Trial Outcomes & Findings for Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women (NCT NCT04752709)

Results Overview

The efficacy of a treatment for urinary incontinence measures how much the treatment changed urinary incontinence leakage from the beginning to the end of the 6 week period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

82 participants

Primary outcome timeframe

6 weeks

Results posted on

2024-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	Active Group A Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A (urge only for 6 seconds/cycle). ELITONE UUI: External electrical stimulation	Active Group B Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B (urge and stress) ELITONE UUI: External electrical stimulation
Overall Study STARTED	26	56
Overall Study COMPLETED	17	34
Overall Study NOT COMPLETED	9	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Group A n=17 Participants Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A (urge only for 6 seconds/cycle). ELITONE UUI: External electrical stimulation	Active Group B n=34 Participants Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B (urge and stress) ELITONE UUI: External electrical stimulation	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=17 Participants	0 Participants n=34 Participants	0 Participants n=51 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=17 Participants	23 Participants n=34 Participants	36 Participants n=51 Participants
Age, Categorical >=65 years	4 Participants n=17 Participants	11 Participants n=34 Participants	15 Participants n=51 Participants
Age, Continuous	53.0 years STANDARD_DEVIATION 13.8 • n=17 Participants	57.8 years STANDARD_DEVIATION 12.7 • n=34 Participants	56.2 years STANDARD_DEVIATION 13.1 • n=51 Participants
Sex: Female, Male Female	17 Participants n=17 Participants	34 Participants n=34 Participants	51 Participants n=51 Participants
Sex: Female, Male Male	0 Participants n=17 Participants	0 Participants n=34 Participants	0 Participants n=51 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	17 participants n=17 Participants	34 participants n=34 Participants	51 participants n=51 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Total of 82 participants, but only 51 completed the trial.

The efficacy of a treatment for urinary incontinence measures how much the treatment changed urinary incontinence leakage from the beginning to the end of the 6 week period.

Outcome measures

Outcome measures
Measure	Active Group A n=17 Participants Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A (urge only for 6 seconds/cycle). ELITONE UUI: External electrical stimulation	Active Group B n=34 Participants Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B (urge and stress) ELITONE UUI: External electrical stimulation
Change in Average Number of Urinary Incontinence Episodes Per Day	69.6 percentage change Standard Deviation 30.9	66.1 percentage change Standard Deviation 28.7

PRIMARY outcome

Timeframe: 6 weeks

Population: There were no adverse events for any participants

Any serious adverse events recorded during the trial.

Outcome measures

Outcome measures
Measure	Active Group A n=17 Participants Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A (urge only for 6 seconds/cycle). ELITONE UUI: External electrical stimulation	Active Group B n=34 Participants Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B (urge and stress) ELITONE UUI: External electrical stimulation
Safety Assessed by Number of Serious Adverse Events	0 serious adverse events Standard Deviation 0	0 serious adverse events Standard Deviation 0

SECONDARY outcome

Timeframe: 6 weeks

The efficacy assessed by change in Incontinence quality of life questionnaire (I-QOL). The scale is as follows: 1 = not at all , 2 = a little, 3 = moderately, 4 = quite a bit and 5 = extremely. The lower the value the less times it happens and the better outcome. A larger results indicate a higher change in I-QOL from beginning to end of trial. The minimum score total is 22 and maximum total score is 110.

Outcome measures

Outcome measures
Measure	Active Group A n=17 Participants Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A (urge only for 6 seconds/cycle). ELITONE UUI: External electrical stimulation	Active Group B n=34 Participants Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B (urge and stress) ELITONE UUI: External electrical stimulation
Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL)	-26.6 change of score on a scale Standard Deviation 20.2	-21.8 change of score on a scale Standard Deviation 15.9

SECONDARY outcome

Timeframe: 6 weeks

Efficacy Assessed by Reduction in Average Pads used per day over the 6 week period.

Outcome measures

Outcome measures
Measure	Active Group A n=17 Participants Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A (urge only for 6 seconds/cycle). ELITONE UUI: External electrical stimulation	Active Group B n=15 Participants Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B (urge and stress) ELITONE UUI: External electrical stimulation
Efficacy Assessed by Reduction in Average Pads Used Per Day	27.8 percentage of change Standard Deviation 57.4	36.4 percentage of change Standard Deviation 33.5

SECONDARY outcome

Timeframe: 6 weeks

The efficacy assessed by average bathroom visits during the day and night.

Outcome measures

Outcome measures
Measure	Active Group A n=17 Participants Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A (urge only for 6 seconds/cycle). ELITONE UUI: External electrical stimulation	Active Group B n=34 Participants Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B (urge and stress) ELITONE UUI: External electrical stimulation
Efficacy Assessed by Reduction in Average Bathroom Visits	5.9 percentage of change Standard Deviation 29.5	0.5 percentage of change Standard Deviation 26.0

Adverse Events

Active Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Trials

Elidah, Inc.

Phone: 978.435.4324

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place