rTMS in Overactive Bladder

Not Applicable

Recruiting

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

Brief 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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Transcranial magnetic stimulation	Transcranial Magnetic Stimulation	All study subjects undergo five sessions of rTMS. The 40-minute sessions target the supplemental motor area (inhibitory stimulation) and prefrontal cortex (excitatory stimulation)

Primary Outcome Measures

Name	Time	Method
Functional connectivity	Post-intervention at: 0 to 3 days	Connectivity of regions of interest with a full bladder and empty bladder state
Regional brain activity	Post-intervention at: 0 to 3 days	Activity in the supplemental motor area and prefrontal cortex during full bladder

Secondary Outcome Measures

Name	Time	Method
Pelvic floor muscle activity	on day 5 of the intervention	Surface electromyography of the pelvic floor muscles during rTMS sessions with subjects at rest
Urinary frequency	Post-intervention at: 1 day, 3 weeks, 6 weeks	Mean Voids per 24 hours (n) 2- day bladder diary (higher score is worse outcome)
Urgency episodes	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)
OAB Symptom Bother	Post-intervention at: 1 day, 3 weeks, 6 weeks	OAB-q symptom burden score (higher score is worse outcome)
OAB related Quality of life	Post-intervention at: 1 day, 3 weeks, 6 weeks	OAB-q health-related quality of life score (higher score is a better outcome)