Higher Neural Changes Following Anticholinergic, Beta 3 Agonist, or Placebo in Patients With Overactive Bladder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-05

Study Completion Date

2022-02-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Anticholinergics on Cognitive Function in the Elderly

NCT01922115

Mental Competency Urinary Bladder, Overactive Cognitive Function

COMPLETED PHASE4

Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease

NCT00892450

Parkinson's Disease Overactive Bladder

COMPLETED NA

Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

NCT00196404

Urinary Incontinence

COMPLETED PHASE2

Effects of Rec 0/0438 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury

NCT03482037

Neurogenic Detrusor Overactivity

COMPLETED PHASE1/PHASE2

Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers

NCT00752141

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overactive Bladder Dementia Lower Urinary Tract Symptoms Incontinence, Urge

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Permuted block stratified by recruitment site

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Randomization using a random number system will be performed by the compounding pharmacy. Records linking subject number to their allocation will be kept by the pharmacy, inaccessible to the investigator, patient, care providers.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Placebo pill identical will be identical to tablets in the other 2 arms.

Group Type PLACEBO_COMPARATOR

Functional magnetic resonance imaging (fMRI)

Intervention Type DIAGNOSTIC_TEST

All subjects have fMRI at baseline and again after 30 days

Rey Auditory Verbal Learning Test (RAVLT)

Intervention Type DIAGNOSTIC_TEST

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.

Anticholinergic

Solifenacin 5 mg tablet orally once daily for 30 days

Group Type ACTIVE_COMPARATOR

Anticholinergic

Intervention Type DRUG

Tablet taken once daily.

Functional magnetic resonance imaging (fMRI)

Intervention Type DIAGNOSTIC_TEST

All subjects have fMRI at baseline and again after 30 days

Rey Auditory Verbal Learning Test (RAVLT)

Intervention Type DIAGNOSTIC_TEST

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.

Beta-3 agonists, adrenergic

Mirabegron 25 mg tablet orally once daily for 30 days

Group Type ACTIVE_COMPARATOR

Beta-3 Agonists, Adrenergic

Intervention Type DRUG

Tablet taken once daily.

Functional magnetic resonance imaging (fMRI)

Intervention Type DIAGNOSTIC_TEST

All subjects have fMRI at baseline and again after 30 days

Rey Auditory Verbal Learning Test (RAVLT)

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anticholinergic

Tablet taken once daily.

Intervention Type DRUG

Beta-3 Agonists, Adrenergic

Tablet taken once daily.

Intervention Type DRUG

Functional magnetic resonance imaging (fMRI)

All subjects have fMRI at baseline and again after 30 days

Intervention Type DIAGNOSTIC_TEST

Rey Auditory Verbal Learning Test (RAVLT)

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Solifenacin VESIcare Mirabegron Myrbetriq cognitive testing

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes