Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women
Primary Purpose
Urge Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ELITONE UUI
Sponsored by
About this trial
This is an interventional treatment trial for Urge Incontinence focused on measuring incontinence, bladder, urge, urgency, stimulation
Eligibility Criteria
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.
Sites / Locations
- ElidahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active Group A
Active Group B
Arm Description
Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A.
Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B.
Outcomes
Primary Outcome Measures
Efficacy assessed by average number of urinary incontinence episodes per day
Safety assessed by number of serious adverse events
Secondary Outcome Measures
Efficacy assessed by change in Incontinence quality of life questionnaire (I-QOL)
Efficacy assessed by reduction in average Pads used per day
Efficacy assessed by reduction in average bathroom visits
Day and night distinction
Efficacy assessed by reduction in average urge incontinence episodes
Distinction with and without leaking
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04752709
Brief Title
Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women
Official Title
Clinical Study to Evaluate the Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elidah, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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 floor muscles and surrounding structures to improve urinary incontinence.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urge Incontinence
Keywords
incontinence, bladder, urge, urgency, stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized between two active groups
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Device looks identical. A third person masks which software is coded.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Group A
Arm Type
Experimental
Arm Description
Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A.
Arm Title
Active Group B
Arm Type
Active Comparator
Arm Description
Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B.
Intervention Type
Device
Intervention Name(s)
ELITONE UUI
Other Intervention Name(s)
ELITONE muscle stimulator
Intervention Description
External electrical stimulation
Primary Outcome Measure Information:
Title
Efficacy assessed by average number of urinary incontinence episodes per day
Time Frame
6 weeks
Title
Safety assessed by number of serious adverse events
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Efficacy assessed by change in Incontinence quality of life questionnaire (I-QOL)
Time Frame
6 weeks
Title
Efficacy assessed by reduction in average Pads used per day
Time Frame
6 weeks
Title
Efficacy assessed by reduction in average bathroom visits
Description
Day and night distinction
Time Frame
6 weeks
Title
Efficacy assessed by reduction in average urge incontinence episodes
Description
Distinction with and without leaking
Time Frame
6 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gloria Kolb, M.S.
Phone
203-304-9414
Email
director@elitonestudy.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria Kolb, M.S.
Organizational Affiliation
Elidah, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Elidah
City
Monroe
State/Province
Connecticut
ZIP/Postal Code
06468
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gloria Kolb, M.S.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women
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