Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

February 11, 2021 updated by: Elidah, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • Monroe, Connecticut, United States, 06468
        • Recruiting
        • Elidah
        • Contact:
          • Gloria Kolb, M.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Group A
Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A.
Device: ELITONE UUI
External electrical stimulation
Other Names:
  • ELITONE muscle stimulator
Active Comparator: Active Group B
Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B.
Device: ELITONE UUI
External electrical stimulation
Other Names:
  • ELITONE muscle stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy assessed by average number of urinary incontinence episodes per day
Time Frame: 6 weeks
6 weeks
Safety assessed by number of serious adverse events
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy assessed by change in Incontinence quality of life questionnaire (I-QOL)
Time Frame: 6 weeks
6 weeks
Efficacy assessed by reduction in average Pads used per day
Time Frame: 6 weeks
6 weeks
Efficacy assessed by reduction in average bathroom visits
Time Frame: 6 weeks
Day and night distinction
6 weeks
Efficacy assessed by reduction in average urge incontinence episodes
Time Frame: 6 weeks
Distinction with and without leaking
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elidah, Inc.

Investigators

  • Study Director: Gloria Kolb, M.S., Elidah, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2020

Primary Completion (Anticipated)

May 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

February 12, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR-1155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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