Optimizing Overactive Bladder Treatment

Completed · Not applicable · Has a placebo group

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT03904407

Run by

University of North Carolina, Chapel Hill

People needed

29

Starts

2019-06-01

Expected to finish

2020-05-01

Last updated by the study team

2020-05-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women age ≥ 18 years
• English-speaking
• OAB/UUI or urge-predominant mixed incontinence per the Medical Epidemiologic and Social Aspects of Aging (MESA) questionnaire

You may not qualify if…

• 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

Where it is running

• UNC Hillsborough Medical Office Building — Hillsborough, North Carolina, United States
• UNC Urogynecology and Reconstructive Pelvic Surgery — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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