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.

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.

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.

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.

IMACTIV: A Pilot Study of the Impact of Unrestricted Activity Following Urethral Sling Surgery.

OBJECTIVES: To compare continence outcomes and health-related quality of life (HRQOL) among women with limited activity restrictions vs traditional restrictions following mid-urethral sling (MUS) surgery. METHODS: Thirty-six women who underwent MUS surgery were randomized: (1) the Restrictions group was given traditional postoperative restrictions for 6 weeks while (2) the Limited Restrictions group was instructed to resume normal activities other than pelvic rest. Patients undergoing concomitant surgery for Stage III and IV prolapse were excluded. Participants completed questionnaires related to urinary symptoms (UDI-6, IIQ-7) for continence outcomes and HRQOL (SF-12) at baseline, 1 to 6 weeks, 3 months, 6 months, and at least 1 year after surgery. RESULTS: There was no difference in mean scores on the UDI-6 or IIQ-7 between groups at baseline or any time after surgery. The Limited Restrictions group reported better scores than the Restrictions group on the SF-12 mental health component at 1 week (56.7 vs 50.2, P = .01) and 4 weeks (58.4 vs 53.3, P = .04). The Restrictions group reported better SF-12 physical health scores at 5 weeks (55.7 vs 53.0, P = .02) but there was no difference in HRQOL scores between the two groups at any other time. CONCLUSION: In this pilot study, there was no difference in continence outcomes for women with traditional vs limited activity restrictions following MUS surgery. There were differences in HRQOL in the early post-operative period, but these differences were not sustained. Larger prospective studies are needed, but it appears that activity restrictions after MUS surgery may not be necessary.

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.

Assessing the Impact of Urology Resident Involvement on Overall Patient Satisfaction.

INTRODUCTION: To assess the impact of resident participation on patient satisfaction by comparing post-discharge satisfaction scores between academic faculty, private urologists who work with residents, and private urologists with no involvement in resident education. METHODS: Post-discharge Hospital Consumer Assessment of Healthcare Providers and Systems surveys from academic and private urologists at a single institution with an accredited Urology residency program from January 1, 2014 to December 31, 2016 (n = 530) were reviewed. The surveys were de-identified and categorized based on 3 subgroups of providers: academic faculty, private with residents, and private without residents. Overall rating, physician (MD) communication, nursing (RN) communication, discharge information, and overall management during their hospitalization were assessed. RESULTS: The faculty group received an overall patient satisfaction score of 88.3% (percentage of 9 or 10). The private with resident group had an overall satisfaction score of 92.0% and the private without resident group had an overall satisfaction score of 96.7%. There was no statistical difference in patient satisfaction scores between groups across all categories with the exception of MD and RN communication. Private urologists with residents had better MD and RN communication scores than the 2 other groups (p < 0.001, p = 0.013, respectively). CONCLUSIONS: Resident involvement in patient care with faculty or private attendings did not have a negative effect on patient satisfaction scores of any factor measured. Patients were more satisfied with MD and RN communication when residents worked with private attendings.

Risk Factors for Intraoperative Bladder Perforation at the Time of Midurethral Sling Placement.

OBJECTIVE: To evaluate patient-specific and perioperative factors that may be predictive of bladder perforation during midurethral sling placement. METHODS: A retrospective chart review of women who underwent a midurethral sling procedure at our institution between 2013 and 2017 was completed. All cases with bladder perforation were included. Patient demographics and perioperative factors were explored for associations with perforation. Bivariate analysis was used to compare baseline characteristics between those with and without perforation. Logistic regression modeling was used to identify predictors of perforation and associations between bladder perforation and postoperative sequelae. RESULTS: Four hundred and ten women had a urethral sling procedure at our institution between 2013 and 2017. Of these, 35 (9%) had evidence of bladder perforation on cystoscopy. This rate was higher for retropubic slings (15%) compared to transobturator slings (2%). Those with a perforation were younger (54 vs 61 years, P= .004) and had a lower average BMI (24.1 kg/m2 vs 26.3 kg/m2, P = .022). Other risk factors included lack of pre-existing apical prolapse (11% vs 4%, P = .012) and concomitant urethrolysis (27% vs 8%, P = .024). In multivariable analysis, age, BMI, and sling type were significantly associated with perforation. In univariate analysis, perforation was associated with postoperative lower urinary tract symptoms (OR 2.3, P = .21) and urinary tract infection within 30 days of surgery (OR 2.2, P = .047). CONCLUSIONS: Intraoperative bladder perforation was associated with younger patient age and lower BMI. Additionally, bladder perforation is a risk factor for postoperative urinary tract infection and lower urinary tract symptoms.

Recurrent Urinary Tract Infection in Women: Primary Care Referral Patterns in a Tertiary Care Center.

