Neuromodulation for bladder pain in women
Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome: Reducing Pain by Improving Brain and Muscle Activity
This study is testing whether a brain stimulation technique can help women with bladder pain feel better by looking at how it affects their brain and muscle activity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Southern California Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04734847 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of repetitive transcranial magnetic stimulation (rTMS) to alleviate pain in women suffering from Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). It aims to explore the effects of rTMS on brain activity and pelvic floor muscle function, addressing limitations of previous research by linking pain reduction to changes in brain and muscle activity. The study will recruit 50 women diagnosed with IC/BPS and assess their responses to rTMS compared to a sham treatment. Through functional MRI and electromyography, the study seeks to develop a causal model of IC/BPS symptoms.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a diagnosis of IC/BPS and persistent urologic symptoms.
Not a fit: Patients with ongoing neurological conditions affecting bladder function or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel, non-invasive treatment option for women suffering from chronic bladder pain.
How similar studies have performed: While preliminary evidence suggests rTMS may help with chronic pain, this specific application for IC/BPS is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be at least 18 years old. 2. Be female. 3. Have a diagnosis of IC/BPS by the referring physician, with urologic symptoms present a majority of the time during the most recent 3 months 4. Screen within standard limits for pelvic pain Exclusion Criteria: 1. Symptomatic urethral stricture 2. On-going neurological conditions affecting the bladder or bowel 3. Active auto-immune or infectious disorders 4. History of cystitis caused by tuberculosis or radiation or chemotherapies 5. History of non-dermatologic cancer 6. Current major psychiatric disorders 7. Severe cardiac, pulmonary, renal, or hepatic disease 8. Conditions or the use of medical devices that are contraindications for either fMRI or rTMS procedures, including pregnancy, seizure disorders, or chronic headaches
Where this trial is running
Los Angeles, California
- University of Southern California — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Jason J Kutch, PhD — University of Southern California
- Study coordinator: Jason J Kutch, PhD
- Email: kutch@pt.usc.edu
- Phone: 323-442-2932
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.