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Optimizing Overactive Bladder Treatment (OPS)

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ClinicalTrials.gov Identifier: NCT03904407
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : June 20, 2019
Sponsor:
Collaborator:
Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.


Condition or disease Intervention/treatment Phase
Overactive Bladder Other: Lactobacillus Probiotic Capsule Other: Matching Lactobacillus Probiotic Placebo Capsule Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double blind placebo controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Probiotic study drug and identical appearing placebo tablet
Primary Purpose: 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
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probiotic
Lactobacillus probiotic capsules in addition to a routine-care prescribed anticholinergic or beta-3 agonist medication for 4 weeks.
Other: 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
Other Name: Jarro-Dophilus Women

Placebo Comparator: Placebo
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
Lactobacillus Probiotic placebo capsules identical in appearance taken by mouth once daily for 4 weeks
Other Name: Sugar pill




Primary Outcome Measures :
  1. Number of Participants with Treatment Success Based on the PGI-I Validated Questionnaire Response [ Time Frame: 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in participant's urinary microbiome from baseline to week 4 [ Time Frame: Baseline, Week 4 ]
    Each participants' urinary microbiome composition will be analyzed at baseline and at week 4 to determine changes in the microbiome that occur over the study period. The correlation between changes in the urinary microbiome over 4 weeks and study drug allocation (probiotic vs placebo) will be assessed via Chi-square testing.

  2. Urinary microbiome Lactobacillus correlation with treatment success as defined by PGI-I Validated Questionnaire Response [ Time Frame: 4 weeks ]
    The correlation between the presence of Lactobacillus in the urine at baseline and treatment success at week 4 will be analyzed via Chi-Square testing to assess for predictors of response to therapy in women (i.e. treatment success or lack of treatment success based on the primary outcome definition of treatment success as above).

  3. OAB-Q SF Change Score [ Time Frame: Baseline, Week 4 ]
    Individual participant change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between the two cohorts by student's t-test. The OAB-q SF is utilized to assess the impact of OAB symptoms on the patient's life, and has been shown to be responsive to reductions in urinary urgency, frequency and incontinence during anticholinergic therapy. The OAB-q SF questionnaire consists of 19 items divided into a 6-item symptom severity (SS) scale and a 13-item health-related quality of life (HRQL) scale, with both scales ranging from 0 to 100. For the OAB-q SS scale a higher score indicates worse symptom severity while for the OAB-q HRQL scale a higher score indicates better quality of life.

  4. TQSM-II Validated Questionnaire Score [ Time Frame: Week 4 Visit ]
    Treatment Satisfaction Questionnaire for Medication version 2 (TQSM-II) score, the TQSM-II is comprised of 12 questions assessing treatment satisfaction with medication intended for use with a wide variety of medications and illness conditions that specifically assesses the three most common dimensions on which patients evaluate their medication: effectiveness, side effects of use, and convenience of use. TSQM Scale scores range from 0 to 100 with a higher score indicating better satisfaction with treatment. The TQSM-II score at the week 4 visit will be compared between the two cohorts by student's t-test.

  5. Correlation between race/ethnicity and treatment success as Defined by PGI-I Validated Questionnaire Response [ Time Frame: Week 4 Visit ]
    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." The correlation between race/ethnicity and treatment response will be analyzed using chi-square or fisher's exact test.

  6. Correlation between OAB medication dose and Lactobacillus Load in the Urinary Microbiome [ Time Frame: Week 4 ]
    The correlation between the presence of Lactobacillus in the urinary microbiome and dose of OAB medication at 4 weeks (i.e. low dose vs high dose) will be analyzed via Chi-square or fishers exact test.


Other Outcome Measures:
  1. Per Protocol Analysis of Treatment Success as Defined by PGI-I Validated Questionnaire Response [ Time Frame: Week 4 ]
    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." A per protocol analysis of treatment success at 4 weeks (the primary outcome) will also be performed using a chi-square test to determine if there is a statistically significant difference between the two cohorts in treatment success and sensitivity analyses may be performed using logistic regression analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904407


Contacts
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Contact: Alexis Dieter, MD 919-966-4717 alexis_dieter@mned.unc.edu
Contact: Katherine Feliciano, BS 919-966-4717 katherine_feliciano@med.unc.edu

Locations
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United States, North Carolina
UNC Hillsborough Medical Office Building Recruiting
Hillsborough, North Carolina, United States, 27278
Contact: Katerhine Feliciano         
UNC Urogynecology and Reconstructive Pelvic Surgery Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Katherine Feliciano         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction
Investigators
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Principal Investigator: Alexis Dieter, MD The University of North Carolina at Chapel Hill School of Medicine

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03904407     History of Changes
Other Study ID Numbers: 18-0030
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared until 24 months following publication of the first manuscript from this study provided the investigator who proposes to use the data has 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.
Supporting Materials: Study Protocol
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
overactive bladder
probiotic
anticholinergic
beta-3 agonist

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs