Investigation of PEMF Therapy for Female Patients With IC/BPS
The purpose of this study is to gather information about the safety and effectiveness of the non-pharmacological (non-drug), non-invasive treatment known as low-frequency pulsed electromagnetic field (PEMF) therapy. The study team will distribute the PEMF device to female adults with Interstitial Cystitis/Bladder Pain
| Condition(s) | Interstitial Cystitis, Chronic Interstitial Cystitis, Bladder Pain Syndrome |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The purpose of this study is to gather information about the safety and effectiveness of the non-pharmacological (non-drug), non-invasive treatment known as low-frequency pulsed electromagnetic field (PEMF) therapy. The study team will distribute the PEMF device to female adults with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) to measure its ability to decrease bladder and pelvic pain as well as other urinary symptoms associated with IC/BPS. There are two sequential Aims in this study and subjects will be recruited to participate in only one Aim. In both Aims, data will be collected at baseline/enrollment, 4-weeks after using PEMF therapy, and 8, 12, and 16 weeks post-enrollment. |
| Who can participate | Inclusion Criteria: * Previously established clinical diagnosis of IC/PS * Current numeric rating scale (NRS) score of ≥ 6 * History of cystoscopy with hydrodistension with bladder capacity determination under anesthesia * No cognitive deficits Exclusion Criteria: * History of bladder, ovarian, vaginal cancer * History of urethral diverticulum * History of radiation cystitis * History of spinal cord injury or spina bifida * History of Parkinson's disease, multiple sclerosis, or stroke * Current placement of a pacemaker or metal prosthesis * Active urinary tract infection * BMI \> 40 * Residual urine of \> 100cc * Current pregnant |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Lead sponsor | Wake Forest University Health Sciences |
| Locations | Winston-Salem, North Carolina, United States |
| Start date | 2022-08-29 |
| NCT ID | NCT05149573 |
| Official listing | https://clinicaltrials.gov/study/NCT05149573 |