Overactive BladderPhase 4NCT03817931
Higher Neural Changes Following Anticholinergic, Beta 3 Agonist, or Placebo in Patients With Overactive Bladder
A Phase 4 study testing Anticholinergic, Beta-3 Agonists, Adrenergic and Functional magnetic resonance imaging (fMRI) in people with Overactive Bladder and Dementia, run by Baylor Research Institute at 2 sites in United States.
Trial summary
Women presenting with overactive bladder symptoms will be randomized to one of 3 arms (anticholinergic, beta-3 agonist, placebo). They will undergo baseline cognitive testing, functional MRI of the brain. Cognitive testing and functional MRI will be repeated after taking their double blinded intervention for 30 days. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder, Dementia, Lower Urinary Tract Symptoms
- What is being tested?
- Anticholinergic, Beta-3 Agonists, Adrenergic and Functional magnetic resonance imaging (fMRI)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Aug 2019to 26 Feb 2022
- Phase
- Phase 4
- 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 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients of age 50 to 90 years old with OAB as defined by the International Continence Society (Urgency with or without urge incontinence, usually with frequency and nocturia in the absence of urinary tract infection or other obvious pathology) who report that symptoms cause moderate problems using the PPBC.
- English-speaking and able to consent
Who cannot join
- Males are excluded to eliminate prostate pathology and urethral strictures, as well as possible bias of gender differences on fMRI.
- Subjects with moderately severe or severe depression (screening score of 15 or more) on the Personal Health Questionnaire-9 (PHQ-9)
- Subjects with moderate to severe anxiety (screening score 25-30) on the Hamilton Anxiety Rating Scale (HAM-A)
- A screening score indicating below normal cognitive function at baseline (score of 25 or less) on the montreal cognitive assessment.
- Subjects with neurologic disorders, dementia, prior cerebrovascular accident, neurogenic bladder or post-void residual greater than 250 mL
- Anticholinergics for OAB or beta 3 agonists use for treatment of OAB in the preceding six months prior to enrollment
- Pregnant or planning to become pregnant in the next six months, or current breastfeeding
- The inability to undergo MRI
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Houston Methodist Hospital
Houston, Texas, 77030
Baylor Scott and White Health
Temple, Texas, 75608
About this study
Official title: Higher Neural and Cognitive Changes Following Anticholinergic Versus Beta 3 Agonist Versus Placebo Treatments in Female Patients With Overactive Bladder: a Multicenter Randomized Controlled Pilot Trial
Women presenting with overactive bladder symptoms will be randomized to one of 3 arms (anticholinergic, beta-3 agonist, placebo). They will undergo baseline cognitive testing, functional MRI of the brain. Cognitive testing and functional MRI will be repeated after taking their double blinded intervention for 30 days.
Read the detailed description
Women presenting to the urology clinic with complaints of urinary urgency, frequency in the absence of urinary tract infection or other obvious pathology will be screened for inclusion/exclusion criteria. Qualifying subjects will be consented.
Baseline health information, bladder symptom questionnaires (Overactive Bladder-questionnaire(OABq), Patient Perception of Bladder Condition (PPBC)), Personal Health Questionnaire-9 (PHQ-9),Hamilton Anxiety Rating Scale (HAM-A), Montreal cognitive assessment (MoCA) will be given. If baseline depression (PHQ-9 score 15 or greater),dementia (MoCA score 25 or less), anxiety (HAM-A score 25-30) are noted the subject is excluded. 15 patients will be recruited from Baylor Scott \& White Health Urology clinic, and 15 patients will be recruited from Houston Methodist Urology clinic.
They will schedule a date within 1 month for the Rey Auditory Verbal Learning Test (RAVLT) and brain functional MRI (fMRI). RAVLT test is performed, followed by resting state fMRI and memory task during fMRI. Vials of medication will be distributed. Vials will be labeled 1-30 and will contain 30 tablets each. The anticholinergic and beta-3 agonist tablets will be encapsulated to look identical to the placebo tablet. Subjects will be reimbursed at this visit. fMRI images at baseline and post-intervention will be analyzed by a radiologist for incidental findings.
One week and two weeks after initiating their tablets, phone interviews will inquire about pill count, side effects, and any new medications. Follow up testing date will be scheduled during the call. The same questions will be repeated at completion of the tablets (30 days after initiation).
At completion of the tablets, subjects return to Houston Methodist for repeat RAVLT and fMRI. Subjects will be reimbursed the other half of their compensation at this visit.
An expert physicist will analyze the BOLD signal intensity and FC pattern in a priori selected regions of interest before and after interventions.
- Being tested
- Anticholinergic, Beta-3 Agonists, Adrenergic, Functional magnetic resonance imaging (fMRI), Rey Auditory Verbal Learning Test (RAVLT)
- Medical subject headings
- Urinary Bladder, Overactive, Dementia, Lower Urinary Tract Symptoms, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnticholinergicDrug
Also called Solifenacin, VESIcare
Tablet taken once daily.
