Optimizing Overactive Bladder Treatment

NCT ID: NCT03904407

Last Updated: 2020-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-05-01

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

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic

Lactobacillus probiotic capsules in addition to a routine-care prescribed anticholinergic or beta-3 agonist medication for 4 weeks.

Group Type: EXPERIMENTAL

Lactobacillus Probiotic Capsule

Intervention Type: OTHER

One over-the-counter, probiotic capsule taken by mouth once daily for 4 weeks. Each capsule contains 10 billion cells comprised of:

• Lactobacillus crispatus LbV 88
• Lactobacillus jensenii LbV 116
• Lactobacillus gasseri LbV 150N
• Lactobacillus rhamnosus LbV 96

Placebo

Matching Lactobacillus probiotic placebo capsules in addition to a routine-care prescribed anticholinergic or beta-3 agonist medication for 4 weeks.

Group Type: PLACEBO_COMPARATOR

Matching Lactobacillus Probiotic Placebo Capsule

Intervention Type: OTHER

Lactobacillus Probiotic placebo capsules identical in appearance taken by mouth once daily for 4 weeks

Interventions

Lactobacillus Probiotic Capsule

One over-the-counter, probiotic capsule taken by mouth once daily for 4 weeks. Each capsule contains 10 billion cells comprised of:

• Lactobacillus crispatus LbV 88
• Lactobacillus jensenii LbV 116
• Lactobacillus gasseri LbV 150N
• Lactobacillus rhamnosus LbV 96

Intervention Type: OTHER

Matching Lactobacillus Probiotic Placebo Capsule

Lactobacillus Probiotic placebo capsules identical in appearance taken by mouth once daily for 4 weeks

Intervention Type: OTHER

Other Intervention Names

Jarro-Dophilus Women; Sugar pill

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexis Dieter, MD

Role: PRINCIPAL_INVESTIGATOR

The University of North Carolina at Chapel Hill School of Medicine

Locations

UNC Hillsborough Medical Office Building

Hillsborough, North Carolina, United States

UNC Urogynecology and Reconstructive Pelvic Surgery

Raleigh, North Carolina, United States

Countries

United States

Other Identifiers

18-0030

Identifier Type: -

Identifier Source: org_study_id