4-Week Treatment with no Maintenance Period for Bladder Pain Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Bladder Pain Syndrome+5 More
Pulsed Electromagnetic Field (PEMF) Device - Device
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is looking at whether a non-invasive, non-drug therapy called low-frequency pulsed electromagnetic field (PEMF) therapy is safe and effective for treating Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).

Eligible Conditions
  • Bladder Pain Syndrome
  • Interstitial Cystitis
  • Interstitial Cystitis, Chronic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Baseline, Week 4, Week 8, Week 12, and Week 16

Baseline
Pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form
Week 16
Change in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms, as measured by O'Leary Sant Interstitial Cystitis Symptom Index and Problem Index (ICSI/ICPI)
Change in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms, as measured by Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale
Change in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms, as measured by the Global Response Assessment (GRA)
Change in Urinary symptoms, as measured by 3-day voiding diaries
Week 16
Pain

Trial Safety

Trial Design

3 Treatment Groups

4-Week Treatment with no Maintenance Period
1 of 3
4-Week Treatment with 1-Week-Per-Month Maintenance Period for an Additional 3 Mo...
1 of 3
4-Week Sham Treatment with no Maintenance Period
1 of 3

Active Control

Non-Treatment Group

75 Total Participants · 3 Treatment Groups

Primary Treatment: 4-Week Treatment with no Maintenance Period · Has Placebo Group · N/A

4-Week Sham Treatment with no Maintenance Period
Device
ShamComparator Group · 1 Intervention: Sham Pulsed Electromagnetic Field (PEMF) Device · Intervention Types: Device
4-Week Treatment with no Maintenance Period
Device
ActiveComparator Group · 1 Intervention: Pulsed Electromagnetic Field (PEMF) Device · Intervention Types: Device
4-Week Treatment with 1-Week-Per-Month Maintenance Period for an Additional 3 Months
Device
ActiveComparator Group · 1 Intervention: Pulsed Electromagnetic Field (PEMF) Device · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 4, week 8, week 12, and week 16

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,114 Previous Clinical Trials
1,129,491 Total Patients Enrolled
2 Trials studying Bladder Pain Syndrome
110 Patients Enrolled for Bladder Pain Syndrome
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,125 Previous Clinical Trials
4,063,043 Total Patients Enrolled
1 Trials studying Bladder Pain Syndrome
78 Patients Enrolled for Bladder Pain Syndrome
Stephen J Walker, PhDPrincipal InvestigatorWake Forest University Health Sciences

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a cystoscopy with hydrodistension with bladder capacity determination under anesthesia.
You have previously been diagnosed with IC/PS.
You have a current numeric rating scale (NRS) score of ≥ 6.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: November 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References