Beta-3 Agonists, AdrenergicDrug
Also called Mirabegron, Myrbetriq
Tablet taken once daily.
Functional magnetic resonance imaging (fMRI)Diagnostic test
All subjects have fMRI at baseline and again after 30 days
Rey Auditory Verbal Learning Test (RAVLT)Diagnostic test
Also called cognitive testing
All subjects have RAVLT at baseline and again after 30 days. RAVLT evaluates: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo pill identical will be identical to tablets in the other 2 arms. Receives: Diagnostic Test: Functional magnetic resonance imaging (fMRI); Diagnostic Test: Rey Auditory Verbal Learning Test (RAVLT) |
| Anticholinergic | Active comparator | Solifenacin 5 mg tablet orally once daily for 30 days Receives: Drug: Anticholinergic; Diagnostic Test: Functional magnetic resonance imaging (fMRI); Diagnostic Test: Rey Auditory Verbal Learning Test (RAVLT) |
| Beta-3 agonists, adrenergic | Active comparator | Mirabegron 25 mg tablet orally once daily for 30 days Receives: Drug: Beta-3 Agonists, Adrenergic; Diagnostic Test: Functional magnetic resonance imaging (fMRI); Diagnostic Test: Rey Auditory Verbal Learning Test (RAVLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional connectivity on MRI
Functional connectivity during a word recognition task will be compared within subjects from baseline and after 29+/- 1 day of intervention medication.
Measured: 29 +/-1 days
Resting state blood oxygenation level dependent (BOLD)changes
During resting state, BOLD changes will be compared within subjects from baseline and after 29+/- 1 day of intervention medication.
Measured: 29 +/-1 days
Diffusion tensor imaging
Fractional anisotropy and mean diffusivity from diffusion tensor images will be compared within subjects from baseline and after 29+/- 1 day of intervention medication.
Measured: 29 +/-1 days
Secondary outcomes (3)
Score on Rey Auditory Verbal Learning Test (RAVLT)
Baseline testing will be compared with post-intervention testing
Measured: 30 days
Overactive bladder questionnaire (OAB-q)
Baseline score of this validated questionnaire will be compared with post-intervention score
Measured: 30 days
Patient Perception of Bladder Condition (PPBC)
Baseline score of this validated questionnaire will be compared with post-intervention score
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start5 Aug 2019
- Primary completion2 Feb 2022
- Study completion26 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Permuted block stratified by recruitment site
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, International Urogynecological Association
- Responsible party
- Sponsor
- Investigators
- Jill Danford, MD, Principal investigator, Baylor Scott and White HealthRose Khavari, MD, Principal investigator, The Methodist Hospital Research InstituteRachel High, DO, Principal investigator, Baylor Scott and White Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817931
- Sponsor's protocol ID
- 160362
- Status last verified
- Aug 2019
- First submitted
- 24 Jan 2019
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan.
Publications
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PubMed 37160401
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Higher Neural and Cognitive Changes Following Anticholinergic Versus Beta 3 Agonist Versus Placebo Treatments in Female Patients With Overactive Bladder: a Multicenter Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT03817931
- Acronym / sponsor ID
- 160362
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, International Urogynecological Association
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 26 Feb 2022 (actual)
- First posted
- 28 Jan 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.
Women presenting with overactive bladder symptoms will be randomized to one of 3 arms (anticholinergic, beta-3 agonist, placebo). They will undergo baseline cognitive testing, functional MRI of the brain. Cognitive testing and functional MRI will be repeated after taking their double blinded intervention for 30 days.
Detailed description
Women presenting to the urology clinic with complaints of urinary urgency, frequency in the absence of urinary tract infection or other obvious pathology will be screened for inclusion/exclusion criteria. Qualifying subjects will be consented.
Baseline health information, bladder symptom questionnaires (Overactive Bladder-questionnaire(OABq), Patient Perception of Bladder Condition (PPBC)), Personal Health Questionnaire-9 (PHQ-9),Hamilton Anxiety Rating Scale (HAM-A), Montreal cognitive assessment (MoCA) will be given. If baseline depression (PHQ-9 score 15 or greater),dementia (MoCA score 25 or less), anxiety (HAM-A score 25-30) are noted the subject is excluded. 15 patients will be recruited from Baylor Scott \& White Health Urology clinic, and 15 patients will be recruited from Houston Methodist Urology clinic.
They will schedule a date within 1 month for the Rey Auditory Verbal Learning Test (RAVLT) and brain functional MRI (fMRI). RAVLT test is performed, followed by resting state fMRI and memory task during fMRI. Vials of medication will be distributed. Vials will be labeled 1-30 and will contain 30 tablets each. The anticholinergic and beta-3 agonist tablets will be encapsulated to look identical to the placebo tablet. Subjects will be reimbursed at this visit. fMRI images at baseline and post-intervention will be analyzed by a radiologist for incidental findings.
