Status:
COMPLETED
Higher Neural Changes Following Anticholinergic, Beta 3 Agonist, or Placebo in Patients With Overactive Bladder
Lead Sponsor:
Baylor Research Institute
Collaborating Sponsors:
The Methodist Hospital Research Institute
International Urogynecological Association
Conditions:
Overactive Bladder
Dementia
Eligibility:
FEMALE
18-90 years
Phase:
PHASE4
Brief 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 br...
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 crite...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03817931
Start Date
August 5 2019
End Date
February 26 2022
Last Update
February 2 2024
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Baylor Scott and White Health
Temple, Texas, United States, 75608