Urinary IncontinenceNCT06620419
Clinical Study of External Electrical Stimulation for Male Incontinence
A study testing Perineal-applied electrical stimulation in people with Urinary 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 Elidah neuromuscular stimulation treatment to reduce incontinence in men post-prostatectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Perineal-applied electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for robotic-assisted laparoscopic prostatectomy
- Read and speak English
- Predominant SUI of at least 1 pad/day
Who cannot join
- History or symptoms of urinary incontinence, urinary retention, extra-urethral incontinence, overflow incontinence
- Complete denervation of the pelvic floor
- Severe Obesity as defined by BMI \>= 40
- Has undergone pre-op pelvic floor exercise strengthening
- Pelvic pain/painful bladder syndrome
- Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
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- History of epilepsy
- Underlying neurologic/neuromuscular disorder
- Metal implants in the abdomen or pelvic area
- Chronic coughing
- Impaired decision making, suicidal thoughts, or drug/alcohol dependence
- Uncontrolled intercurrent illness that would limit compliance with study requirements
- Lacks capacity to adhere with study requirements
- Lacks capacity to consent for themselves.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Perineal Electrical Stimulation for Urinary Incontinence in Men
The purpose of this research is to evaluate the effectiveness of the Elidah neuromuscular stimulation treatment to reduce incontinence in men post-prostatectomy.
- Conditions
- Urinary Incontinence
- Being tested
- Perineal-applied electrical stimulation
- Keywords
- male, men, prostatetectomy, incontinence, electrical stimulation
- Medical subject headings
- Urinary Incontinence, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal-applied electrical stimulationDevice
Also called Elidah, Elitone, Edytone
Small controller that outputs stimulation for stress incontinence and OAB, attached to a male-anatomy thin GelPad placed in the perineal area.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Self-applied electrical stimulation for 6 weeks. Receives: Device: Perineal-applied electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Leakage by Pad weight
24-hr pad weight
Measured: 6 weeks
Secondary outcomes (6)
Safety measured by no Adverse events
No adverse events
Measured: 6 weeks
Quality of Life Improvement
Incontinence I-QoL survey
Measured: 6 weeks
Quality of Life Improvement
Sexual Health SHIM survey
Measured: 6 weeks
Reduction in leakage
As measured by Pads per day
Measured: 6 weeks
Reduction in leakage at Night
As measured by Nocturia episode
Measured: 6 weeks
Reduction in leakage
As measured by daytime leaking episodes
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 posted1 Oct 2024
- Study start15 May 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary 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
- Not applicable
- Intervention model
- Single group
- Model description
- Perineal-applied electrical stimulation shaped for males.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elidah, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gloria Kolb, MS,MBA, Principal investigator, Elidah, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620419
- Sponsor's protocol ID
- TR-1168
- Status last verified
- Oct 2025
- First submitted
- 16 May 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Perineal Electrical Stimulation for Urinary Incontinence in Men
- ClinicalTrials.gov ID
- NCT06620419
- Acronym / sponsor ID
- TR-1168
- Conditions
- Urinary Incontinence
- Keywords
- male, men, prostatetectomy, incontinence, electrical stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Elidah, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
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 Elidah neuromuscular stimulation treatment to reduce incontinence in men post-prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Perineal-applied electrical stimulation shaped for males.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Perineal-applied electrical stimulationSelf-applied electrical stimulation for 6 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for robotic-assisted laparoscopic prostatectomy
- Read and speak English
- Predominant SUI of at least 1 pad/day
Key exclusion criteria (14 listed)
- History or symptoms of urinary incontinence, urinary retention, extra-urethral incontinence, overflow incontinence
- Complete denervation of the pelvic floor
- Severe Obesity as defined by BMI \>= 40
- Has undergone pre-op pelvic floor exercise strengthening
- Pelvic pain/painful bladder syndrome
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 |
|---|---|---|
| Perineal-applied electrical stimulationAlso: Elidah, Elitone, EdytoneSmall controller that outputs stimulation for stress incontinence and OAB, attached to a male-anatomy thin GelPad placed in the perineal area. | Device | Treatment group |
Primary outcome
Reduction in Leakage by Pad weight
Time frame: 6 weeks
24-hr pad weight
6 secondary outcomes
Safety measured by no Adverse events
Time frame: 6 weeks
Quality of Life Improvement
Time frame: 6 weeks
Quality of Life Improvement
Time frame: 6 weeks
Reduction in leakage
Time frame: 6 weeks
Reduction in leakage at Night
Time frame: 6 weeks
Reduction in leakage
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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, MS,MBA principal investigator
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 Perineal-applied electrical stimulation in people with Urinary 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 3 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Reduction in Leakage by Pad weight (time frame: 6 weeks). 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 27 Jan 2026.