NCT03904407

Optimizing Overactive Bladder Treatment

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: 1. Explore how concomitant probiotic therapy influences response to medication for OAB in a randomized controlled trial 2. Investigate whether 4 weeks of probiotic therapy alters the urinary microbiome 3. 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.

Detailed description

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

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
OTHER	Lactobacillus Probiotic Capsule	One over-the-counter, probiotic capsule taken by mouth once daily for 4 weeks. Each capsule contains 10 billion cells comprised of: * Lactobacillus crispatus LbV 88 * Lactobacillus jensenii LbV 116 * Lactobacillus gasseri LbV 150N * Lactobacillus rhamnosus LbV 96
OTHER	Matching Lactobacillus Probiotic Placebo Capsule	Lactobacillus Probiotic placebo capsules identical in appearance taken by mouth once daily for 4 weeks

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2019-04-05
• Last updated: 2020-05-11

Locations

2 sites across 1 country: United States