Status:
RECRUITING
rTMS in Overactive Bladder
Lead Sponsor:
The Methodist Hospital Research Institute
Conditions:
Overactive Bladder
Overactive Bladder Syndrome
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
Overactive bladder (OAB) imposes a significant quality of life, mental health, and economic burdens. OAB with or without Urgency incontinence is associated with depression, sexual dysfunction, and lim...
Detailed Description
This prospective trial will enroll eligible adults with OAB recruited from Urology and urogynecology clinics. Subjects have a baseline evaluation with questionnaires, clinical data, and fMRI to assess...
Eligibility Criteria
Inclusion
- Females \& Males
- 40 to 80 years old
- 3 months of OAB symptoms without active urinary tract infection currently
- Bladder diary:
- Mean voids/24 hours ≥ 8.0
- Mean urgency episodes/24 hours ≥ 3.0
- Montreal Cognitive Assessment (MoCA) score \>10
Exclusion
- Pregnant, nursing, or self-report of planning to become pregnant.
- Contraindication to MRI or to the Rapid2 Magstim Device as listed in the operator manual
- Qmax \< 10 ml/s in males on uroflow
- \< 20th percentile on Liverpool nomogram
- Postvoid residual volume ≥ 200 mL, suprapubic or indwelling catheter
- Personal or immediate family history of seizure disorder
- Taking (bupropion) Wellbutrin or heavy alcohol use
- Parkinson's disease, Multiple sclerosis, spinal cord injury
- Intracranial lesions and hemorrhagic stroke within the last 12 months
- History of interstitial cystitis, pelvic radiation, bladder augmentation
- Intradetrusor botulinum toxin injections within 6 months
- Pelvic floor therapy within 2 months.
- Active/on-mode Sacral nerve stimulator (eligible if turned off)
- Incarcerated patients
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06198439
Start Date
January 8 2024
End Date
July 1 2026
Last Update
February 13 2025
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030