Higher Neural Changes Following Anticholinergic, Beta 3 Agonist, or Placebo in Patients With Overactive Bladder
Condition: Overactive Bladder; Dementia; Lower Urinary Tract Symptoms; Incontinence, Urge
MeSH terms: Urinary Bladder, Overactive; Urinary Incontinence, Urge; Lower Urinary Tract Symptoms
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Anticholinergic; Beta-3 Agonists, Adrenergic; Functional magnetic resonance imaging (fMRI); Rey Auditory Verbal Learning Test (RAVLT)
Intervention type(s): Drug; Drug; Diagnostic Test; Diagnostic Test
Intervention description(s): Tablet taken once daily.; Tablet taken once daily.; All subjects have fMRI at baseline and again after 30 days; 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.
Other intervention name(s): Solifenacin; VESIcare; Mirabegron; Myrbetriq; cognitive testing
Intervention MeSH terms: Mirabegron; Solifenacin Succinate; Adrenergic beta-3 Receptor Agonists; Adrenergic Agents; Adrenergic Agonists; Cholinergic Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Permuted block stratified by recruitment site
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention