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Withdrawn
NCT06013449
Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations
Conditions: Interstitial Cystitis, Chronic Interstitial Cystitis, Bladder Pain Syndrome
Sex: Female
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Sponsor: Wake Forest University Health Sciences
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.
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
Source: ClinicalTrials.gov (NCT06013449). StuddyBuddy aggregates publicly available trial information.