Stress Incontinence Trial With Elitone Device

Completed · Not applicable

Conditions studied: Stress Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT03782116

Run by

Elidah, Inc.

People needed

87

Starts

2018-09-01

Expected to finish

2019-03-31

Last updated by the study team

2025-01-13

Who can join

Age: 21 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Predominant Mild-moderate stress incontinence symptoms as determined by self-reported typical number of accidents of 1 per 24 hours or more.

You may not qualify if…

• Severe incontinence as determined by self-reported >5 accidents in 24-hr period
• Currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks
• Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
• Cancer, epilepsy or cognitive dysfunction
• Vaginal or pelvic surgery within previous 6 months
• Complete denervation of the pelvic floor
• History or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence
• Active urinary tract infection (UTI) or history of recurrent UTIs (more than three in a year)
• Recurrent vaginitis (bacterial/fungal)
• Pelvic pain/painful bladder syndrome
• Underlying neurologic/neuromuscular disorder
• Severe Obesity as defined by BMI >= 35
• Chronic coughing
• Impaired decision making, drug or alcohol dependence, or suicidal thoughts.
• Anyone who lacks the capacity to consent for themselves or who requires a legal representative to give informed consent.

Where it is running

• Nationwide At-Home study — Monroe, Connecticut, United States

Full record on ClinicalTrials.gov

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