rTMS in Overactive Bladder (TMS_OAB)

March 23, 2026 updated by: The Methodist Hospital Research Institute

Higher Neural and Clinical Effects of Non-Invasive Transcranial Neuromodulation in Adults With Overactive Bladder

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 limitation of social interactions and physical activities, which significantly affects quality of life.

Non-invasive neuromodulation with repetitive transcranial magnetic stimulation (rTMS) can be used in research settings to investigate responses to focal regional brain activation. In the clinical setting, rTMS normalizes brain activity with associated clinical benefits in conditions such as refractory depression. rTMS has been studied for effects on lower urinary tract symptoms (LUTS) in bladder pain and neurogenic lower urinary tract symptoms (LUTS) populations.

Unlike many standard of care OAB interventions, the safety of rTMS is well-reported, including for use in elderly populations and those with cognitive impairment. Functional magnetic resonance imaging (fMRI) to evaluate neuroplasticity is emerging as an essential tool to define OAB phenotypes; however, phenotyping studies guided by mechanistic data are lacking. The effects of central neuromodulation on regions involved OAB mechanisms and associated physiological and clinical responses are unknown. This study will be the first to report neuroplasticity, physiologic, and clinical effects of central neuromodulation with rTMS in adults with OAB.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 brain activity during urinary urgency. All subjects receive the intervention: 5 daily sessions of rTMS to regions of interest. Electromyography will assess pelvic floor muscle activity at rest during rTMS. Following the intervention, an evaluation with questionnaires, clinical data, and fMRI is repeated.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial magnetic stimulation
All study subjects undergo five sessions of rTMS. The 40-minute sessions target the supplemental motor area (inhibitory stimulation) and prefrontal cortex (excitatory stimulation)
Device: Transcranial Magnetic Stimulation
Magstim Rapid2 Therapy System
Other Names:
  • Magstim Rapid2 Therapy System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional brain activity
Time Frame: Post-intervention at: 0 to 3 days
Activity in the supplemental motor area and prefrontal cortex during full bladder
Post-intervention at: 0 to 3 days
Functional connectivity
Time Frame: Post-intervention at: 0 to 3 days
Connectivity of regions of interest with a full bladder and empty bladder state
Post-intervention at: 0 to 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic floor muscle activity
Time Frame: on day 5 of the intervention
Surface electromyography of the pelvic floor muscles during rTMS sessions with subjects at rest
on day 5 of the intervention
Urinary frequency
Time Frame: Post-intervention at: 1 day, 3 weeks, 6 weeks
Mean Voids per 24 hours (n) 2- day bladder diary (higher score is worse outcome)
Post-intervention at: 1 day, 3 weeks, 6 weeks
Urgency episodes
Time Frame: Post-intervention at: 1 day, 3 weeks, 6 weeks
Mean urgency episodes per 24 hours (n) 2- day bladder diary (higher score is worse outcome)
Post-intervention at: 1 day, 3 weeks, 6 weeks
OAB Symptom Bother
Time Frame: Post-intervention at: 1 day, 3 weeks, 6 weeks
OAB-q symptom burden score (higher score is worse outcome)
Post-intervention at: 1 day, 3 weeks, 6 weeks
OAB related Quality of life
Time Frame: Post-intervention at: 1 day, 3 weeks, 6 weeks
OAB-q health-related quality of life score (higher score is a better outcome)
Post-intervention at: 1 day, 3 weeks, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Methodist Hospital Research Institute

Investigators

  • Study Director: Michelle Almarez, BBA, Houston Methodist Obstetrics & Gynecology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Actual)

December 9, 2025

Study Completion (Actual)

March 20, 2026

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00037607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe