Clinical Trials Directory

Trials / Completed

CompletedNCT06198439

rTMS in Overactive Bladder

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
14 (actual)
Sponsor
The Methodist Hospital Research Institute · Academic / Other
Sex
All
Age
40 Years – 80 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DEVICETranscranial Magnetic StimulationMagstim Rapid2 Therapy System

Timeline

Start date
2024-01-08
Primary completion
2025-12-09
Completion
2026-03-20
First posted
2024-01-10
Last updated
2026-03-24

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06198439. Inclusion in this directory is not an endorsement.