Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

Completed · Not applicable

Conditions studied: Urge Incontinence

In brief

The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence. The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence.

Key facts

Study ID

NCT04752709

Run by

Elidah, Inc.

People needed

82

Starts

2020-11-19

Expected to finish

2021-09-30

Last updated by the study team

2024-12-30

Who can join

Age: 21 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Predominant urge urinary incontinence as determined by responses to a series of three standard questions from the King's Health Questionnaire; specifically:
• An affirmative response to "Is it very difficult to control when you have a strong urge to urinate?",
• An affirmative or negative response to "Do you lose urine with physical activities such as coughing, sneezing, running?",
• And, if an affirmative response to the second question, an affirmative response to "Are more of your incontinence episodes due to a strong urge to urinate than to abdominal pressure such as sneezing?"
• Mild-moderate incontinence symptoms as determined by self-reported typical number of accidents of 1 or more per 24 hours. Symptom severity is later verified with data from the Daily Log (See 5.4)

You may not qualify if…

• Less than 1 incontinence accident (leak) per day*
• Severe incontinence as determined by self-reported >5 accidents per day
• Currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks
• Vaginal or pelvic surgery within previous 6 months
• Severe Obesity as defined by BMI >= 35
• Change in incontinence medication type or dosing within the last 3 months.
• History or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence
• Pelvic pain/painful bladder syndrome
• Active urinary tract infection (UTI) or history of recurrent UTIs (more than three in a year), or recurrent vaginitis (bacterial/fungal)
• Tissues protruding outside the vagina at rest
• Presence of incontinence-associated dermatitis or other perineal skin disorders or lesions,
• Complete denervation of the pelvic floor
• Conductive inter-uterine devise (IUD/Coil) or metal implants in the abdominal or pelvic area, including the hip and lumbar spine,
• Chronic coughing
• Previous use of Interstim device or Botox for UI
• Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
• Cancer, epilepsy or cognitive dysfunction
• Underlying neurologic/neuromuscular disorder
• Impaired decision making, suicidal thoughts, or drug/alcohol dependence
• Lacks capacity to consent for themselves.

Where it is running

• Elidah — Monroe, Connecticut, United States

Full record on ClinicalTrials.gov

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