Optimizing Overactive Bladder Treatment: A Randomized Trial Investigating the Influence of Probiotic Therapy on the Urinary Microbiome and Response to Anticholinergic or Beta-3 Agonist Therapy
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Overactive Bladder
- 发起方
- University of North Carolina, Chapel Hill
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Number of Participants with Treatment Success Based on the PGI-I Validated Questionnaire Response
- 状态
- 已完成
- 最后更新
- 5年前
概览
简要总结
Purpose: This is a pilot randomized double-blind placebo controlled trial of anticholinergic or beta-3 agonist medication with or without concomitant probiotic therapy in women initiating medication therapy for overactive bladder (OAB). The aims of this study are to:
- Explore how concomitant probiotic therapy influences response to medication for OAB in a randomized controlled trial
- Investigate whether 4 weeks of probiotic therapy alters the urinary microbiome
- Assess for predictors of response to therapy
Participants: Women 18 years of age or older presenting to the Division of Urogynecology and Reconstructive Pelvic Surgery clinic with OAB/UUI or UUI-predominant mixed incontinence who desire nonsurgical therapy will be eligible for participation.
Procedures (methods): The study will be conducted over a two-year time frame and the primary outcome will be subjective improvement in symptoms as assessed by the Patient Global Impression of Improvement (PGI-I) validated questionnaire at 4 weeks after initiating anticholinergic or beta-3 agonist medication and study drug. The study aims to recruit up to 140 participants randomized in a 1:1 ratio to either concomitant probiotic or placebo medication.
详细描述
Overactive bladder (OAB) is a highly prevalent condition that negatively impacts the lives of millions of adults in the United States. Anticholinergic and beta-3 agonist medications are commonly used to treat OAB but compliance is low due to variable efficacy and bothersome side effects. The existence of a urinary microbiome was recently discovered and early investigations have revealed that lower Lactobacillus load is correlated with the presence of OAB symptoms and a poorer response to anticholinergic therapy. This proposed pilot study is a randomized double-blind placebo-controlled trial (RCT) of concomitant probiotic therapy in women initiating medication therapy for OAB to explore how probiotics influence response to anticholinergic and beta-3 agonist medications, investigate whether probiotic therapy alters the urinary microbiome, and assess for predictors of response to therapy. Primary Aim: To explore how concomitant probiotic therapy influences response to medication for OAB in a RCT Secondary Aims: 1. To investigate whether 4 weeks of probiotic therapy alters the urinary microbiome. 2. To assess for predictors of response to therapy
研究者
入排标准
入选标准
- •Women age ≥ 18 years
- •English-speaking
- •OAB/UUI or urge-predominant mixed incontinence per the Medical Epidemiologic and Social Aspects of Aging (MESA) questionnaire
排除标准
- •Neurogenic bladder or urinary retention (postvoid residual (PVR) \>150 mL)
- •Probiotic use within the past 4 weeks
- •Inflammatory bowel disease or history of bariatric surgery
- •Pelvic organ prolapse past the hymen
- •Current symptomatic UTI or systemic antibiotic exposure within 4 weeks
- •Current treatment for recurrent UTI or history of recurrent UTI in the last 6 months
- •Immunosuppressive therapy (i.e., prednisone or chemotherapy)
- •Contraindication to anticholinergic or beta-3 agonist medication (including pregnancy)
- •Prior neuromodulation therapy for OAB
- •Inability or unwillingness to comply with study protocol
结局指标
主要结局
Number of Participants with Treatment Success Based on the PGI-I Validated Questionnaire Response
时间窗: 4 weeks
Treatment success at 4 weeks after initiation of anticholinergic of beta-3 agonist therapy. Treatment success will be defined as a response of "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I), which is a single item questionnaire that asks respondents to rate their improvement after undergoing treatment on a 7-point Likert scale ranging from "very much worse" to "very much better." Statistical analysis will be by intention-to-treat for the primary outcome. A chi-square test will be utilized to determine if there is a statistically significant difference between the two cohorts and sensitivity analyses will be performed using logistic regression analysis.
次要结局
- Change in participant's urinary microbiome from baseline to week 4(Baseline, Week 4)
- Urinary microbiome Lactobacillus correlation with treatment success as defined by PGI-I Validated Questionnaire Response(4 weeks)
- OAB-Q SF Change Score(Baseline, Week 4)
- TQSM-II Validated Questionnaire Score(Week 4 Visit)
- Correlation between race/ethnicity and treatment success as Defined by PGI-I Validated Questionnaire Response(Week 4 Visit)
- Correlation between OAB medication dose and Lactobacillus Load in the Urinary Microbiome(Week 4)