NCT03782116

Stress Incontinence Trial With Elitone Device

Randomized Controlled Study of Efficacy of Elitone Device For the Treatment of Mild-Moderate Stress Urinary Incontinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Elidah, Inc. · Industry
• Sex: Female
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled study in which subjects are assigned to either a treatment group or a control (sham) group. Pre- and post-study outcome measures evaluate the change in incontinence episodes on women with mild-moderate stress urinary incontinence.

Detailed description

The Elitone device delivers electrical muscle stimulation to pelvic floor muscles through a disposable surface electrode shaped to fit the perineal region. In typical use women self-administer treatment 20 minutes per day, 5x per week, for 6-12 weeks. Elidah is initiating a prospective, randomized clinical study to demonstrate device efficacy. The study expands a similar pilot to 60 subjects, adds a control arm (sham device) and includes additional outcome measures. Like the earlier study, subjects will self-administer treatment over multiple weeks while maintaining daily logs of their treatment and incontinence symptoms. This is a home-use study, which does not require clinic visits. Accordingly, this allows subject recruitment from across US.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Transcutaneous electrical stimulation (Elitone)	Transcutaneous perineal area electrical stimulation

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-03-31
• Completion: 2019-03-31
• First posted: 2018-12-20
• Last updated: 2025-01-13
• Results posted: 2025-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study