Trial Outcomes & Findings for Stress Incontinence Trial With Elitone Device (NCT NCT03782116)

NCT ID: NCT03782116

Last Updated: 2025-01-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 87 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2025-01-13

Participant Flow

Participant milestones

Measure	Treatment Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz) Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation	Control Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles. Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation
Completed Intervetion STARTED	57	30
Completed Intervetion COMPLETED	40	18
Completed Intervetion NOT COMPLETED	17	12
Included in Analysis STARTED	40	18
Included in Analysis COMPLETED	35	13
Included in Analysis NOT COMPLETED	5	5

Reasons for withdrawal

Measure	Treatment Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz) Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation	Control Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles. Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation
Completed Intervetion Lost to Follow-up	11	7
Completed Intervetion Withdrawal by Subject	6	5
Included in Analysis Protocol Violation	5	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Treatment n=35 Participants Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz) Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation	Control n=13 Participants Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles. Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation	Total n=48 Participants Total of all reporting groups
Age, Continuous	48.7 years STANDARD_DEVIATION 13.3 • n=35 Participants	44.7 years STANDARD_DEVIATION 7.0 • n=13 Participants	47.6 years STANDARD_DEVIATION 12.0 • n=48 Participants
Sex: Female, Male Female	35 Participants n=35 Participants	13 Participants n=13 Participants	48 Participants n=48 Participants
Sex: Female, Male Male	0 Participants n=35 Participants	0 Participants n=13 Participants	0 Participants n=48 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	35 participants n=35 Participants	13 participants n=13 Participants	48 participants n=48 Participants
Stress incontinence leaks/day	2.81 leaks/day STANDARD_DEVIATION 1.01 • n=35 Participants	2.65 leaks/day STANDARD_DEVIATION 1.17 • n=13 Participants	2.76 leaks/day STANDARD_DEVIATION 1.05 • n=48 Participants

PRIMARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Treatment n=35 Participants Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz) Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation	Control n=13 Participants Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles. Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation
Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes	52.8 percent reduction in leaks/day Standard Deviation 36.3	7.9 percent reduction in leaks/day Standard Deviation 55.9

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Treatment n=35 Participants Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz) Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation	Control n=13 Participants Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles. Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation
Efficacy Assessed by Percent Reduction in Average Pad Weight	38.3 percentage reduction in pad weight Standard Deviation 62.4	25.3 percentage reduction in pad weight Standard Deviation 48.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=35 Participants Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz) Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation	Control n=13 Participants Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles. Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation
Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL)	20.8 Change of score on a scale Standard Deviation 20.8	10.3 Change of score on a scale Standard Deviation 21.8

SECONDARY outcome

Timeframe: 12 weeks

Reduction of number of pads used per day

Outcome measures

Measure	Treatment n=35 Participants Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz) Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation	Control n=13 Participants Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles. Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation
Pads Per Day	35.0 percentage reduction Standard Deviation 34.1	8.2 percentage reduction Standard Deviation 59.9

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment n=35 participants at risk Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz) Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation	Control n=13 participants at risk Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles. Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation
Musculoskeletal and connective tissue disorders Transient muscle pain	2.9% 1/35 • Number of events 1 • Duration of the 12-week study External elextrical muscle stimulation is a non-significant risk treatment. Accordingly, serious adverse events are not anticipated for a study of this size.	0.00% 0/13 • Duration of the 12-week study External elextrical muscle stimulation is a non-significant risk treatment. Accordingly, serious adverse events are not anticipated for a study of this size.

Additional Information

Director of Clinical Trials

Elidah, Inc.

Phone: 978.435.4324

Email: customercare@elitone.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place