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NCT03904407 · ClinicalTrials.gov registry record · NA
Optimizing Overactive Bladder Treatment
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
NCT03904407 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 29 participants.
The verdict
NCT03904407, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
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.
Interventions
- OTHER Lactobacillus Probiotic Capsule
- OTHER Matching Lactobacillus Probiotic Placebo Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2020-05-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03904407
The ClinicalTrials.gov registry entry for NCT03904407 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lactobacillus Probiotic Capsule is the first listed.
NCT03904407 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03904407 about?
NCT03904407 is a clinical study titled "Optimizing Overactive Bladder Treatment". 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 prob...
What is the current status of trial NCT03904407?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2019-06-01. Estimated completion is 2020-05-01.
What interventions are being tested in trial NCT03904407?
The interventions under investigation include: Lactobacillus Probiotic Capsule (OTHER), Matching Lactobacillus Probiotic Placebo Capsule (OTHER).
Who is sponsoring clinical trial NCT03904407?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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