N/A
Completed N=82
Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women
Urge Incontinence
Source: ClinicalTrials.gov NCT04752709 ↗
Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Change in Average Number of Urinary Incontinence Episodes Per Day — 69.6; 66.1 percentage change — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average Number of Urinary Incontinence Episodes Per Day |
69.6; 66.1 | <0.0001 sig |
| PRIMARY Safety Assessed by Number of Serious Adverse Events |
0; 0 | — |
| SECONDARY Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL) |
-26.6; -21.8 | — |
| SECONDARY Efficacy Assessed by Reduction in Average Pads Used Per Day |
27.8; 36.4 | — |
| SECONDARY Efficacy Assessed by Reduction in Average Bathroom Visits |
5.9; 0.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04752709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.