Clinical trial NCT05099419: Repetitive Transcranial Magnetic Stimulation in Women With Overactive Bladder With Urgency Incontinence
Official title: Motor Cortical Neuromodulation With Repetitive Transcranial Magnetic Stimulation in Women With Overactive Bladder and Urgency Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Overactive Bladder
Urge Incontinence
Keywords: Repetitive Transcranial Magnetic Stimulation
Overactive Bladder
Urge Incontinence
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two different intervention protocols will be administered in a crossover design.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effects of repetitive transcranial magnetic stimulation (rTMS) on pelvic-supplementary motor area (SMA) activity after low-frequency rTMS
timeFrame: Functional MRI lasting 30 minutes will be obtained immediately before low-frequency rTMS during weeks 2 and 3.
measure: Effects of repetitive transcranial magnetic stimulation (rTMS) on pelvic-supplementary motor area (SMA) activity after low-frequency rTMS
timeFrame: Functional MRI lasting 30 minutes will be obtained within 30 minutes of finishing low-frequency rTMS during weeks 2 and 3.
measure: Effects of rTMS on pelvic-SMA activity after high-frequency rTMS
timeFrame: Functional MRI lasting 30 minutes will be obtained immediately before high-frequency rTMS during weeks 2 and 3.
measure: Effects of rTMS on pelvic-SMA activity after high-frequency rTMS
timeFrame: Functional MRI lasting 30 minutes will be obtained within 30 minutes of finishing high-frequency rTMS during weeks 2 and 3.
measure: Effects of rTMS on pelvic floor muscle activity after low-frequency rTMS
timeFrame: Pelvic floor EMG will be obtained during low-frequency rTMS session, lasting 33 minutes, during weeks 2 and 3.
measure: Effects of rTMS on pelvic floor muscle activity after high-frequency rTMS
timeFrame: Pelvic floor EMG will be obtained during high-frequency rTMS session, lasting 20 minutes, during weeks 2 and 3.
Secondary outcomes:
measure: Assess subjective OAB and UUI symptom changes following rTMS
timeFrame: Subjective OAB and UUI symptoms will be assessed with the OAB-q at baseline during week 1.
measure: Assess subjective OAB and UUI symptom changes following rTMS
timeFrame: Subjective OAB and UUI symptoms will be assessed with the OAB-q after rTMS treatments during weeks 2 and 3.
measure: Assess objective OAB and UUI symptom changes following rTMS
timeFrame: Objective OAB and UUI symptoms will be assessed with a bladder diary at baseline during week 1.
measure: Assess objective OAB and UUI symptom changes following rTMS
timeFrame: Objective OAB and UUI symptoms will be assessed with a bladder diary after rTMS treatments during weeks 2 and 3.
Other outcomes:
measure: Feasibility of repetitive transcranial magnetic stimulation (rTMS) use in women with overactive bladder (OAB) and urgency urinary incontinence (UUI)
timeFrame: Feasibility will be assessed after completion of the study, up to 6 months.
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Larissa Rodriguez, MD
role: STUDY_DIRECTOR
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