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PEMF Therapy for Interstitial Cystitis

N/A

Waitlist Available

Led By Stephen J Walker, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previously established clinical diagnosis of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 3 and week 6

Awards & highlights

Study Summary

This trial aims to test if using PEMF therapy with bladder instillations can reduce pain and symptoms in people with IC/BPS.

Who is the study for?

This trial is for adult women with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) who experience significant pain (NRS ≥ 5). They must have had a cystoscopy with bladder capacity measurement and no cognitive deficits. Exclusions include a history of certain cancers, urinary conditions, neurological disorders, pregnancy, pacemaker or metal prosthesis presence, active infections, or extreme obesity (BMI >40).Check my eligibility

What is being tested?

The study tests if Pulsed Electromagnetic Field (PEMF) therapy combined with bladder instillations of bupivacaine-heparin can better reduce chronic pain and symptoms in IC/BPS patients than the instillation alone. Participants will receive either PEMF therapy or a sham device alongside their prescribed treatment.See study design

What are the potential side effects?

Potential side effects may include discomfort from the PEMF device application area or reactions to the bupivacaine-heparin cocktail such as local irritation. The study aims to establish the safety profile of simultaneous PEMF therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Interstitial Cystitis or Bladder Pain Syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 3 and week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 3 and week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 3 and week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pelvic pain scores as measured by the Brief Pain Inventory (BPI) Short Form - Baseline

Pelvic pain scores as measured by the Brief Pain Inventory (BPI) Short Form - Week 3

Pelvic pain scores as measured by the Brief Pain Inventory (BPI) Short Form - Week 6

Secondary outcome measures

Change in Interstitial Cystitis/ Bladder Pain Syndrome (IC/BPS) scores, as measured by the Global Response Assessment (GRA)

Change in Interstitial Cystitis/ Bladder Pain Syndrome (IC/BPS) scores, as measured by the O'Leary Sant Interstitial Cystitis Symptom Index and Problem Index (ICSI/ICPI)

Change in Interstitial Cystitis/ Bladder Pain Syndrome (IC/BPS) scores, as measured by the Pelvic Pain and Urgency Frequency (PUF) Patient Symptom Scale

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: 6-week Pulsed Electromagnetic Field treatment with intravesical bupivacaine/heparin instillationsActive Control1 Intervention

Participants will be instructed to self-administer pulsed electromagnetic field therapy (PEMF) devices immediately following each intravesical bupivacaine/heparin instillation, while they are holding the instillation solution in their bladder. PEMF therapy will be self-administered using the B. Body (full body mat) and B. Pad (targeted pelvic pad). The participant will lie the B. Body mat on any flat dry surface and lay on the mat with the smaller B. Pad placed directly over the pelvic area. The PEMF device (attached to the control B. Box) has been pre-programmed to deliver the same energy level every time. Participants will be instructed to administer this home treatment in conjunction with their self-administered bladder instillations of bupivacaine/heparin for 8-minute sessions, three times a week over a 6 week period. At the mid way point (3 weeks) and after completion (6 weeks) participants will complete the online questionnaires. At 6 weeks the PEMF device is returned.

Group II: 6-week Sham Treatment with intravesical bupivacaine/heparin instillationsPlacebo Group1 Intervention

Participants will be provided with a sham B. Body and B. Pad that appears identical to the active pulsed electromagnetic field (PEMF) device. The participant will lie the sham B- Body mat on any flat dry surface and lay on the mat with with the smaller sham B. Pad placed directly over the pelvic area. The participant will be instructed to administer this sham treatment immediately following each intravesical bupivacaine/heparin instillation, while they are holding the instillation solution in their bladder. Participants will be instructed to administer this sham treatment in conjunction with their self-administered bladder instillations of bupivacaine/heparin for 8-minute sessions, three times a week over a 6 week period. At the mid way point (3 weeks) and after completion (6 weeks) participants will complete the online questionnaires. At 6 weeks the sham PEMF device is returned.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,239 Previous Clinical Trials

1,004,163 Total Patients Enrolled

6 Trials studying Interstitial Cystitis

242 Patients Enrolled for Interstitial Cystitis

Stephen J Walker, PhDPrincipal InvestigatorWake Forest University Health Sciences

2 Previous Clinical Trials

85 Total Patients Enrolled

2 Trials studying Interstitial Cystitis

85 Patients Enrolled for Interstitial Cystitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the principal aim of this research endeavor?

"The primary endpoint of this study, which will be scrutinised over a period extending to Week 3, is the Pelvic pain score as assessed by the Brief Pain Inventory (BPI) Short Form - Week 6. Additionally, Change in Interstitial cystitis/ Bladder Pain Syndrome (IC/BPS) scores tracked via two validated metrics; namely, the Pelvic Pain and Urgency Frequency (PUF) Patient Symptom Scale that gauges severity & annoyance of symptoms related to IC/BPS on an 7-point scale from 0-4 times for frequency measures and 1-3 for intensity measure producing one composite score"

Answered by AI

Do I meet the criteria to be included in this research?

"This clinical trial is looking to admit 20 individuals aged 18-80 who suffer from interstitial cystitis. Requirements for applicants include a current Numeric Rating Scale score of at least 5, an established diagnosis of IC/BPS, and no cognitive impairments."

Answered by AI

Is this research endeavor currently seeking participants?

"According to clinicialtrials.gov, this clinical trial is not presently enlisting participants. It was posted on September 1st 2023 and last updated August 22nd 2023. Unfortunately, it is no longer recruiting individuals however 1511 other trials are looking for volunteers at the present juncture."

Answered by AI

Does this medical study permit participation from individuals aged 60 and over?

"To become a part of this research program, applicants must be between the ages 18 and 80. Furthermore, there are 388 trials available specifically for those under 18 years old and 1062 appropriate for individuals 65 or older."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations

2024. "Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06013449.

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