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Completed

NCT Number: NCT06198439

rTMS in 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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Urge Incontinence Urgency-frequency Syndrome Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Magnetic Stimulation

Device

Magstim Rapid2 Therapy System

Other names: Magstim Rapid2 Therapy System

Primary outcomes

  1. Regional brain activity

    Time frame: Post-intervention at: 0 to 3 days

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

  2. Functional connectivity

    Time frame: Post-intervention at: 0 to 3 days

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

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

  4. OAB Symptom Bother

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

    OAB-q symptom burden score (higher score is worse outcome)

  5. 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)

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

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

Acronym: TMS_OAB

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 10, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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