rTMS in Overactive Bladder

Urinary Incontinence Clinical Trial

— TMS_OAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06198439
• Other study ID #: PRO00037607
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: July 2026

Study information

• Verified date: January 2024
• Source: The Methodist Hospital Research Institute
• Contact: Michelle Almarez, BBA
• Phone: 713-441-5920
• Email: almarez[@]houstonmethodist.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Overactive Bladder
• Overactive Bladder Syndrome
• Syndrome
• Urge Incontinence
• Urgency-frequency Syndrome
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Device:
• Transcranial Magnetic Stimulation
Magstim Rapid2 Therapy System

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional brain activity	Activity in the supplemental motor area and prefrontal cortex during full bladder	Post-intervention at: 0 to 3 days
Primary	Functional connectivity	Connectivity of regions of interest with a full bladder and empty bladder state	Post-intervention at: 0 to 3 days
Secondary	Pelvic floor muscle activity	Surface electromyography of the pelvic floor muscles during rTMS sessions with subjects at rest	on day 5 of the intervention
Secondary	Urinary frequency	Mean Voids per 24 hours (n) 2- day bladder diary (higher score is worse outcome)	Post-intervention at: 1 day, 3 weeks, 6 weeks
Secondary	Urgency episodes	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
Secondary	OAB Symptom Bother	OAB-q symptom burden score (higher score is worse outcome)	Post-intervention at: 1 day, 3 weeks, 6 weeks
Secondary	OAB related Quality of life	OAB-q health-related quality of life score (higher score is a better outcome)	Post-intervention at: 1 day, 3 weeks, 6 weeks