Status:
NOT_YET_RECRUITING
Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Interstitial Cystitis
Chronic Interstitial Cystitis
Eligibility:
FEMALE
18-80 years
Phase:
NA
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 blad...
Detailed Description
IC/BPS is a chronic condition affecting the urinary bladder, causing generalized pelvic pain and urinary symptoms such as urgency, frequency, and nocturia. Although it is not a life-threatening condit...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06013449
Start Date
March 1 2026
End Date
May 1 2027
Last Update
July 10 2025
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157