Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

Elidah, Inc.

Status: Completed

Conditions: Urge Incontinence

Treatments: Device: ELITONE UUI

Study type: Interventional

Funder types: Industry

Identifiers

NCT04752709

TR-1155

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: Female

Ages: 21 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups

Active Group A

Experimental group

Description:

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

Treatment:

Device: ELITONE UUI

Active Group B

Active Comparator group

Description:

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

Treatment:

Device: ELITONE UUI