Status:
COMPLETED
Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women
Lead Sponsor:
Elidah, Inc.
Conditions:
Urge Incontinence
Eligibility:
FEMALE
21-80 years
Phase:
NA
Brief Summary
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 fl...
Detailed Description
The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence in women. The aim of the device is to stimulate the ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
November 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04752709
Start Date
November 19 2020
End Date
September 30 2021
Last Update
December 30 2024
Active Locations (1)
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1
Elidah
Monroe, Connecticut, United States, 06468