Using rTMS to treat overactive bladder
Higher Neural and Clinical Effects of Non-Invasive Transcranial Neuromodulation in Adults With Overactive Bladder
NA · The Methodist Hospital Research Institute · NCT06198439
This study is testing whether a new non-invasive treatment using brain stimulation can help adults with overactive bladder feel better and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06198439 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of repetitive transcranial magnetic stimulation (rTMS) as a non-invasive treatment for overactive bladder (OAB) symptoms. Eligible adults aged 40 to 80 with OAB will undergo a baseline evaluation, including questionnaires and fMRI to assess brain activity related to urinary urgency. Participants will receive five daily sessions of rTMS targeting specific brain regions, followed by a repeat evaluation to measure changes in symptoms and brain activity. The study aims to explore the safety and efficacy of rTMS in improving quality of life for individuals suffering from OAB.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 40 to 80 who have experienced overactive bladder symptoms for at least three months without an active urinary tract infection.
Not a fit: Patients with contraindications to MRI, a history of seizure disorders, or certain neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from overactive bladder by reducing symptoms and associated mental health burdens.
How similar studies have performed: Previous studies have shown promising results for rTMS in treating various neurological conditions, suggesting potential for success in this novel application for overactive bladder.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Houston, Texas
- Houston Methodist Hospital — Houston, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Michelle Almarez, BBA
- Email: almarez@houstonmethodist.org
- Phone: 713-441-5920
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Overactive Bladder, Overactive Bladder Syndrome, Urge Incontinence, Urgency-frequency Syndrome, Urinary Incontinence, Urinary Incontinence, Urge