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Could a 3-Week head start on a urinary implant transform recovery?

NCT ID NCT03962569

Symptom relief Sponsor: CAMC Health System 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This pilot study explores whether activating an artificial urinary sphincter three weeks after implantation, rather than the usual four to six weeks, can safely improve urinary incontinence and quality of life. The device is commonly used in men with moderate to severe incontinence following prostate cancer treatment. Researchers will monitor complications and measure changes in incontinence interference and quality-of-life scores over a year. The goal is to see if a shorter waiting period can lead to earlier symptom relief without added risks.

What this could mean

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

Active substance
Artificial urinary sphincter (AUS) device, activated early at 3 weeks post-implantation
What this could lead to
If early activation is safe and effective, it could shorten recovery time and improve quality of life for men with moderate to severe urinary incontinence after prostate cancer treatment.
What could go wrong
This is a small pilot study with only 25 participants, and early activation may increase the risk of complications such as device erosion or infection. Results may not apply to all patients.

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.

Participants

25 people

The number who actually took part.

Started

Aug 2019

Finished

Jan 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

All male patients with moderate to severe urinary incontinence who have been treated for prostate cancer (radical prostatectomy, External Beam Radiation therapy or brachytherapy, or Incontinence related to trans urethral resection of the prostate (TURP) or simple prostatectomy undergoing artificial urinary sphincter placement at Charleston Area Medical Center by Dr. Joshua Lohri, D.O.

Ages

18 to 99 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * All patients undergoing artificial urinary sphincter (AUS) placement by single surgeon, Joshua Lohri, DO. Exclusion Criteria: * Any patient who has previously undergone artificial urinary sphincter placement and presents for revision or additional cuff placement. * Any patient who is undergoing combined artificial urinary sphincter and inflatable penile prosthesis placement. * Any patient who is a poor candidate for early activation due to poor condition at presentation or signs of infection.

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Conditions

The condition(s) this trial relates to.

Urinary Incontinence

As listed by the trial registrant

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

Incontinence, urinary

Contacts and locations

Locations

  • Charleston Area Medical Center

    Charleston, West Virginia, 25301, United States

More trials for these conditions

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