CompletedNot Applicable

PEMF Therapy to Treat Interstitial Cystitis/Bladder Pain Syndrome

United States10 participantsStarted 2021-02-24

Plain-language summary

The purpose of this study is to gather information from the investigation of a non-pharmacological (non-drug) treatment known as low frequency pulsed electromagnetic field (PEMF). The study team will be distributing the PEMF therapy to female subjects with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) to measure its ability to decrease pelvic pain. The results, from multiple questionnaires and voiding diaries, will be compared when participants are enrolled for treatment, at 4 weeks after using PEMF therapy, and 12 weeks post-enrollment.

Who can participate

Age range18 Years – 80 Years

SexFEMALE

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: * Female patients between 18 and 80 years old * Participants must have already been diagnosed with interstitial cystitis/bladder pain syndrome * Subjects must have a bladder capacity greater than 400 cc * Participants must have scored at least a 6 or higher on Numeric Rating Scale questionnaire * Participants must not have any cognitive disabilities * Participants must not have taken any narcotic medication for at least three months before being enrolled in this clinical trial Exclusion Criteria: * Participants must not have any history of bladder, uterine, ovarian, or vaginal cancer, urethral diverticulum, spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida, radiation cystitis, cyclophosphamide treatment, or genital herpes * Patients cannot have an implanted pace-maker or metal prosthesis * Participants cannot have a urinary tract infection at the time of enrollment or be currently pregnant * Patients must not have a body mass index greater than 40

What they're measuring

Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)

Timeframe: Baseline before beginning treatment

Change From Baseline Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)

Timeframe: Week 4

Change From Baseline Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)

Timeframe: Week 12

Trial details

NCT IDNCT04540887

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-30

Results submitted2022-04-27

View on ClinicalTrials.gov More Interstitial Cystitis trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)

Timeframe: Baseline before beginning treatment

Change From Baseline Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)

Timeframe: Week 4

Change From Baseline Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)

Timeframe: Week 12