Clinical trial NCT03904407: Optimizing Overactive Bladder Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: overactive bladder
probiotic
anticholinergic
beta-3 agonist
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
First posted: 2019-04-05
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double blind placebo controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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:

1. To investigate whether 4 weeks of probiotic therapy alters the urinary microbiome.
2. To assess for predictors of response to therapy

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Treatment Success Based on the PGI-I Validated Questionnaire Response
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in participant's urinary microbiome from baseline to week 4
timeFrame: Baseline, Week 4
measure: Urinary microbiome Lactobacillus correlation with treatment success as defined by PGI-I Validated Questionnaire Response
timeFrame: 4 weeks
measure: OAB-Q SF Change Score
timeFrame: Baseline, Week 4
measure: TQSM-II Validated Questionnaire Score
timeFrame: Week 4 Visit
measure: Correlation between race/ethnicity and treatment success as Defined by PGI-I Validated Questionnaire Response
timeFrame: Week 4 Visit
measure: Correlation between OAB medication dose and Lactobacillus Load in the Urinary Microbiome
timeFrame: Week 4
Other outcomes:
measure: Per Protocol Analysis of Treatment Success as Defined by PGI-I Validated Questionnaire Response
timeFrame: Week 4
Locations:
city: Hillsborough
country: United States
facility: UNC Hillsborough Medical Office Building
state: North Carolina
city: Raleigh
country: United States
facility: UNC Urogynecology and Reconstructive Pelvic Surgery
state: North Carolina
Study officials:
affiliation: The University of North Carolina at Chapel Hill School of Medicine
name: Alexis Dieter, MD
role: PRINCIPAL_INVESTIGATOR
References: