Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

NCT04752709 | Completed Results DMC FDA Device

• 1 other identifier: TR-1155
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Urge Incontinence

Keywords

incontinence; bladder; urge; urgency; stimulation

Outcome Measures

Primary Outcomes (2)

• Change in Average Number of Urinary Incontinence Episodes Per Day

  The efficacy of a treatment for urinary incontinence measures how much the treatment changed urinary incontinence leakage from the beginning to the end of the 6 week period.

  6 weeks

• Safety Assessed by Number of Serious Adverse Events

  Any serious adverse events recorded during the trial.

  6 weeks

Secondary Outcomes (3)

• Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL)

  6 weeks

• Efficacy Assessed by Reduction in Average Pads Used Per Day

  6 weeks

• Efficacy Assessed by Reduction in Average Bathroom Visits

  6 weeks

Study Arms (2)

Active Group A

EXPERIMENTAL

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

Device: ELITONE UUI

Active Group B

ACTIVE COMPARATOR

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

Device: ELITONE UUI

Interventions

ELITONE UUI DEVICE

External electrical stimulation

Also known as: ELITONE muscle stimulator

Active Group A; Active Group B

Eligibility Criteria

• Age: 21 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Elidah, Inc.: lead

Study Sites (1)

Elidah

Monroe, Connecticut, 06468, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Elidah, Inc.

customercare@elitone.com

978.435.4324

Study Officials

• Gloria Kolb, M.S.

  Elidah, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Device looks identical. A third person masks which software is coded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized between two active groups

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 12, 2021
• Study Start: November 19, 2020
• Primary Completion: May 30, 2021
• Study Completion: September 30, 2021
• Last Updated: December 30, 2024
• Results First Posted: December 30, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)