rTMS in Overactive Bladder

NCT06198439 | Completed DMC FDA Device

• 1 other identifier: PRO00037607
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Overactive Bladder Syndrome; Urge Incontinence; Urgency-frequency Syndrome; Urinary Incontinence; Urinary Incontinence, Urge; Overactive Bladder

Outcome Measures

Primary Outcomes (2)

• Regional brain activity

  Activity in the supplemental motor area and prefrontal cortex during full bladder

  Post-intervention at: 0 to 3 days

• Functional connectivity

  Connectivity of regions of interest with a full bladder and empty bladder state

  Post-intervention at: 0 to 3 days

Secondary Outcomes (5)

• Pelvic floor muscle activity

  on day 5 of the intervention

• Urinary frequency

  Post-intervention at: 1 day, 3 weeks, 6 weeks

• Urgency episodes

  Post-intervention at: 1 day, 3 weeks, 6 weeks

• OAB Symptom Bother

  Post-intervention at: 1 day, 3 weeks, 6 weeks

• OAB related Quality of life

  Post-intervention at: 1 day, 3 weeks, 6 weeks

Study Arms (1)

Transcranial magnetic stimulation

EXPERIMENTAL

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

Interventions

Transcranial Magnetic Stimulation DEVICE

Magstim Rapid2 Therapy System

Also known as: Magstim Rapid2 Therapy System

Transcranial magnetic stimulation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females \& Males
• to 80 years old
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urinary Incontinence

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Michelle Almarez, BBA

  Houston Methodist Obstetrics & Gynecology Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort study, all subjects receive the same intervention

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: January 10, 2024
• Study Start: January 8, 2024
• Primary Completion: December 9, 2025
• Study Completion: March 20, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)