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Self-Catheterization may cut infections before prostate surgery

NCT ID NCT07555964

Disease control Sponsor: University Hospital, Bordeaux 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two ways to drain urine in men with blocked bladders before prostate surgery: self-catheterization (done by the patient several times a day) versus a permanent tube. The goal is to see if self-catheterization leads to fewer infections. About 106 men over 50 will take part, and they will be followed for three months after surgery.

What this could mean

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

Active substance
clean intermittent self-catheterization (ICSC) versus indwelling catheter (IDC)
What this could lead to
If self-catheterization works better, it could reduce infections and improve quality of life for men waiting for BPH surgery.
What could go wrong
This is a small, early-stage trial with only 106 participants, so results may not apply to everyone. Self-catheterization requires training and may not suit 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.

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 106 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

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

50 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: * Men over 50 years old; * Confirmed diagnosis of benign prostatic hyperplasia (BPH); * Prostate volume greater than 40 grams; * Presence of acute urinary retention with failure to wean from the catheter despite medical treatment with alpha-blocker for at least 48 hours * Indication for surgical management of BPH; * Patient affiliated with or a beneficiary of a social security scheme; * Signed informed consent for participation in the study. Exclusion Criteria: * Patient with a history of prostate surgery (including BPH surgery), prostatic artery embolization or Urolift implant placement are not considered a history of prostate surgery; * Patient with symptomatic urethral stricture; * Patient with a bladder emptying disorder of neurogenic origin; * Patient with an anatomical contraindication to ICSC (urethral stricture, false urethral route); * Patient who had urine drainage by suprapubic catheter * Patient with motor, neurological, anatomical, or cognitive difficulties preventing the education or learning of ICSC; * Patient contraindicated for surgical management of their BPH; * Patient unable to understand the research documents and provide informed consent; * Persons subject to legal protection measures or placed under judicial protection.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Urinary Retention urinary tract infection

As listed by the trial registrant

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

Intermittent urethral catheterization Prostatic hyperplasia Surgical procedures Urinary catheterization Urinary retention Urinary tract infections

How to take part

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

  1. The places running it

    5 sites. 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

  • APHP la Pitié-Salpêtrière

    Paris, France

  • CHU d'Angers

    Angers, France

  • CHU de Toulouse Rangueil

    Toulouse, France

  • Centre d'Urologie Bordeaux Saint Gatien

    Bourdeaux, France

  • