Optimizing Overactive Bladder Treatment
Public ClinicalTrials.gov record NCT03904407. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03904407
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 29 participants
Conditions and interventions
Conditions
Interventions
Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2019
- Primary completion
- Apr 30, 2020
- Completion
- Apr 30, 2020
- Last update posted
- May 10, 2020
2019 – 2020
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UNC Hillsborough Medical Office Building | Hillsborough | North Carolina | 27278 | — |
| UNC Urogynecology and Reconstructive Pelvic Surgery | Raleigh | North Carolina | 27607 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03904407, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 10, 2020 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03904407 live on ClinicalTrials.gov.