Overactive BladderOPSNCT03904407
Optimizing Overactive Bladder Treatment
A study testing Lactobacillus Probiotic Capsule in people with Overactive Bladder, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Lactobacillus Probiotic Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age ≥ 18 years
- English-speaking
- OAB/UUI or urge-predominant mixed incontinence per the Medical Epidemiologic and Social Aspects of Aging (MESA) questionnaire
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
UNC Hillsborough Medical Office Building
Hillsborough, North Carolina, 27278
UNC Urogynecology and Reconstructive Pelvic Surgery
Raleigh, North Carolina, 27607
About this study
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
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
Read more
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.
Read the 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:
- To investigate whether 4 weeks of probiotic therapy alters the urinary microbiome.
- To assess for predictors of response to therapy
- Conditions
- Overactive Bladder
- Being tested
- Lactobacillus Probiotic Capsule, Matching Lactobacillus Probiotic Placebo Capsule
- Keywords
- overactive bladder, probiotic, anticholinergic, beta-3 agonist
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus Probiotic CapsuleOther
Also called Jarro-Dophilus Women
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
Matching Lactobacillus Probiotic Placebo CapsuleOther
Also called Sugar pill
Lactobacillus Probiotic placebo capsules identical in appearance taken by mouth once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Lactobacillus probiotic capsules in addition to a routine-care prescribed anticholinergic or beta-3 agonist medication for 4 weeks. Receives: 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. Receives: Other: Matching Lactobacillus Probiotic Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (6)
Change in participant's urinary microbiome from baseline to 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.
Measured: Baseline, Week 4
Urinary microbiome Lactobacillus correlation with treatment success as defined by PGI-I Validated Questionnaire Response
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).
Measured: 4 weeks
OAB-Q SF Change Score
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.
Measured: Baseline, Week 4
TQSM-II Validated Questionnaire Score
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.
Measured: Week 4 Visit
Correlation between race/ethnicity and treatment success as Defined by PGI-I Validated Questionnaire Response
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.
Measured: Week 4 Visit
Correlation between OAB medication dose and Lactobacillus Load in the Urinary Microbiome
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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Jun 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blind placebo controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
- Responsible party
- Sponsor
- Investigators
- Alexis Dieter, MD, Principal investigator, The University of North Carolina at Chapel Hill School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904407
- Sponsor's protocol ID
- 18-0030
- Acronym
- OPS
- Status last verified
- May 2020
- First submitted
- 3 Apr 2019
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03904407
- Acronym / sponsor ID
- OPS / 18-0030
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, probiotic, anticholinergic, beta-3 agonist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To investigate whether 4 weeks of probiotic therapy alters the urinary microbiome.
- To assess for predictors of response to therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double blind placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Other: Lactobacillus Probiotic CapsuleLactobacillus probiotic capsules in addition to a routine-care prescribed anticholinergic or beta-3 agonist medication for 4 weeks. |
| Placebo | Placebo comparator | Other: Matching Lactobacillus Probiotic Placebo CapsuleMatching Lactobacillus probiotic placebo capsules in addition to a routine-care prescribed anticholinergic or beta-3 agonist medication for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women age ≥ 18 years
- English-speaking
- OAB/UUI or urge-predominant mixed incontinence per the Medical Epidemiologic and Social Aspects of Aging (MESA) questionnaire
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus Probiotic CapsuleAlso: Jarro-Dophilus WomenOne 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 | Probiotic |
| Matching Lactobacillus Probiotic Placebo CapsuleAlso: Sugar pillLactobacillus Probiotic placebo capsules identical in appearance taken by mouth once daily for 4 weeks | Other | Placebo |
Primary outcome
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.
6 secondary outcomes
Change in participant's urinary microbiome from baseline to week 4
Time frame: Baseline, Week 4
Urinary microbiome Lactobacillus correlation with treatment success as defined by PGI-I Validated Questionnaire Response
Time frame: 4 weeks
OAB-Q SF Change Score
Time frame: Baseline, Week 4
TQSM-II Validated Questionnaire Score
Time frame: Week 4 Visit
Correlation between race/ethnicity and treatment success as Defined by PGI-I Validated Questionnaire Response
Time frame: Week 4 Visit
Correlation between OAB medication dose and Lactobacillus Load in the Urinary Microbiome
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Dieter, MD principal investigator
The University of North Carolina at Chapel Hill School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus Probiotic Capsule in people with Overactive Bladder, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Success Based on the PGI-I Validated Questionnaire Response (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.