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New prostate surgery aims to cut incontinence by saving the urethra

NCT ID NCT07678489

Disease control Sponsor: Sami-Ramzi Leyh-Bannurah 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests a new robot-assisted surgery for localized prostate cancer that leaves the full length of the urethra intact. The goal is to help men regain urinary continence faster after prostate removal. About 60 men with early-stage prostate cancer will undergo the procedure to see if it is safe and feasible.

What this could mean

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

Active substance
Total en bloc urethra preservation at robot-assisted prostatectomy (ToP-RAP)
What this could lead to
If successful, this technique could help men recover bladder control faster after prostate cancer surgery, improving quality of life.
What could go wrong
This is a small, early feasibility study. The technique may not work for all patients, and there is a risk of cancer not being fully removed.

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

Jan 2024

Expected to finish

Dec 2030

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: * Life expectancy \>=10 years (biological age) * No prior prostate therapy (laser enucleation, TURP, focal therapy) * No pelvic/prostate radiotherapy; * No prior abdominal/rectal surgery; * No prior (neoadjuvant) androgen-deprivation therapy * No prior stroke/cerebral ischemia with neurological sequelae; * No neurological disease (e.g., Parkinson's) * Transrectal or transperineal bilateral biopsy \>=12 cores (MRI-ultrasound fusion, targeted + systematic) * PSA \<=15 ng/mL; prostate volume \<=80 mL * Biopsy ISUP grade 1-3 (= Gleason 3+3 / 3+4 / 4+3) * No Gleason pattern 5; no intraductal, cribriform or neuroendocrine carcinoma * mp/bpMRI (mandatory if biopsy Gleason \>=3+4) * No suspected metastases at staging Exclusion Criteria: \- Failure to meet any inclusion criterion, or patient declining ToP-RAP (offered standard RARP per EAU guidelines)

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma Urinary Incontinence

As listed by the trial registrant

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

Prostate cancer (localized), urinary incontinence (C61)

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Clinic Bel Etage

    RECRUITING

    Düsseldorf, 40217, Germany

    Contact Email: •••••@•••••

  • Diakonie Klinikum Jung-Stilling

    RECRUITING

    Siegen, 57074, Germany

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