Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Aug 22, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for women suffering from Interstitial Cystitis (IC) and Bladder Pain Syndrome (BPS), conditions that cause chronic bladder pain and discomfort. The study aims to find out if using a device that delivers Pulsed Electromagnetic Field (PEMF) therapy, alongside a special solution of bupivacaine and heparin injected into the bladder, can help reduce pain and improve symptoms more effectively than just the injections alone.

To be eligible for this trial, participants must be adult women aged between 18 and 75 who have been diagnosed with IC/BPS and currently experience significant pain (rated 5 or higher on a scale of 0 to 10). They should also have had a previous bladder procedure to assess their condition. However, there are some exclusions, such as a history of certain cancers, severe neurological conditions, or active urinary infections. Participants can expect to receive the PEMF device and to be monitored during the study to see how well the combination treatment works for their symptoms. This trial is not yet recruiting, but it represents an exciting step towards finding new ways to help those affected by these painful conditions.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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