Overactive Bladder, Urge Incontinence
Conditions
Keywords
Repetitive Transcranial Magnetic Stimulation, Overactive Bladder, Urge Incontinence
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.
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation
rTMS uses pulses of magnetic energy to non-invasively stimulate the brain. The rTMS device to be used in this study is the Magstim Rapid2 Plus1. The rTMS device is connected to an active figure-of-eight coil which rests against the scalp and delivers the magnetic energy to the brain. The rTMS protocol is specified by the parameters of pulse frequency, duration of continuous pulse delivery, intensity, and stimulation location. Each participant will receive two different standard rTMS protocols that have been used in past research studies for modulation of pelvic floor tone delivered over the motor cortex in an area that is known to control pelvic floor muscles.
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two different intervention protocols will be administered in a crossover design.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of repetitive transcranial magnetic stimulation (rTMS) on pelvic-supplementary motor area (SMA) activity after low-frequency rTMS | Functional MRI lasting 30 minutes will be obtained immediately before low-frequency rTMS during weeks 2 and 3. | The effects of low-frequency rTMS on brain activity will be evaluated with functional MRI performed immediately before the rTMS session and also after 30 minutes after the session in order to document interval changes. |
| Effects of rTMS on pelvic-SMA activity after high-frequency rTMS | Functional MRI lasting 30 minutes will be obtained immediately before high-frequency rTMS during weeks 2 and 3. | The effects of high-frequency rTMS on brain activity will be evaluated with functional MRI performed immediately before the rTMS session and also after 30 minutes after the session in order to document interval changes. |
| Effects of rTMS on pelvic floor muscle activity after low-frequency rTMS | Pelvic floor EMG will be obtained during low-frequency rTMS session, lasting 33 minutes, during weeks 2 and 3. | The effects of low-frequency rTMS on pelvic floor muscle activity will be evaluated with pelvic floor electromyography (EMG) obtained with a rectal sensor during the low-frequency rTMS session. |
| Effects of rTMS on pelvic floor muscle activity after high-frequency rTMS | Pelvic floor EMG will be obtained during high-frequency rTMS session, lasting 20 minutes, during weeks 2 and 3. | The effects of high-frequency rTMS on pelvic floor muscle activity will be evaluated with pelvic floor electromyography (EMG) obtained with a rectal sensor during the high-frequency rTMS session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess subjective OAB and UUI symptom changes following rTMS | Subjective OAB and UUI symptoms will be assessed with the OAB-q at baseline during week 1. | OAB and UUI symptoms will be assessed with the overactive bladder questionnaire (OAB-q). This validated instrument contains 33 questions regarding bladder symptoms and quality of life associated with OAB rated on a 6-point Likert scale. The total score ranges from 0 to 100 with higher scores reflecting greater degree of symptom bother. |
| Assess objective OAB and UUI symptom changes following rTMS | Objective OAB and UUI symptoms will be assessed with a bladder diary at baseline during week 1. | Objective OAB and UUI symptoms will be assessed with a bladder diary where participants will document number of voids, volume of voids, urgency episodes, and episodes of urgency incontinence in the past 24 hours. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of repetitive transcranial magnetic stimulation (rTMS) use in women with overactive bladder (OAB) and urgency urinary incontinence (UUI) | Feasibility will be assessed after completion of the study, up to 6 months. | Feasibility will be assessed with recruitment and retention rates, time required to achieve target number of eligible participants, and completion rates of the study. |
Countries
United States
Contacts
Primary ContactRita Jen, MD
Outcome results
None listed