Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations (NCT06013449) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations
United States20 participantsStarted 2026-09
Plain-language summary
The objective of this study is to test the idea that Pulsed Electromagnetic Field (PEMF) therapy will serve as a safe therapeutic modality that can effectively be administered simultaneously with bladder instillations of a bupivacaine-heparin cocktail to improve the chronic pain and/or associated symptoms of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) patients. The study team will distribute the PEMF device to female adults with IC/BPS who have been prescribed bladder instillations of bupivacaine-heparin to see if PEMF therapy in conjunction with bladder instillations of heparin and bupivacaine may be more effective in reducing pain levels and symptomatology of IC/BPS than instillations alone.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Previously established clinical diagnosis of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
* Current Numeric Rating Scale (NRS) greater than or equal to 5
* History of cystoscopy with hydrodistension with bladder capacity determination under anesthesia
* No contraindications to the instillation solution
* No cognitive deficits
Exclusion Criteria:
* History of bladder, ovarian or vaginal cancer
* History of urethral diverticulum
* History of radiation cystitis
* History of spinal cord injury or spina bifida
* History of Parkinson's Disease
* History of Multiple Sclerosis (MS)
* History of Stroke
* History of genital herpes
* History of or current cyclophosphamide treatment
* Current placement of a pacemaker or metal prothesis
* Active urinary tract infection
* BMI \>40
* Residual urine of \>100 cc
* Currently pregnant
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pelvic pain scores as measured by the Brief Pain Inventory (BPI) Short Form - Baseline
Timeframe: Baseline
2
Pelvic pain scores as measured by the Brief Pain Inventory (BPI) Short Form - Week 3
Timeframe: Week 3
3
Pelvic pain scores as measured by the Brief Pain Inventory (BPI) Short Form - Week 6