Optimizing Overactive Bladder Treatment (OPS)
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Details and patient eligibility
About
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:
- Explore how concomitant probiotic therapy influences response to medication for OAB in a randomized controlled trial
- Investigate whether 4 weeks of probiotic therapy alters the urinary microbiome
- 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.
Full 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:
- To investigate whether 4 weeks of probiotic therapy alters the urinary microbiome.
- To assess for predictors of response to therapy
Enrollment
Sex
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Volunteers
Inclusion criteria
- Women age ≥ 18 years
- English-speaking
- OAB/UUI or urge-predominant mixed incontinence per the Medical Epidemiologic and Social Aspects of Aging (MESA) questionnaire
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
29 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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