Adverse Event Reporting of Commonly Used Gender-Specific Implantable Medical Devices in the United States.

BACKGROUND: Evidence suggests that more women are harmed by implantable medical devices than men. It is unknown whether this difference includes gender-specific devices. METHODS: In this study, we examine the differences in reported adverse events between 6 female- and 5 male-specific implantable devices from the Manufacturer and User Facility Device Experience (MAUDE) database from 1993 to 2018. Primary endpoints were injury type (life-threatening, disability, death) and the rate of device evaluation by the manufacturer. Proportions of valid entries across these variables were compared using either the Fisher exact test or χ2 test. RESULTS: Female-specific devices had higher rates of life-threatening outcomes (1.6% versus 0.3%, P < 0.001), disabilities (5.0% versus 4.3%, P < 0.001), and deaths (0.6% versus 0.1%, P < 0.001) compared with the male-specific devices. Of the 8159 devices that were evaluated by the manufacturer, 56% were female specific while 44% were male specific. Female-specific devices were evaluated far less frequently by the manufacturer (4.5% versus 38.2%, P < 0.001). CONCLUSIONS: Increased adverse events reports for female-specific devices and associated high-grade complications necessitates improved postmarket surveillance.

An Evaluation of Sexual Function in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men Treated with the Temporarily Implanted Nitinol Device.

Purpose: To document the effect of the temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Israel) on sexual function from a multicenter, randomized, single-blinded, sham-controlled trial. Materials and Methods: Men were randomized 2:1 between iTind and sham procedure arms. The iTind was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 3, and 12 months postoperatively using the Sexual Health Inventory for Men (SHIM) and International Index of Erectile Function (IIEF). Unblinding occurred at 3 months. Results: We studied 185 men with a mean age of 61.1 ± 6.5 years. There was no difference in SHIM or total IIEF between iTind and sham at 3 months or in the iTind arm at 12 months compared with baseline. Men in the iTind arm without erectile dysfunction at baseline showed an improvement in total IIEF score of +6.07 ± 21.17 points (p = 0.034) at 12 months, in addition to an improvement in ejaculatory function. SHIM scores remained unchanged in all groups, regardless of age, prostate volume, or baseline erectile function. Conclusion: No changes were observed in sexual and ejaculatory function of patients with iTind regardless of a man's age, prostate volume, and baseline sexual function. Clinicaltrials.gov: NCT02506465.

Development of a North American coordinated registry network for surgical treatment of benign prostatic hyperplasia.

PURPOSE: To create a prospective, multicenter coordinated registry network (CRN) of robust "real world" data for benign prostatic hyperplasia (BPH) that links surgical practices to objective and subjective outcomes of patients who undergo surgery for the improvement in lower urinary tract symptoms (LUTS) secondary to BPH. METHODS: We gathered a group of BPH experts from various institutions to identify the minimum core data elements needed to assess BPH procedures. To achieve consensus on the data elements, we used a Delphi method adaptation, in which a series of surveys were answered by the expert panel individually and anonymously. Survey results were collected and analyzed. Questions for the following round were based on response analysis from the prior survey. This process was repeated until consensus was achieved. RESULTS: Participation rates in the first and second rounds were 100% and 90%, respectively. The expert panel reached consensus on 148 data elements out of the 182 proposed, capturing patient medical and surgical history, procedure, discharge, short- and long-term follow-up, device factors, surgery, and surgeon factors. CONCLUSION: We have successfully developed a set of core data elements to support the study of BPH surgical therapies by gathering an expert panel on BPH and using the Delphi method. These data elements influence provider decisions about treatment and include important outcomes related to efficacy and safety.

Use of the penile cuff test to diagnose bladder outlet obstruction: A systematic review and meta-analysis.

PURPOSE: Among noninvasive modalities for assessing bladder outlet obstruction (BOO), the penile cuff test (PCT) is the most used in clinical practice. The purpose of this review was to evaluate the performance of PCT in diagnosing and managing BOO. MATERIALS AND METHODS: PubMed, Scopus, CINAHL, Embase, Cochrane Library, and Web of Science were searched for studies investigating use of PCT for BOO. Studies evaluating diagnostic parameters, inter-observer agreements, or treatment outcomes using PCT were included. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocol was followed (PROSPERO ID: CRD42022300047). A proportional meta-analysis was done for diagnostic accuracy proportions. The Egger's and the Begg-Mazumdar rank-correlation tests were used to assess publication bias. Risk of bias was assessed using the Gradings of Recommendations, Assessment, Development, and Evaluations (GRADE) criteria. RESULTS: Of the 272 articles retrieved, 17 were included in qualitative synthesis and meta-analysis was performed on five studies (comprising 448 patients). Two studies evaluating inter-observer agreement demonstrated 95% agreement and five studies evaluating procedures reported a 66%-80% surgical success rate on obstructed patients using PCT. From the proportional meta-analysis, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 0.85 (95% CI 0.71-0.95) 0.78 (95% CI 0.67-0.87), 0.74 (95% CI 0.52-0.91), and 0.87 (95% CI 0.73-0.96), respectively. Publication bias was noted for PPV but not for sensitivity, specificity, or NPV. Based on the GRADE criteria, there were two low, six moderate, and nine high-quality studies. CONCLUSIONS: PCT performs sufficiently in diagnosing and managing BOO. However, due to variability in obstruction criteria assessment, more studies comparing diagnostic criteria are warranted.

A Community-Based Education Program for Overactive Bladder in a Predominantly Minority Older Female Population: A Pilot Study.

INTRODUCTION: Knowledge gaps regarding available treatment and social stigmatization are barriers to care in patients with overactive bladder (OAB). We assessed the feasibility of an OAB education program targeting older community-dwelling females. METHODS: Community-dwelling women over 55 years old were recruited. Eligible participants underwent an education program covering continence-promotion strategies. The Overactive Bladder Questionnaire-Short Form and Short Form-12 were completed at baseline, 1 week, 3 months, and 6 months post-intervention to measure symptom bother and condition-specific and general quality of life (QoL). Data were analyzed using a linear mixed-effects model for repeated measures. RESULTS: Thirty-seven female patients with OAB symptoms at baseline were assessed with the majority from Latino/Hispanic or Black/African American ethnic/racial backgrounds. For our youngest subgroup (≤68 years old), significant improvements were observed at 3 and 6 months compared to 1 week post-intervention for symptom bother (3 months, -22.75, p = 0.006; 6 months, -25.76; p = 0.001) and condition-specific and health-related QoL subscale scores for concern (3 months, +23.76, p = 0.006; 6 months, +22.15, p = 0.011) and social interaction (3 months, +21.11, p = 0.017; 6 months, +20.51; p = 0.021). For all age subgroups, improvements in general QoL measures for mental health were seen at 3 and 6 months compared to baseline (3 months, +7.57, p = 0.02; 6 months, +6.70; p = 0.048). CONCLUSIONS: Statistically significant improvements in symptom bother, condition-specific, and general QoL measures were observed following an OAB education program pilot study in a predominantly minority female population. Further studies are needed to support efficacy and optimize program design.