Wolter, Christopher

ABSTRACTAimsThis study aimed to determine the efficacy and safety of iltamiocel investigational autologous muscle cell therapy in females with stress urinary incontinence (SUI).MethodsAdult females were randomized 2:1 to iltamiocel (150 × 106 cells) or placebo and stratified by severity and prior SUI surgery. The primary objective was efficacy based on the frequency of stress incontinence episodes (SIE) recorded in a 3‐day diary at 12 months posttreatment. After 12 months, placebo participants could elect to receive open‐label iltamiocel. Efficacy and safety analyses were performed using all patients as treated populations.ResultsThe study enrolled 311 patients, 297 were randomized to either iltamiocel (n = 199) or placebo (n = 98). Of the 295 participants that completed 12 months blinded follow‐up, the proportion achieving the primary endpoint of ≥ 50% SIE reduction was not statistically different between treatment groups (52% vs. 53.6%; p = 0.798). A significantly greater proportion of iltamiocel participants in the prior SUI surgery stratum group achieved ≥ 75% SIE reduction compared with placebo, (40% vs. 16%; p = 0.037). Treatment response was maintained at 24 months in 78.4% and 64.9% of iltamiocel participants who achieved ≥ 50% and ≥ 75% SIE reduction, respectively, at Month 12. Adverse events related to the treatment were reported in 19 (9.5%) iltamiocel participants and 6 (6.1%) placebo participants.ConclusionThe study did not meet its primary endpoint however, iltamiocel cell therapy is safe and may be ideally suited to female patients who have undergone prior surgery for SUI. Additional study in this group of patients with high unmet medical needs is warranted.Trial RegistrationClinicalTrials.gov identifier: NCT01893138; EudraCT number: 2014‐002919‐41.

Abstract Purpose: To assess the quantitative and qualitative components of in-person focus groups as a potential intervention for female patients with urinary incontinence.Methods: Women over the age of 18 seeking treatment for UI were randomized to standard care with focus group participation or to standard care alone. All participants completed validated questionnaires: MESA, UDI-6, OAB-SAT-q, PGI-S, PGI-I, SQoL-F, PHQ-9, IPAQ at the beginning and conclusion of the study. Questionnaires were analyzed with repeated measures of ANOVA models in an intention-to-treat manner. Three moderated focus group sessions were held and audio recorded. Recordings were transcribed and categorized by frequency into themes using grounded theory methodology. Results: A total of 10 control and 8 intervention participants agreed to participate. Seven women attended all three focus group sessions and were included in the final analysis. Transcripts from focus group sessions observed women identified most with (1) urinary incontinence (UI) as a chronic disease, (2) shame managing UI, and (3) social constraints of toileting. Participants self-reported appreciation of focus group participation and desire for on-going sessions. Analysis of the questionnaires did not demonstrate statistically significant differences.Conclusion: Data ascertained from questionnaires was unable to demonstrate a meaningful effect in improved treatment outcomes for control and intervention participants. Grounded theory analysis of transcripts identified four primary themes: (1) appreciation of the focus group, (2) UI as a gendered issue, (3) lack of public awareness, and (4) history of negative provider interactions. All focus group participants self-reported interest in attending future focus group sessions.

Abstract Background To assess the feasibility and acceptability of in-person support groups as a potential intervention for female patients with urinary incontinence. Methods Women over the age of 18 seeking treatment for UI were randomized to standard care with support group participation or to standard care alone. All participants completed validated questionnaires at the beginning and conclusion of the study. Questionnaires were analyzed with repeated measures of ANOVA models in an intention-to-treat manner. Three moderated support group sessions were held and audio recorded. Recordings were transcribed and categorized by frequency into themes using grounded theory methodology. Results A total of 10 control and 8 intervention participants agreed to participate. Seven women attended all three support group sessions and were included in the final analysis. Transcripts from support group sessions observed women identified most with (1) urinary incontinence (UI) as a chronic disease, (2) shame managing UI, and (3) social constraints of toileting. Support participants self-reported appreciation of support group participation and desire for on-going sessions. Analysis of the questionnaires did not demonstrate statistically significant differences. Conclusion Data ascertained from questionnaires was unable to demonstrate a meaningful effect in improved treatment outcomes for control and intervention participants. Grounded theory analysis of transcripts identified four primary themes: (1) appreciation of the support group, (2) UI as a gendered issue, (3) lack of public awareness, and (4) history of negative provider interactions. All support group participants self-reported interest in attending future support group sessions.

Introduction Prevalence rates of pelvic floor disorders in women in nonmetropolitan communities compared with metropolitan communities are unknown. We hypothesize that the rates are higher in women in nonmetropolitan communities. Methods We accessed the health survey data from the NHANES (National Health and Nutrition Examination Survey) from 2009 to 2010 divided by geocodes into nonmetropolitan (<50,000 inhabitants) and metropolitan communities (>50,000). Responses were analyzed for the following conditions: urinary incontinence and nocturia, bowel urgency and anal incontinence, and symptomatic vaginal bulge. Age-adjusted prevalence rates were estimated using logistic regression. Results The 2009–2010 NHANES survey was completed nationwide by 302 women in nonmetropolitan communities and 2201 women in metropolitan communities. Overall, prevalence rates of PFDs did not significantly differ between groups. Prevalence rates of urinary incontinence and nocturia at least weekly were similar between metropolitan and nonmetropolitan groups (16.2% vs 14.6%, P = 0.47), with stress incontinence being more common than urgency and other types of incontinence (40% vs 23% and 8%). Women in metropolitan communities reported more bowel urgency than women in nonmetropolitan communities (33.3% vs 26.8%, P = 0.02); however, prevalence rates between both groups are similar with regards to anal incontinence at least once a month or more (9.2% vs 9.0%, P = 0.76). Prolapse symptoms were also not significantly different between the groups (2.4% in both). There was an increase in prevalence in each of the pelvic floor disorder symptoms with age. Conclusions Pelvic floor disorders are prevalent and increase with age in women in nonmetropolitan communities at rates similar to women in metropolitan communities.

SAGE-Journals-Accessible-Video-Player 10.1089/vid.2013.0018.M1 sj-vid-1-vid-10.1089_vid.2013.0018