PEMF therapy for women with bladder pain syndrome
Investigation of Non-Invasive Pulsed Electromagnetic Field (PEMF) Therapy for Female Patients With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
NA · Wake Forest University Health Sciences · NCT05149573
This study is testing if a new non-invasive treatment using pulsed electromagnetic fields can help women with bladder pain syndrome feel less pain and improve their urinary symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05149573 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of low-frequency pulsed electromagnetic field (PEMF) therapy as a non-invasive treatment for female patients suffering from Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Participants will receive a PEMF device to assess its impact on reducing bladder and pelvic pain, as well as other urinary symptoms associated with IC/BPS. The study will collect data at various intervals, including baseline, 4 weeks, and up to 16 weeks post-enrollment, to evaluate the therapy's effectiveness over time. The research aims to address the chronic and often debilitating symptoms of IC/BPS, which can significantly impair quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are female adults with a clinical diagnosis of IC/BPS and a pain score of 6 or higher on a numeric rating scale.
Not a fit: Patients with a history of certain cancers, neurological disorders, or those currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a non-drug option for managing chronic bladder pain and improve the quality of life for patients with IC/BPS.
How similar studies have performed: While PEMF therapy is a relatively novel approach for treating IC/BPS, similar non-invasive therapies have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Stephen J Walker, PhD — Wake Forest University Health Sciences
- Study coordinator: Stephen J Walker, PhD
- Email: Stephen.J.Walker@advocatehealth.org
- Phone: 336-713-7272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Interstitial Cystitis, Chronic Interstitial Cystitis, Bladder Pain Syndrome, interstitial cystitis, bladder pain syndrome, painful bladder syndrome, painful bladder, bladder pain