NCT03782116

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

January 13, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

August 16, 2018

Results QC Date

January 28, 2022

Last Update Submit

January 7, 2025

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes

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

    12 weeks

Secondary Outcomes (3)

  • Efficacy Assessed by Percent Reduction in Average Pad Weight

    12 weeks

  • Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL)

    12 weeks

  • Pads Per Day

    12 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz)

Device: Transcutaneous electrical stimulation (Elitone)

Control

SHAM COMPARATOR

Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles.

Device: Transcutaneous electrical stimulation (Elitone)

Interventions

Transcutaneous electrical stimulation (Elitone)DEVICE

Transcutaneous perineal area electrical stimulation

Also known as: Elitone
ControlTreatment

Eligibility Criteria

Age21 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsYes must identify as female
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Predominant Mild-moderate stress incontinence symptoms as determined by self-reported typical number of accidents of 1 per 24 hours or more.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide At-Home study

Monroe, Connecticut, 06468, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Results Point of Contact

Title
Director of Clinical Trials
Organization
Elidah, Inc.
customercare@elitone.com
978.435.4324

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The device looks identical, but the waveform is different. Randomization, programming and recording of which waveform is done by a third party separate from those listed above.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2018

First Posted

December 20, 2018

Study Start

September 1, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

January 13, 2025

Results First Posted

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)