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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
University of Southern California
Los Angeles, California, United States
RECRUITINGEffects of repetitive transcranial magnetic stimulation (rTMS) on pelvic-supplementary motor area (SMA) activity after low-frequency rTMS
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.
Time frame: Functional MRI lasting 30 minutes will be obtained immediately before low-frequency rTMS during weeks 2 and 3.
Effects of repetitive transcranial magnetic stimulation (rTMS) on pelvic-supplementary motor area (SMA) activity after low-frequency rTMS
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.
Time frame: Functional MRI lasting 30 minutes will be obtained within 30 minutes of finishing low-frequency rTMS during weeks 2 and 3.
Effects of rTMS on pelvic-SMA activity after high-frequency rTMS
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.
Time frame: Functional MRI lasting 30 minutes will be obtained immediately before high-frequency rTMS during weeks 2 and 3.
Effects of rTMS on pelvic-SMA activity after high-frequency rTMS
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.
Time frame: Functional MRI lasting 30 minutes will be obtained within 30 minutes of finishing high-frequency rTMS during weeks 2 and 3.
Effects of rTMS on pelvic floor muscle activity after low-frequency rTMS
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.
Time frame: Pelvic floor EMG will be obtained during low-frequency rTMS session, lasting 33 minutes, during weeks 2 and 3.
Effects of rTMS on pelvic floor muscle activity after high-frequency rTMS
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.
Time frame: Pelvic floor EMG will be obtained during high-frequency rTMS session, lasting 20 minutes, during weeks 2 and 3.
Assess subjective OAB and UUI symptom changes following rTMS
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.
Time frame: Subjective OAB and UUI symptoms will be assessed with the OAB-q at baseline during week 1.
Assess subjective OAB and UUI symptom changes following rTMS
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.
Time frame: Subjective OAB and UUI symptoms will be assessed with the OAB-q after rTMS treatments during weeks 2 and 3.
Assess objective OAB and UUI symptom changes following rTMS
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.
Time frame: Objective OAB and UUI symptoms will be assessed with a bladder diary at baseline during week 1.
Assess objective OAB and UUI symptom changes following rTMS
Objective OAB and UUI symptoms will be assessed with a bladder diary where participants will document number of voids, urgency episodes, and episodes of urgency incontinence in the past 24 hours.
Time frame: Objective OAB and UUI symptoms will be assessed with a bladder diary after rTMS treatments during weeks 2 and 3.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.