N/A N=10 Treatment

PEMF Therapy to Treat Interstitial Cystitis/Bladder Pain Syndrome

Interstitial Cystitis · Chronic Interstitial Cystitis · Bladder Pain Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT04540887 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2022

Primary outcome: Primary: Pelvic Pain, as Measured by the Numeric Rating Scale (NRS) — 6.70 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Pulsed Electromagnetic Field (PEMF) Therapy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Wake Forest University Health Sciences
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)	6.70	—
PRIMARY Change From Baseline Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)	5.34	—
PRIMARY Change From Baseline Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)	5.34	—
SECONDARY Change in IC/BPS Symptoms, as Measured by O'Leary-Sant Interstitial Cystitis Problem Index (ICPI)	13; 9.125; 10.75	—
SECONDARY Change in IC/BPS Symptoms, as Measured by Wake Forest Baptist Health IC/BPS Global Response Assessment (GRA)	0; 2; 2	—
SECONDARY Change in IC/BPS Symptoms, as Measured by O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)	13.875; 9; 10	—
SECONDARY Change in IC/BPS Symptoms, as Recorded in Patient Voiding Diary - Void and Intake Measurements	2808.68; 2511.67; 406.71; 454.29; 215.45; 229.67	—
SECONDARY Change in IC/BPS Symptoms, as Recorded in Patient Voiding Diary - Number of Voids	13.79; 11.52	—
SECONDARY Change in IC/BPS Symptoms, as Recorded in Patient Voiding Diary - Urgency Score	2.12; 1.91	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04540887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.