Urge IncontinenceNCT04752709
Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women
A study testing ELITONE UUI in people with Urge Incontinence, run by Elidah, Inc. at 1 site in United States.
Trial summary
The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence. The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Urge Incontinence
- What is being tested?
- ELITONE UUI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Predominant urge urinary incontinence as determined by responses to a series of three standard questions from the King's Health Questionnaire; specifically:
- An affirmative response to "Is it very difficult to control when you have a strong urge to urinate?",
- An affirmative or negative response to "Do you lose urine with physical activities such as coughing, sneezing, running?",
- And, if an affirmative response to the second question, an affirmative response to "Are more of your incontinence episodes due to a strong urge to urinate than to abdominal pressure such as sneezing?"
- Mild-moderate incontinence symptoms as determined by self-reported typical number of accidents of 1 or more per 24 hours. Symptom severity is later verified with data from the Daily Log (See 5.4)
Who cannot join
- Less than 1 incontinence accident (leak) per day*
- Severe incontinence as determined by self-reported >5 accidents per day
- Currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks
- Vaginal or pelvic surgery within previous 6 months
- Severe Obesity as defined by BMI >= 35
- Change in incontinence medication type or dosing within the last 3 months.
Show all 20Show fewer
- History or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence
- Pelvic pain/painful bladder syndrome
- Active urinary tract infection (UTI) or history of recurrent UTIs (more than three in a year), or recurrent vaginitis (bacterial/fungal)
- Tissues protruding outside the vagina at rest
- Presence of incontinence-associated dermatitis or other perineal skin disorders or lesions,
- Complete denervation of the pelvic floor
- Conductive inter-uterine devise (IUD/Coil) or metal implants in the abdominal or pelvic area, including the hip and lumbar spine,
- Chronic coughing
- Previous use of Interstim device or Botox for UI
- Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
- Cancer, epilepsy or cognitive dysfunction
- Underlying neurologic/neuromuscular disorder
- Impaired decision making, suicidal thoughts, or drug/alcohol dependence
- Lacks capacity to consent for themselves.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women
The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence. The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence.
Read the detailed description
The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence in women. The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence. This is a randomized prospective controlled study of two active groups with a stimulation frequency difference between the groups.
- Conditions
- Urge Incontinence
- Being tested
- ELITONE UUI
- Keywords
- incontinence, bladder, urge, urgency, stimulation
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELITONE UUIDevice
Also called ELITONE muscle stimulator
External electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active Group A | Experimental | Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A. Receives: Device: ELITONE UUI |
| Active Group B | Active comparator | Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B. Receives: Device: ELITONE UUI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Number of Urinary Incontinence Episodes Per Day
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.
Measured: 6 weeks
Safety Assessed by Number of Serious Adverse Events
Any serious adverse events recorded during the trial.
Measured: 6 weeks
Secondary outcomes (3)
Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL)
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.
Measured: 6 weeks
Efficacy Assessed by Reduction in Average Pads Used Per Day
Efficacy Assessed by Reduction in Average Pads used per day over the 6 week period.
Measured: 6 weeks
Efficacy Assessed by Reduction in Average Bathroom Visits
The efficacy assessed by average bathroom visits during the day and night.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start19 Nov 2020
- Primary completion30 May 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urge IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized between two active groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elidah, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gloria Kolb, M.S., Study director, Elidah, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752709
- Sponsor's protocol ID
- TR-1155
- Status last verified
- Nov 2024
- First submitted
- 22 Jan 2021
- Last updated
- 30 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women
- ClinicalTrials.gov ID
- NCT04752709
- Acronym / sponsor ID
- TR-1155
- Conditions
- Urge Incontinence
- Keywords
- incontinence, bladder, urge, urgency, stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Elidah, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Posted 30 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence. The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence.
Detailed description
The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence in women. The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence. This is a randomized prospective controlled study of two active groups with a stimulation frequency difference between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized between two active groups
| Arm | Type | Receives |
|---|---|---|
| Active Group A | Experimental | Device: ELITONE UUIElectrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A. |
| Active Group B | Active comparator | Device: ELITONE UUIElectrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Predominant urge urinary incontinence as determined by responses to a series of three standard questions from the King's Health Questionnaire; specifically:
- Mild-moderate incontinence symptoms as determined by self-reported typical number of accidents of 1 or more per 24 hours. Symptom severity is later verified with data from the Daily Log (See 5.4)
Key exclusion criteria (20 listed)
- Less than 1 incontinence accident (leak) per day*
- Severe incontinence as determined by self-reported >5 accidents per day
- Currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks
- Vaginal or pelvic surgery within previous 6 months
- Severe Obesity as defined by BMI >= 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELITONE UUIAlso: ELITONE muscle stimulatorExternal electrical stimulation | Device | Active Group A, Active Group B |
Primary outcome
Change in Average Number of Urinary Incontinence Episodes Per Day
Time frame: 6 weeks
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.
Safety Assessed by Number of Serious Adverse Events
Time frame: 6 weeks
Any serious adverse events recorded during the trial.
3 secondary outcomes
Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 6 weeks
Efficacy Assessed by Reduction in Average Pads Used Per Day
Time frame: 6 weeks
Efficacy Assessed by Reduction in Average Bathroom Visits
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria Kolb, M.S. study director
Elidah, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELITONE UUI in people with Urge Incontinence, run by Elidah, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Average Number of Urinary Incontinence Episodes Per Day (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.