Investigation of PEMF Therapy for Female Patients With IC/BPS (NCT05149573) | Clinical Trial Compass
RecruitingNot Applicable
Investigation of PEMF Therapy for Female Patients With IC/BPS
United States75 participantsStarted 2022-08-29
Plain-language summary
The purpose of this study is to gather information about the safety and effectiveness of the non-pharmacological (non-drug), non-invasive treatment known as low-frequency pulsed electromagnetic field (PEMF) therapy. The study team will distribute the PEMF device to female adults with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) to measure its ability to decrease bladder and pelvic pain as well as other urinary symptoms associated with IC/BPS. There are two sequential Aims in this study and subjects will be recruited to participate in only one Aim. In both Aims, data will be collected at baseline/enrollment, 4-weeks after using PEMF therapy, and 8, 12, and 16 weeks post-enrollment.
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 IC/PS
* Current numeric rating scale (NRS) score of ≥ 6
* History of cystoscopy with hydrodistension with bladder capacity determination under anesthesia
* No cognitive deficits
Exclusion Criteria:
* History of bladder, ovarian, vaginal cancer
* History of urethral diverticulum
* History of radiation cystitis
* History of spinal cord injury or spina bifida
* History of Parkinson's disease, multiple sclerosis, or stroke
* Current placement of a pacemaker or metal prosthesis
* Active urinary tract infection
* BMI \> 40
* Residual urine of \> 100cc
* Current 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, as measured by the Brief Pain Inventory (BPI) Short Form
Timeframe: Baseline
2
Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form
Timeframe: Week 4
3
Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form
Timeframe: Week 8
4
Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form
Timeframe: Week 12
5
Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form