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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial magnetic stimulation | Experimental | All study subjects undergo five sessions of rTMS. The 40-minute sessions target the supplemental motor area (inhibitory stimulation) and prefrontal cortex (excitatory stimulation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | Magstim Rapid2 Therapy System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Regional brain activity | Activity in the supplemental motor area and prefrontal cortex during full bladder | Post-intervention at: 0 to 3 days |
| Functional connectivity | Connectivity of regions of interest with a full bladder and empty bladder state | Post-intervention at: 0 to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic floor muscle activity | Surface electromyography of the pelvic floor muscles during rTMS sessions with subjects at rest | on day 5 of the intervention |
| Urinary frequency | Mean Voids per 24 hours (n) 2- day bladder diary (higher score is worse outcome) |
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Inclusion Criteria:
Females & Males
40 to 80 years old
3 months of OAB symptoms without active urinary tract infection currently
Bladder diary:
Montreal Cognitive Assessment (MoCA) score >10
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Almarez, BBA | Houston Methodist Obstetrics & Gynecology Department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Prospective cohort study, all subjects receive the same intervention
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| 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) | Post-intervention at: 1 day, 3 weeks, 6 weeks |
| OAB Symptom Bother | OAB-q symptom burden score (higher score is worse outcome) | 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) | Post-intervention at: 1 day, 3 weeks, 6 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |