Repetitive Transcranial Magnetic Stimulation in Women With Overactive Bladder With Urgency Incontinence
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Overactive bladder (OAB) affects an estimated 16-30% of women in the US and urgency urinary incontinence (UUI) affects 7-11% of women with OAB. It is known that repetitive transcranial magnetic stimulation (rTMS) over the supplementary motor area (SMA) can modulate the pelvic floor muscle activity with potential benefits for various urologic conditions. The goal of this study is to assess feasibility of rTMS as a treatment option for OAB with UUI by determining which rTMS frequency is most effective in targeting sensory components of OAB, namely urinary urgency, and also in targeting the brain network known to be involved in OAB.
Full description
Eligible participants with OAB and UUI will undergo resting state functional MRI of the brain to map baseline brain activity. Participants will then undergo rTMS of the SMA with electromyography (EMG) monitoring of the pelvic floor muscles. They will then undergo another MRI to assess and changes in brain activity due to rTMS. Participants will be asked about their bladder symptoms over the course of the study.
The study will have a crossover design. The investigators plan to recruit 10 women with symptoms of OAB and UUI. During the first week, participants will be screened, asked to fill out a bladder questionnaire, and to complete a bladder diary. During the next two weeks, participants will undergo rTMS and functional MRI of the brain to assess brain activity.
All participants will undergo two different known rTMS protocols for the pelvic floor, high-frequency and low-frequency, separated by a 1-week washout period. Each participant will be randomized to which protocol they will have first. In total, 5 participants will have started with high-frequency rTMS first and 5 participants will have started with low-frequency rTMS. At the end, all participants will have undergone both high- and low-frequency rTMS.
The primary objective of the study is to assess the feasibility of rTMS in patients with OAB and UUI, which will be assessed with recruitment and retention rates of participants. The investigators also aim to determine if SMA activity mediates OAB symptoms and pelvic floor muscle tone using functional MRI of the brain. Finally, the investigators want to assess bladder symptoms following rTMS using participant questionnaires and number of UUI episodes.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 18 years or older
- female
- diagnosis of overactive bladder with symptoms of urgency urinary incontinence majority of the time during the last 3 months
Exclusion criteria
- current use of sacral neuromodulation
- new initiation of overactive bladder treatment within the last 6 weeks
- has had intradetrusor onabotulinumtoxinA injections in the last 3 months
- neurological disease affecting the bladder or bowel
- incomplete bladder emptying
- history of urologic cancer
- active infection
- history of cystitis caused by tuberculosis, radiation, or chemotherapies
- severe pelvic pain
- pregnancy
- post-partum 6 weeks
- post-surgical 6 weeks
- cannot undergo MRI
- history of epilepsy or seizures
Trial design
Primary purpose
Allocation
Interventional model
Masking
10 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Rita Jen, MD
Data sourced from clinicaltrials.gov
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