Treatment for urinary incontinence in women using EMSELLA technology

A Double-Blind, Sham Controlled Prospective Pilot Study of Urinary Stress Incontinence and Urgency in Women After 6 Treatments With HIFEM Technology (BTL EMSELLA)

This study is testing a new technology to see if it can help women with different types of urinary incontinence feel better and possibly improve their sexual health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 21 Years to 80 Years
• Sex: Female
• Sponsor: San Diego Sexual Medicine (Academic / other)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT03877640 on ClinicalTrials.gov

What this trial studies

This prospective study aims to evaluate the safety and efficacy of high intensity focused electromagnetic (HIFEM) technology for treating women with stress urinary incontinence, urge incontinence, and mixed urinary incontinence. Conducted at San Diego Sexual Medicine, participants will be randomly assigned to receive either active treatment or a sham procedure, with follow-up assessments at 4 and 12 weeks post-treatment. The study will also explore potential sexual health benefits associated with the treatment. Participants will undergo baseline assessments and complete validated questionnaires throughout the study.

Who should consider this trial

Good fit: Ideal candidates are women aged 21-80 with stress urinary incontinence, urge incontinence, or mixed urinary incontinence who are currently sexually active.

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 urinary incontinence symptoms and enhance sexual health for women affected by these conditions.

How similar studies have performed: Other studies using similar HIFEM technology have shown promising results, indicating potential for success in this approach.

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.

Where this trial is running

San Diego, California

• San Diego Sexual Medicine — San Diego, California, United States (Recruiting)

Study contacts

• Study coordinator: Clinical Research Manager

Conditions Stress Urinary Incontinence; Urge Incontinence; incontinence; stress urgency incontinence; urge incontinence; EMSELLA