Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

Urge Incontinence Clinical Trial

Official title:

Clinical Study to Evaluate the Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04752709
• Other study ID #: TR-1155
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Enuresis
• Urge Incontinence
• Urinary Incontinence
• Urinary Incontinence, Urge

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