N/A
Completed N=87
Stress Incontinence Trial With Elitone Device
Source: ClinicalTrials.gov NCT03782116 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes — 52.8; 7.9 percent reduction in leaks/day
Summary
This is a randomized controlled study in which subjects are assigned to either a treatment group or a control (sham) group. Pre- and post-study outcome measures evaluate the change in incontinence episodes on women with mild-moderate stress urinary incontinence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes |
52.8; 7.9 | — |
| SECONDARY Efficacy Assessed by Percent Reduction in Average Pad Weight |
38.3; 25.3 | — |
| SECONDARY Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL) |
20.8; 10.3 | — |
| SECONDARY Pads Per Day |
35.0; 8.2 | — |
Eligibility Criteria
Inclusion Criteria
Predominant Mild-moderate stress incontinence symptoms as determined by self-reported typical number of accidents of 1 per 24 hours or more.
Exclusion Criteria
- Severe incontinence as determined by self-reported >5 accidents in 24-hr period
- Currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks
- Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
- Cancer, epilepsy or cognitive dysfunction
- Vaginal or pelvic surgery within previous 6 months
- Complete denervation of the pelvic floor
- History or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence
- Active urinary tract infection (UTI) or history of recurrent UTIs (more than three in a year)
- Recurrent vaginitis (bacterial/fungal)
- Pelvic pain/painful bladder syndrome
- Underlying neurologic/neuromuscular disorder
- Severe Obesity as defined by BMI >= 35
- Chronic coughing
- Impaired decision making, drug or alcohol dependence, or suicidal thoughts.
- Anyone who lacks the capacity to consent for themselves or who requires a legal representative to give informed consent.
Data sourced from ClinicalTrials.gov (NCT03782116). 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.