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Optimizing Overactive Bladder Treatment

NCT03904407 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-05-11

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Alexis Dieter, MD · The University of North Carolina at Chapel Hill School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2020-05-01
Completion
2020-05-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03904407 on ClinicalTrials.gov