Recruiting
Early Phase 1

TMS

Sponsor:

University of Southern California

Code:

NCT05099419

Conditions

Overactive Bladder

Urge Incontinence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Repetitive Transcranial Magnetic Stimulation

Study Details

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.

Conditions

Overactive Bladder

Urge Incontinence

Study ID

NCT05099419

Start date

Oct 28, 2021

Status verified date

Nov, 2021

Completion date

Jun 30, 2022

Anticipated

Primary completion date

Apr 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High Frequency rTMS Protocol

High frequency with 10 Hz at 80% motor threshold intensity with figure-of-eight coil for a total of 2,000 pulses. Pulses will be delivered in 10-second trains with a 50-second pause between the trains.

experimental: Low Frequency rTMS Protocol

Low frequency 1 Hz at 80% motor threshold intensity with figure-of-eight coil for a total of 2,000 pulses. Pulses will be delivered continuously.

Interventions

Repetitive 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.

Primary outcome measure

  • Effects of repetitive transcranial magnetic stimulation (rTMS) on pelvic-supplementary motor area (SMA) activity after low-frequency rTMS [ 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 [ 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 [ 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 [ 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 [ 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 [ Time Frame: Pelvic floor EMG will be obtained during high-frequency rTMS session, lasting 20 minutes, during weeks 2 and 3. ]

Central Contacts and Locations

Central contacts

Rita Jen, MD

626-720-4051ritajen@usc.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Rita Jen, MD

626-720-4051ritajen@usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Nov 17, 2021

Last verified

Nov, 2021

Keywords

  • Repetitive Transcranial Magnetic Stimulation
  • Overactive Bladder
  • Urge Incontinence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2021-11-17.