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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04752709
Other study ID # TR-1155
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 19, 2020
Est. completion date June 30, 2021

Study information

Verified date February 2021
Source Elidah, Inc.
Contact Gloria Kolb, M.S.
Phone 203-304-9414
Email director@elitonestudy.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 floor muscles and surrounding structures to improve urinary incontinence.


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 pelvic floor muscles and surrounding structures to improve urinary incontinence. This is a randomized prospective controlled study of two active groups with a stimulation frequency difference between the groups.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 30, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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.

Study Design


Intervention

Device:
ELITONE UUI
External electrical stimulation

Locations

Country Name City State
United States Elidah Monroe Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Elidah, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy assessed by average number of urinary incontinence episodes per day 6 weeks
Primary Safety assessed by number of serious adverse events 6 weeks
Secondary Efficacy assessed by change in Incontinence quality of life questionnaire (I-QOL) 6 weeks
Secondary Efficacy assessed by reduction in average Pads used per day 6 weeks
Secondary Efficacy assessed by reduction in average bathroom visits Day and night distinction 6 weeks
Secondary Efficacy assessed by reduction in average urge incontinence episodes Distinction with and without leaking 6 weeks
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