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Electric implant aims to restore erections after prostate cancer surgery

NCT ID NCT05650866

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new implantable device that delivers electrical pulses to nerves to help men get erections after prostate removal for cancer. Twenty men aged 30-70 who are already scheduled for nerve-sparing prostatectomy will either get the device or not. Researchers will check safety, pain, and how well the device works over 6 months.

What this could mean

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

Active substance
implantable electrical stimulation device
What this could lead to
If it works, this device could help men regain natural erections after prostate cancer surgery, reducing the need for pills or injections.
What could go wrong
This is a very early, small trial with only 20 participants. The device is implanted during surgery, so there are risks like infection, device failure, or pain. It may not work for everyone.

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 20 people

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

Started

May 2023

Expected to finish

Aug 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

30 to 70 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: * Men of ages between 30-70 years; * Men with indication for nerve-sparing prostatectomy surgery; * Localised prostate cancer considered suitable for bilateral nerve sparing prostatectomy according to clinical criteria * International Index of Erectile Function (IIEF-15) erectile function domain score equal to or greater than 26 prior prostatectomy; * Men interested in minimizing the effect of radical prostatectomy on erectile function; * Ability to read and understand patient information materials and willingness to sign a written informed consent. Exclusion Criteria: * Men with neurological disease, including a history of spinal cord injury or trauma; * IIEF-15 erectile function domain score less than 26 prior prostatectomy; * Failure to demonstrate adequate nocturnal erectile function prior prostatectomy; * History of erectile dysfunction, priapism and Peyronie disease; * History of previous pelvic surgery, trauma or irradiation therapy; * Currently have an active implantable device; * Patient diagnosed with neurologic degenerative diseases that may negatively impact erectile functions; * Identification of technical or clinical limitation to properly apply the use of nerve-sparing techniques during operation; * Inability to understand and demonstrate device use instructions; * Patients with insulin-dependent diabetes who suffer peripheral neuropathy or other diabetes associated complications; * Patient unwillingness to engage in sexual activity; * Patient is currently participating in another clinical investigation that would serve as a contraindication to implant a neurostimulator device to augment erectile function; * Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other drug or device study during the next 24 months; * Possess any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure/study; * Patient is a member of a vulnerable population (Vulnerable participants include those who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, and employee volunteers).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Australian Prostate Centre

    RECRUITING

    North Melbourne, Victoria, 3051, Australia

  • Epworth HealthCare

    ACTIVE_NOT_RECRUITING

    Richmond, Victoria, 3121, Australia

  • Royal Melbourne Hospital

    ACTIVE_NOT_RECRUITING

    Melbourne, Victoria, 3050, Australia

  • St. Vincent's Private Hospital

    ACTIVE_NOT_RECRUITING

    Fitzroy, Victoria, 3065, Australia

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