailty was associated with increased length of hospital stay (OR 1.2, 95% CI 1.1-1.4, p=0.0008) and 30-day hospital readmission (OR 1.7, 95% CI 1.1-2.5, p=0.0093). Older patients undergoing isolated sling placement were more likely to have longer operation time (OR 1.2, 95% CI 1.1-1.3, p <0.0001) and hospital length of stay (OR 1.3, 95% CI 1.2-1.4, p <0.0001). Frailty was also associated with increased 30-day hospital readmission in patients who underwent sling with concomitant prolapse repair (OR 1.8, 95% CI 1.3-2.6, p=0.0003), while age was not (OR 0.9, 95% CI 0.7-1.1, p=0.29). CONCLUSIONS: We found that frailty was present in relatively few patients undergoing sling surgery. Adverse postoperative outcomes and complications were low overall. Increased age and frailty were both associated with longer length of stay. Frailty, but not age, was significantly associated with increased likelihood of hospital readmission within 30 days following surgery. Our findings provide insight into the preoperative characteristics of women undergoing sling surgery in a large national sample, suggesting the need for preoperative identification of the frail patient.

Mycoplasma and Ureaplasma Molecular Testing Does Not Correlate with Irritative or Painful Lower Urinary Tract Symptoms.

PURPOSE: For patients with persistent irritative lower urinary tract symptoms, such as dysuria and urinary frequency, evaluation for the atypical organisms Ureaplasma and Mycoplasma has been a common part of care. However, these species are genitourinary colonizers and have not been established as causative pathogens in chronic lower urinary tract symptoms. We therefore sought to evaluate diagnostic testing patterns for Ureaplasma and Mycoplasma and characterize the associations of these bacteria with irritative lower urinary tract symptoms using molecular detection techniques. MATERIALS AND METHODS: Ureaplasma/Mycoplasma testing patterns for 2019 were assessed using an anonymized data repository. Clean catch urine specimens (179) were collected prospectively from female and male patients with and without irritative lower urinary tract symptoms. Quantitative polymerase chain reaction evaluated urinary Ureaplasma and Mycoplasma DNA concentrations, while next-generation sequencing assessed the relative abundance of Ureaplasma and Mycoplasma within the urinary bacterial population. RESULTS: Ureaplasma/Mycoplasma testing was common, with 575 tests performed in 2019 in our community hospital system. In our cohort, Ureaplasma and Mycoplasma were identified in similar proportions in symptomatic and asymptomatic subjects: 25% of female controls and 27% of females with lower urinary tract symptoms and 9.5% of asymptomatic males and 3.3% of men with symptoms (p=0.87 and p=0.91 for females and males, respectively). Regression analysis revealed that both abundance and concentrations of Mycoplasmataceae correlated negatively with a range of irritative lower urinary tract symptoms, including dysuria and urethral pain. CONCLUSIONS: A statistically significant negative correlation of Ureaplasma/Mycoplasma levels with a variety of lower urinary tract symptoms suggests that polymerase chain reaction-based Mycoplasmataceae detection has little diagnostic benefit in assessment of chronic irritative urinary symptoms.

Fear and Frustration among Women with Recurrent Urinary Tract Infections: Findings from Patient Focus Groups.

PURPOSE: We investigated the perspectives of women suffering from recurrent urinary tract infections using patient focus group discussions with an emphasis on patient attitudes toward the current prevention and treatment of urinary tract infection episodes. MATERIALS AND METHODS: Twenty-nine women with recurrent urinary tract infections were recruited from a tertiary urology practice to participate in one of 6 focus groups. Participants were asked questions related to urinary tract infection knowledge, prevention strategies, treatment and impact on quality of life. Grounded theory methods were used to analyze focus group transcripts and identify preliminary themes that describe patient attitudes toward current management strategies for recurrent urinary tract infections. RESULTS: The median age of participants was 46 years (range 20-81). The majority were Caucasian and held a college degree. The 7 preliminary themes identified during discussions fell into 2 categories: 1) negative impacts of taking antibiotics for prevention and treatment of recurrent urinary tract infections, and 2) resentment of the medical profession regarding their management of recurrent urinary tract infections. From the preliminary themes, the emergent concepts of "fear" and "frustration" became evident. CONCLUSIONS: Focus group discussions of women with recurrent urinary tract infections suggest that many women are fearful of the adverse effects of antibiotics and are frustrated with the medical profession for not addressing their fears and optimizing antibiotic stewardship. There is a need for physicians to modify management strategies to address these concerns and to devote more research efforts to improving the nonantibiotic options for prevention and treatment of recurrent urinary tract infections, as well as management strategies that better empower patients.