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Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

NCT ID: NCT04752709

Last Updated: 2024-12-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-19

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Urge Incontinence

Keywords

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incontinence bladder urge urgency stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized between two active groups
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Device looks identical. A third person masks which software is coded.

Study Groups

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Active Group A

Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A.

Group Type EXPERIMENTAL

ELITONE UUI

Intervention Type DEVICE

External electrical stimulation

Active Group B

Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B.

Group Type ACTIVE_COMPARATOR

ELITONE UUI

Intervention Type DEVICE

External electrical stimulation

Interventions

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ELITONE UUI

External electrical stimulation

Intervention Type DEVICE

Other Intervention Names

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ELITONE muscle stimulator

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Elidah, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gloria Kolb, M.S.

Role: STUDY_DIRECTOR

Elidah, Inc.

Locations

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Elidah

Monroe, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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TR-1155

Identifier Type: -

Identifier Source: org_study_id