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Withdrawn NCT06013449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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06013449). StuddyBuddy aggregates publicly available trial information.