OBJECTIVES: With more than 150 million urinary tract infections (UTIs) diagnosed globally per year, the impact on patient care is significant. We sought to examine appropriateness of management of recurrent UTI before referral to a female pelvic medicine and reconstructive surgery practice, as well as the characteristics of patients referred. METHODS: The medical records of 100 consecutive women with a diagnosis of "recurrent UTI" at a single institution between November 2010 and December 2015 were reviewed. The baseline clinical characteristics, laboratory testing, and treatments before and at referral to the female pelvic medicine and reconstructive surgery were examined by descriptive statistics. RESULTS: The evaluation and treatment patterns for recurrent UTI before specialist referral varied widely. Pelvic examination was performed in only 20.8% of patients before referral. Although most women had at least 1 culture performed (65.2%), treatments were variable. Only 42.7% of patients received recommended first-line antibiotic therapy. At symptom recurrence, only 47.2% of patients received a urine culture; most were empirically treated. Approximately 35.0% of patients received the same antibiotic upon their first recurrence. CONCLUSIONS: A large proportion of patients referred for recurrent UTI to a specialty practice had no prior culture, physical examination, or symptom-specific evaluation before referral. Despite existing guidelines, the evaluation, treatment, and referral patterns for recurrent UTI are highly varied and rarely conform to recommendations. Further studies are needed to confirm these trends and determine interventions to improve the efficacy and efficiency of primary care for women with recurrent UTI.

Identifying Opportunities to Improve Patient Experience With Sacral Neuromodulation: A Human Factors Approach.

OBJECTIVES: To use a human factors approach to conduct a needs assessment of patient preparedness, education, device usability, and satisfaction regarding all stages of sacral neuromodulation therapy and identify opportunities for improvement. Sacral neuromodulation, though minimally invasive, involves an initial testing phase that requires active patient participation. This process is relatively complex and, if a patient does not receive adequate preprocedure education, can be difficult to conceptualize. MATERIALS AND METHODS: Candidates were recruited to participate before undergoing staged sacral neuromodulation. Ten patients were observed, and their experiences were evaluated at 4 phases: (1) date of test implant (Stage I), (2) 5 days following Stage I, (3) date of permanent implant (Stage II), and (4) 3 months following Stage II. Administered questionnaires focused on preoperative preparedness, postoperative satisfaction, and usability. RESULTS: While every patient reported that their symptoms were at least "a little better" postoperatively, they generally had difficulty understanding the risks of the planned procedure, did not know what to expect postoperatively and were unsatisfied with the preoperative materials. Patients struggled with adjusting the settings for their implant devices and usability was considered "below average." Despite overall objective success, 30% of patients indicated that they would not recommend this treatment to friends/family. CONCLUSION: This pilot needs analysis demonstrates several opportunities for improvement in the experience of patients undergoing sacral neuromodulation. These findings highlight the opportunities for a multifaceted intervention to improve patient understanding through the testing phase.

Unsupervised Machine Learning Approaches Reveal Distinct Phenotypes of Perceived Bladder Pain: A Pilot Study.

Interstitial cystitis/bladder pain syndrome (IC/BPS) is defined as an unpleasant sensation perceived to be related to the bladder with associated urinary symptoms. Due to difficulties discriminating pelvic visceral sensation, IC/BPS likely represents multiple phenotypes with different etiologies that present with overlapping symptomatic manifestations, which complicates clinical management. We hypothesized that unique bladder pain phenotypes or "symptomatic clusters" would be identifiable using machine learning analysis (unsupervised clustering) of validated patient-reported urinary and pain measures. Patients (n = 145) with pelvic pain/discomfort perceived to originate in the bladder and lower urinary tract symptoms answered validated questionnaires [OAB Questionnaire (OAB-q), O'Leary-Sant Indices (ICSI/ICPI), female Genitourinary Pain Index (fGUPI), and Pelvic Floor Disability Index (PFDI)]. In comparison to asymptomatic controls (n = 69), machine learning revealed three bladder pain phenotypes with unique, salient features. The first group chiefly describes urinary frequency and pain with the voiding cycle, in which bladder filling causes pain relieved by bladder emptying. The second group has fluctuating pelvic discomfort and straining to void, urinary frequency and urgency without incontinence, and a sensation of incomplete emptying without urinary retention. Pain in the third group was not associated with voiding, instead being more constant and focused on the urethra and vagina. While not utilized as a feature for clustering, subjects in the second and third groups were significantly younger than subjects in the first group and controls without pain. These phenotypes defined more homogeneous patient subgroups which responded to different therapies on chart review. Current approaches to the management of heterogenous populations of bladder pain patients are often ineffective, discouraging both patients and providers. The granularity of individual phenotypes provided by unsupervised clustering approaches can be exploited to help objectively define more homogeneous patient subgroups. Better differentiation of unique phenotypes within the larger group of pelvic pain patients is needed to move toward improvements in care and a better understanding of the etiologies of these painful symptoms.