High Intensity Focused Electromagnetic Field Device for Urinary Incontinence

Launched by BOSTON UROGYNECOLOGY ASSOCIATES · Jul 23, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for women who experience urinary incontinence, which is when you have trouble controlling your bladder. The treatment uses a special device that sends focused electromagnetic energy to help strengthen pelvic floor muscles. This is similar to doing 11,200 Kegel exercises in just 28 minutes. The goal is to improve muscle tone and reduce symptoms of both stress urinary incontinence (leakage during activities like coughing or exercising) and urge incontinence (a sudden, strong need to urinate).

To participate, you need to be a woman over 18 years old with a body mass index (BMI) under 37. You should also be experiencing stress or urge urinary incontinence and be willing to maintain your current exercise routine during the study. If you meet these criteria, you can expect to attend several clinic visits where you'll receive this new treatment. It’s important to know that some conditions, like having a pacemaker or certain metal implants, may prevent you from participating in this trial. If you're looking for ways to manage urinary incontinence, this study might be a good opportunity to explore a promising treatment option.

Gender

FEMALE

Eligibility 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