Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations

NCT06013449 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB00100535
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to test the idea that Pulsed Electromagnetic Field (PEMF) therapy will serve as a safe therapeutic modality that can effectively be administered simultaneously with bladder instillations of a bupivacaine-heparin cocktail to improve the chronic pain and/or associated symptoms of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) patients. The study team will distribute the PEMF device to female adults with IC/BPS who have been prescribed bladder instillations of bupivacaine-heparin to see if PEMF therapy in conjunction with bladder instillations of heparin and bupivacaine may be more effective in reducing pain levels and symptomatology of IC/BPS than instillations alone.

Conditions

Interstitial Cystitis; Chronic Interstitial Cystitis; Bladder Pain Syndrome

Keywords

interstitial cystitis; bladder pain syndrome; painful bladder; chronic pelvic pain; urinary urgency; urinary frequency; pulsed electromagnetic field; PEMF; bladder instillation

Outcome Measures

Primary Outcomes (3)

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

  The BPI Short Form is a validated questionnaire used to assess the severity of systemic and pelvic pain, and its interference in overall quality of life. Pain severity is measured through four 11-point numeric rating scales (NRS) assessing pain at its "worst", "least" and "average", within the past week, and pain "right now' (at the time of short form completion), with a composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured by 7 scales, with scores ranging from 0 (does not interfere) to 10 (completely interferes), for different daily activities. The composite score for the interference items is used to assess overall pain interference, with higher scores indicating greater symptom severity, and a change in 2 points indicating significant change in pain. The form also includes 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.

  Baseline

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

  The BPI Short Form is a validated questionnaire used to assess the severity of systemic and pelvic pain, and its interference in overall quality of life. Pain severity is measured through four 11-point numeric rating scales (NRS) assessing pain at its "worst", "least" and "average", within the past week, and pain "right now' (at the time of short form completion), with a composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured by 7 scales, with scores ranging from 0 (does not interfere) to 10 (completely interferes), for different daily activities. The composite score for the interference items is used to assess overall pain interference, with higher scores indicating greater symptom severity, and a change in 2 points indicating significant change in pain. The form also includes 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.

  Week 3

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

  The BPI Short Form is a validated questionnaire used to assess the severity of systemic and pelvic pain, and its interference in overall quality of life. Pain severity is measured through four 11-point numeric rating scales (NRS) assessing pain at its "worst", "least" and "average", within the past week, and pain "right now' (at the time of short form completion), with a composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured by 7 scales, with scores ranging from 0 (does not interfere) to 10 (completely interferes), for different daily activities. The composite score for the interference items is used to assess overall pain interference, with higher scores indicating greater symptom severity, and a change in 2 points indicating significant change in pain. The form also includes 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.

  Week 6

Secondary Outcomes (6)

• 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)

  Baseline, Week 3, and Week 6

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

  Baseline, Week 3 and Week 6

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

  Baseline, Week 3 and Week 6

• Change in Urinary Symptom scores, as measured by 3-day voiding diaries - Number of Urine Voids

  Baseline, Week 3 and Week 6

• Change in Urinary Symptom scores, as measured by 3-day voiding diaries - Mean change in Total Volume of Voided Urine

  Baseline, Week 3 and Week 6

Study Arms (2)

6-week Pulsed Electromagnetic Field treatment with intravesical bupivacaine/heparin instillations

ACTIVE COMPARATOR

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.

Device: Pulsed Electromagnetic Field (PEMF) Device

6-week Sham Treatment with intravesical bupivacaine/heparin instillations

SHAM COMPARATOR

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.

Device: Sham Pulsed Electromagnetic Feild (PEMF) Device

Interventions

Sham Pulsed Electromagnetic Feild (PEMF) Device DEVICE

The sham PEMF device appears identical to the BEMER PEMF device, with all of the same components and accessories, but does not emit a pulsed electromagnetic field.

Also known as: BEMER Sham Device

6-week Sham Treatment with intravesical bupivacaine/heparin instillations

Pulsed Electromagnetic Field (PEMF) Device DEVICE

Pulsed Electromagnetic Field (PEMF) Device BEMER Device consist of a total body mat (B. BODY) plus a targeted pelvic mat (B.PAD), and a Control Unit which powers the device and logs usage. Both B.BODY and B.PAD must be plugged into the Control Unit simultaneously and activated individually. B. Body must be placed on a flat surface (i.e. bed, floor, reclining chair etc.) for best results.

Also known as: BEMER PEMF, BEMER B. BODY, BEMER B. PAD, BEMER Control Unit

6-week Pulsed Electromagnetic Field treatment with intravesical bupivacaine/heparin instillations

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Subject must be biologically female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously established clinical diagnosis of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
• Current Numeric Rating Scale (NRS) greater than or equal to 5
• History of cystoscopy with hydrodistension with bladder capacity determination under anesthesia
• No contraindications to the instillation solution
• No cognitive deficits

You may not qualify if:

• History of bladder, ovarian or vaginal cancer
• History of urethral diverticulum
• History of radiation cystitis
• History of spinal cord injury or spina bifida
• History of Parkinson's Disease
• History of Multiple Sclerosis (MS)
• History of Stroke
• History of genital herpes
• History of or current cyclophosphamide treatment
• Current placement of a pacemaker or metal prothesis
• Active urinary tract infection
• BMI \>40
• Residual urine of \>100 cc
• Currently pregnant

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Stephen J Walker, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen J Walker, PhD

CONTACT

336-713-7272; swalker@wakehealth.edu

Kaylee A Ferrara, BS

CONTACT

336-713-1693; Kaylee.Ferrara@Advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a sham-control, single-blind clinical series. Following in-clinic training, half of the participants will be sent home with Pulsed Electromagnetic Field (PEMF) devices (pre-set to deliver the same level of energy each time) and the other half will be sent home with sham mats. The sham device is identical in every way to the treatment device except the sham console does not deliver a pulsed electromagnetic field. Patients will be randomly assigned (1:1) to either the PEMF treatment or the sham device. Both groups will be instructed on how to self-administer PEMF therapy for 8 minutes. All participants will be instructed to only use the PEMF devices immediately following each instillation, while they are holding the instillation solution in their bladder.

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)