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Shock therapy for leaks? device aims to curb Post-Prostate surgery incontinence

NCT ID NCT06620419

Symptom relief Sponsor: Elidah, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a small device that delivers mild electrical stimulation to the perineum (the area between the scrotum and anus) to help men who leak urine after prostate removal surgery. Thirty men who are scheduled for robotic prostate surgery and already use at least one pad a day will use the device. Researchers will measure changes in pad weight, number of pads used, and quality of life to see if the treatment reduces leakage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Elidah neuromuscular stimulation device (perineal electrical stimulation)
What this could lead to
If it works, this could offer a non-drug, non-surgical option to reduce urine leakage after prostate surgery.
What could go wrong
This is a small early study with only 30 men, so results may not apply to everyone. The device may not work for all types of incontinence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Scheduled for robotic-assisted laparoscopic prostatectomy * Read and speak English * Predominant SUI of at least 1 pad/day Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

multiple endocrine neoplasia type 1 Urinary Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urinary incontinence

Contacts and locations

Locations

  • Elidah

    Monroe, Connecticut, 06468, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.