Urinary Stress Incontinence and Urgency in Women With EMSELLA

Launched by SAN DIEGO SEXUAL MEDICINE · Mar 13, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for women experiencing stress urinary incontinence (SUI), urge incontinence (UI), and mixed urinary incontinence (MUI) using a technology called high-intensity focused electromagnetic (HIFEM) therapy. The goal is to assess not only how safe and effective this treatment is for managing incontinence symptoms but also to see if it has any positive effects on sexual health. The trial is currently recruiting women aged 21 to 80 who meet specific criteria, such as being sexually active and maintaining a consistent level of exercise.

Women interested in participating should be aware that they cannot have previously used the BTL EMSELLA device and must not have certain medical conditions that could affect their eligibility. If accepted into the study, participants will continue their regular activities and medications while attending scheduled visits for treatment. This trial aims to provide valuable information that could help improve the quality of life for women dealing with these types of urinary issues.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;
• • 2. Subject is female;
• • 3. Subject is aged 21-80 years;
• • 4. Subject has a body mass index (BMI) \< 37 kg/m2;
• • 5. Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID;
• • 6. Subject is currently sexually active and willing to continue sexual activity throughout the study;
• • 7. Subject is willing to continue level of core exercise currently being performed or not performed during the study (e.g. gym, Pilates, yoga);
• • 8. Subject is willing to maintain her current prescription and over the counter medications throughout the study without changing them;
• • 9. 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;
• • 3. Subject has clinically significant findings on physical examination;
• • 4. Subject has any chronic medical condition (e.g. neurologic disorder) or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
• • 5. Subject is unwilling to maintain current level of exercise throughout the study;
• • 6. Subject has been diagnosed with overactive bladder or interstitial cystitis;
• • 7. Subject experiences bladder pain or scores above 0 on the pain questions on the O'Leary/Sant Voiding and Pain Indices (ICSI/ICPI);
• • 8. Subject experiences pain with sexual activity
• • 9. Subject answers anything other than "almost never or never" or "a few times" on pain questions 17 or 18 of the Female Sexual Function Index (FSFI)
• • 10. Subject answers anything other than "very low or none at all" or "low" on pain questions 19 of the (FSFI)
• • 11. Subject planning to have surgery during the study;
• • 12. Subject has untreated malignancy;
• • 13. Subject is pregnant, planning to get pregnant or within 3 months postpartum;
• • 14. Subject has a pacemaker;
• • 15. Subject has and implant or IUD containing metal (e.g. copper 7);
• • 16. Subject has piercing between the waist and knees and is not willing to remove it before each treatment;
• • 17. Subject has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic drinks per week;
• • 18. Subject has received an investigational drug within 30 days prior to signing consent;
• • 19. Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.