NCT03877640

Urinary Stress Incontinence and Urgency in Women With EMSELLA

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: San Diego Sexual Medicine · Academic / Other
• Sex: Female
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this prospective study is to examine the safety and efficacy of high intensity focused electromagnetic (HIFEM) technology for the treatment of women with stress urinary incontinence (SUI), urge incontinence (UI) and mixed stress urinary and urge incontinence (MUI), looking at any potential sexual health benefits that may be concomitantly achieved from this treatment.

Detailed description

This is a blinded study to be conducted at San Diego Sexual Medicine in San Diego, CA. Participants meeting inclusion and exclusion criteria will receive one treatment cycle of active treatment or sham. The device will be equipped with 3 protocols in addition to the standard protocol, two of which are identical to the standard protocol (for active treatment) and one of which does not deliver HIFEM (for sham treatment). The active treatment arm consists of 6 treatments, 2 per week, with at least one day in between. Follow-up visits will occur at 4 weeks and 12 weeks after the last treatment. Unblinding will take place at the 12 week follow up visit, and subjects assigned to the sham arm will be crossed over to active treatment, beginning their first treatment on that day, completing 6 treatments and 2 follow up visits. Once unblinded the subject will be treated with the standard protocol of the device. After the informed consent is signed, and inclusion and exclusion criteria completed, participants will complete validated questionnaires and undergo a baseline physical therapy assessment of pelvic floor muscle strength.

Conditions

• Stress Urinary Incontinence
• Urge Incontinence

Interventions

Type	Name	Description
DEVICE	BTL EMSELLA	High intensity focused electromagnetic (HIFEM) technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes.

Timeline

• Start date: 2019-01-11
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2019-03-18
• Last updated: 2023-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study