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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Magstim Rapid2 Therapy System
Houston Methodist Hospital
Houston, Texas, United States
RECRUITINGRegional brain activity
Activity in the supplemental motor area and prefrontal cortex during full bladder
Time frame: Post-intervention at: 0 to 3 days
Functional connectivity
Connectivity of regions of interest with a full bladder and empty bladder state
Time frame: Post-intervention at: 0 to 3 days
Pelvic floor muscle activity
Surface electromyography of the pelvic floor muscles during rTMS sessions with subjects at rest
Time frame: on day 5 of the intervention
Urinary frequency
Mean Voids per 24 hours (n) 2- day bladder diary (higher score is worse outcome)
Time frame: Post-intervention at: 1 day, 3 weeks, 6 weeks
Urgency episodes
Mean urgency episodes per 24 hours (n) 2- day bladder diary (higher score is worse outcome)
Time frame: Post-intervention at: 1 day, 3 weeks, 6 weeks
OAB Symptom Bother
OAB-q symptom burden score (higher score is worse outcome)
Time frame: Post-intervention at: 1 day, 3 weeks, 6 weeks
OAB related Quality of life
OAB-q health-related quality of life score (higher score is a better outcome)
Time frame: Post-intervention at: 1 day, 3 weeks, 6 weeks
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