Clinical trial NCT04752709: 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
Overall status: COMPLETED
Phase: NA
Conditions: Urge Incontinence
Keywords: incontinence
bladder
urge
urgency
stimulation
Lead sponsor: Elidah, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-12
Enrollment: 82
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized between two active groups
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Average Number of Urinary Incontinence Episodes Per Day
timeFrame: 6 weeks
measure: Safety Assessed by Number of Serious Adverse Events
timeFrame: 6 weeks
Secondary outcomes:
measure: Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL)
timeFrame: 6 weeks
measure: Efficacy Assessed by Reduction in Average Pads Used Per Day
timeFrame: 6 weeks
measure: Efficacy Assessed by Reduction in Average Bathroom Visits
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Monroe
country: United States
facility: Elidah
state: Connecticut
Study officials:
affiliation: Elidah, Inc.
name: Gloria Kolb, M.S.
role: STUDY_DIRECTOR
References: