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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

About this trial

This is an interventional treatment trial for Urge Incontinence focused on measuring incontinence, bladder, urge, urgency, stimulation

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

NCT ID

NCT04752709

First Posted

January 22, 2021

Last Updated

February 11, 2021

Sponsor

Elidah, Inc.

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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

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

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

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

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Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

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