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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
研究概览
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:
- To investigate whether 4 weeks of probiotic therapy alters the urinary microbiome.
- To assess for predictors of response to therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Probiotic study drug and identical appearing placebo tablet
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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
研究组 & 干预措施
Probiotic
Lactobacillus probiotic capsules in addition to a routine-care prescribed anticholinergic or beta-3 agonist medication for 4 weeks.
干预措施: Lactobacillus Probiotic Capsule (Other)
Placebo
Matching Lactobacillus probiotic placebo capsules in addition to a routine-care prescribed anticholinergic or beta-3 agonist medication for 4 weeks.
干预措施: Matching Lactobacillus Probiotic Placebo Capsule (Other)
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)