One week and two weeks after initiating their tablets, phone interviews will inquire about pill count, side effects, and any new medications. Follow up testing date will be scheduled during the call. The same questions will be repeated at completion of the tablets (30 days after initiation).
At completion of the tablets, subjects return to Houston Methodist for repeat RAVLT and fMRI. Subjects will be reimbursed the other half of their compensation at this visit.
An expert physicist will analyze the BOLD signal intensity and FC pattern in a priori selected regions of interest before and after interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Permuted block stratified by recruitment site
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Diagnostic Test: Functional magnetic resonance imaging (fMRI), Diagnostic Test: Rey Auditory Verbal Learning Test (RAVLT)Placebo pill identical will be identical to tablets in the other 2 arms. |
| Anticholinergic | Active comparator | Drug: Anticholinergic, Diagnostic Test: Functional magnetic resonance imaging (fMRI), Diagnostic Test: Rey Auditory Verbal Learning Test (RAVLT)Solifenacin 5 mg tablet orally once daily for 30 days |
| Beta-3 agonists, adrenergic | Active comparator | Drug: Beta-3 Agonists, Adrenergic, Diagnostic Test: Functional magnetic resonance imaging (fMRI), Diagnostic Test: Rey Auditory Verbal Learning Test (RAVLT)Mirabegron 25 mg tablet orally once daily for 30 days |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients of age 50 to 90 years old with OAB as defined by the International Continence Society (Urgency with or without urge incontinence, usually with frequency and nocturia in the absence of urinary tract infection or other obvious pathology) who report that symptoms cause moderate problems using the PPBC.
- English-speaking and able to consent
Key exclusion criteria (8 listed)
- Males are excluded to eliminate prostate pathology and urethral strictures, as well as possible bias of gender differences on fMRI.
- Subjects with moderately severe or severe depression (screening score of 15 or more) on the Personal Health Questionnaire-9 (PHQ-9)
- Subjects with moderate to severe anxiety (screening score 25-30) on the Hamilton Anxiety Rating Scale (HAM-A)
- A screening score indicating below normal cognitive function at baseline (score of 25 or less) on the montreal cognitive assessment.
- Subjects with neurologic disorders, dementia, prior cerebrovascular accident, neurogenic bladder or post-void residual greater than 250 mL
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 |
|---|---|---|
| AnticholinergicAlso: Solifenacin, VESIcareTablet taken once daily. | Drug | Anticholinergic |
| Beta-3 Agonists, AdrenergicAlso: Mirabegron, MyrbetriqTablet taken once daily. | Drug | Beta-3 agonists, adrenergic |
| Functional magnetic resonance imaging (fMRI)All subjects have fMRI at baseline and again after 30 days | Diagnostic test | Anticholinergic, Beta-3 agonists, adrenergic, Placebo |
| Rey Auditory Verbal Learning Test (RAVLT)Also: cognitive testingAll subjects have RAVLT at baseline and again after 30 days. RAVLT evaluates: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. | Diagnostic test | Anticholinergic, Beta-3 agonists, adrenergic, Placebo |
Primary outcome
Functional connectivity on MRI
Time frame: 29 +/-1 days
Functional connectivity during a word recognition task will be compared within subjects from baseline and after 29+/- 1 day of intervention medication.
Resting state blood oxygenation level dependent (BOLD)changes
Time frame: 29 +/-1 days
During resting state, BOLD changes will be compared within subjects from baseline and after 29+/- 1 day of intervention medication.
Diffusion tensor imaging
Time frame: 29 +/-1 days
Fractional anisotropy and mean diffusivity from diffusion tensor images will be compared within subjects from baseline and after 29+/- 1 day of intervention medication.
3 secondary outcomes
Score on Rey Auditory Verbal Learning Test (RAVLT)
Time frame: 30 days
Overactive bladder questionnaire (OAB-q)
Time frame: 30 days
Patient Perception of Bladder Condition (PPBC)
Time frame: 30 days
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 2 Feb 2024.
- Derived from this study: PubMed 37160401Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
- Individual participant dataSharing planned: No. There is not a plan.
Related trials for Overactive Bladder
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Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
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.
Jill Danford, MD principal investigator
Baylor Scott and White Health
Rose Khavari, MD principal investigator
The Methodist Hospital Research Institute
Rachel High, DO principal investigator
Baylor Scott and White Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anticholinergic, Beta-3 Agonists, Adrenergic and Functional magnetic resonance imaging (fMRI) in people with Overactive Bladder and Dementia, run by Baylor Research Institute 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 2 inclusion and 8 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 2 Feb 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Functional connectivity on MRI (time frame: 29 +/-1 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03817931, which also lists 1 linked publication.
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 2 Feb 2024.