Using electromagnetic technology to treat urinary incontinence
High Intensity Focused Electromagnetic Field Device for Urinary Incontinence
This study is testing a new non-invasive treatment using electromagnetic technology to see if it can help people with urinary incontinence strengthen their pelvic floor muscles.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Boston Urogynecology Associates Academic / other |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT04031014 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of high intensity focused electromagnetic (HIFEM) technology to induce deep pelvic floor muscle contractions, equivalent to 11,200 Kegel exercises in just 28 minutes. The aim is to improve neuromuscular tone in patients suffering from stress urinary incontinence and urge incontinence. Participants will receive either active treatment with the BTL EMSELLA device or a sham treatment to assess the effectiveness of this non-invasive approach. The study seeks to provide an alternative for patients who may not be able or willing to undergo traditional pelvic floor physical therapy.
Who should consider this trial
Good fit: Ideal candidates include women over 18 with stress urinary incontinence, urge incontinence, or mixed urinary incontinence who are willing to maintain their current exercise regimen.
Not a fit: Patients with significant pelvic organ prolapse or those who have previously used the BTL EMSELLA device may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from urinary incontinence by providing a non-invasive alternative to traditional therapies.
How similar studies have performed: While the use of electromagnetic stimulation for pelvic floor disorders is a relatively novel approach, preliminary studies have shown promising results in similar applications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject provides written informed consent and HIPAA authorization before any study procedures are conducted 2. Age greater than 18 3. Subject has a body mass index (BMI) \< 37 kg/m2 4. Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID; 5. Subject is willing to continue level of core exercise currently being performed or not performed during the study (e.g. gym, Pilates, yoga); 6. Subject is willing to maintain her current prescription and over the counter medications throughout the study without changing them; 7. Subject agrees to comply with the study procedures and visits. Exclusion Criteria: 1. Subject has used the BTL EMSELLA device previously; 2. Subject has any significant pelvic organ prolapse; stage III or greater 3. Subject is unwilling to maintain current level of exercise throughout the study; 4. Subject planning to have surgery during the study; 5. Subject has untreated malignancy; 6. Subject is pregnant, planning to get pregnant or within 3 months postpartum; 7. Subject has a pacemaker; 8. Subject has and implant or IUD containing metal; 9. Subject has piercing between the waist and knees and is not willing to remove it before each treatment; 10. Subject is using a pessary or other anti-incontinence device 11. Subject has implanted defibrillator, implanted neurostimulator 12. Subject has metal implants 13. Subject has a drug pump
Where this trial is running
Cambridge, Massachusetts
- Boston Urogynecology Associates — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Kathy Rogers
- Email: krogers@mah.harvard.edu
- Phone: 617-354-5452
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.