N/A N=87 Randomized Quadruple-blind Treatment

Stress Incontinence Trial With Elitone Device

Stress Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT03782116 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes — 52.8; 7.9 percent reduction in leaks/day

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transcutaneous electrical stimulation (Elitone) (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: Female
Sponsor: Elidah, Inc.
Primary completion: Mar 2019

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.