rTMS in Overactive Bladder (TMS_OAB)

The Methodist Hospital Research Institute (TMHRI)

Status: Enrolling

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

Treatments: Device: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06198439

PRO00037607

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Transcranial magnetic stimulation

Experimental group

Description:

All study subjects undergo five sessions of rTMS. The 40-minute sessions target the supplemental motor area (inhibitory stimulation) and prefrontal cortex (excitatory stimulation)

Treatment:

Device: Transcranial Magnetic Stimulation