Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations
WithdrawnNot applicableNCT06013449
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Investigation of the Effect of Simultaneous Pulsed Electromagnetic Field (PEMF) and Intravesical Heparin - Bupivacaine Cocktail Instillation for the Symptomatic Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
- Conditions
- Interstitial Cystitis
- Chronic Interstitial Cystitis
- Bladder Pain Syndrome
- Interventions
- Device: Pulsed Electromagnetic Field (PEMF) Device
- Device: Sham Pulsed Electromagnetic Feild (PEMF) Device
- Sponsor
- Wake Forest University Health Sciences
- Start date
- 2026-05
- Primary completion
- 2026-05-27
- Sex
- Female
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06013449