NCT03782116

Stress Incontinence Trial With Elitone Device

Completed NA Results posted Last updated 13 January 2025

What this trial tests

NA trial testing Transcutaneous electrical stimulation (Elitone) in Stress Urinary Incontinence in 87 participants. Completed in 31 March 2019.

Timeline

1 September 2018

Primary endpoint
31 March 2019

31 March 2019

Quick facts

Lead sponsor	Elidah, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	87
Start date	1 September 2018
Primary completion	31 March 2019
Estimated completion	31 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Transcutaneous electrical stimulation (Elitone)

Conditions studied

• Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →

Sponsor

Elidah, Inc.

Who can join

Adults 21 to 75, female only, with Stress Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes Primary · 12 weeks

The percent reduction in average number of urinary incontinence episodes over 12 weeks.

Group	Value	95% CI
Treatment	52.8	± 36.3
Control	7.9	± 55.9

Efficacy Assessed by Percent Reduction in Average Pad Weight Secondary · 12 weeks

The percent reduction of pad weight in a day over the 12 weeks.

Group	Value	95% CI
Treatment	38.3	± 62.4
Control	25.3	± 48.8

Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL) Secondary · 12 weeks

The efficacy assessed by change in Incontinence quality of life questionnaire (I-QOL). It comprises 22 questions, to which the subject provides a numeric response on a 1-5 scale. 1 = not at all , 2 = a little, 3 = moderately, 4 = quite a bit and 5 = extremely. The score is the sum of the numeric responses, which can range from 22 to 110. The lower the value the less times it happens and the better outcome.

Group	Value	95% CI
Treatment	20.8	± 20.8
Control	10.3	± 21.8

Pads Per Day Secondary · 12 weeks

Reduction of number of pads used per day

Group	Value	95% CI
Treatment	35.0	± 34.1
Control	8.2	± 59.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Duration of the 12-week study. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment

Serious: 0/35 (0%)

Deaths: 0/35

Control

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (1 terms — click to expand)

Reaction	System	Treatment	Control
Transient muscle pain	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT03782116 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.