Optimizing Overactive Bladder Treatment

NCT03904407 | Completed

• 1 other identifier: 18-0030
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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. 1.Explore how concomitant probiotic therapy influences response to medication for OAB in a randomized controlled trial
2. 2.Investigate whether 4 weeks of probiotic therapy alters the urinary microbiome
3. 3.Assess for predictors of response to therapy

Conditions

Overactive Bladder

Keywords

overactive bladder; probiotic; anticholinergic; beta-3 agonist

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment Success Based on the PGI-I Validated Questionnaire Response

  Treatment success at 4 weeks after initiation of anticholinergic of beta-3 agonist therapy. Treatment success will be defined as a response of "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I), which is a single item questionnaire that asks respondents to rate their improvement after undergoing treatment on a 7-point Likert scale ranging from "very much worse" to "very much better." Statistical analysis will be by intention-to-treat for the primary outcome. A chi-square test will be utilized to determine if there is a statistically significant difference between the two cohorts and sensitivity analyses will be performed using logistic regression analysis.

  4 weeks

Secondary Outcomes (6)

• Change in participant's urinary microbiome from baseline to week 4

  Baseline, Week 4

• Urinary microbiome Lactobacillus correlation with treatment success as defined by PGI-I Validated Questionnaire Response

  4 weeks

• OAB-Q SF Change Score

  Baseline, Week 4

• TQSM-II Validated Questionnaire Score

  Week 4 Visit

• Correlation between race/ethnicity and treatment success as Defined by PGI-I Validated Questionnaire Response

  Week 4 Visit

Other Outcomes (1)

• Per Protocol Analysis of Treatment Success as Defined by PGI-I Validated Questionnaire Response

  Week 4

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Other: Lactobacillus Probiotic Capsule

Placebo

PLACEBO COMPARATOR

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

Other: Matching Lactobacillus Probiotic Placebo Capsule

Interventions

Lactobacillus Probiotic Capsule 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

Also known as: Jarro-Dophilus Women

Probiotic

Matching Lactobacillus Probiotic Placebo Capsule OTHER

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

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction: collaborator

Study Sites (2)

UNC Hillsborough Medical Office Building

Hillsborough, North Carolina, 27278, United States

Location

UNC Urogynecology and Reconstructive Pelvic Surgery

Raleigh, North Carolina, 27607, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Sugars

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Alexis Dieter, MD

  The University of North Carolina at Chapel Hill School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Probiotic study drug and identical appearing placebo tablet
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double blind placebo controlled trial

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 5, 2019
• Study Start: June 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Until 24 months following publication of the first manuscript from this study.
• Access Criteria: The investigator who proposes to use the data has to have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Locations

US (2)