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Pump problems: new study investigates why some men struggle with their penile prosthesis

NCT ID NCT06376513

Knowledge-focused Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is for men who have had a penile prosthesis implanted for erectile dysfunction. It aims to understand how well they can manipulate the pump, including hand strength and sensation. Researchers will also look at how these abilities relate to erection rigidity and sexual satisfaction for both the patient and their partner. The goal is to find out why some patients have difficulty using their device.

What this could mean

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

What this could lead to
If successful, this study could help doctors identify patients who may struggle with their penile prosthesis pump and guide improvements in device design or training.
What could go wrong
This is a small, early observational study with only 60 participants. It does not test a new treatment, so it may not lead to immediate changes in care.

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 60 people

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

Started

Jun 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

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.

Ages

18 years and older

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: * The patients will be included based on the following criteria: * Adults * Erectile Dysfunction, and had undergone penile prosthesis implantation for more than 3 months * Able to comprehend the nature and purpose of the research * Having provided informed consent The partner will be included based on the following criteria : * Adults * Having a partner who meets the inclusion criteria * Able to comprehend the nature and purpose of the research * Having provided informed consent Exclusion Criteria: * Patients with a dysfunctional penile prosthesis (reservoir, pump, or cylinders anomaly) * Adults subject to legal protective measures. * Individuals not affiliated with a social security scheme or beneficiaries of a similar scheme.

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Conditions

The condition(s) this trial relates to.

erectile dysfunction Orgasm

As listed by the trial registrant

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

Penile prosthesis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Urology, Lyon Sud Hospital,

    RECRUITING

    Pierre-Bénite, 69310, France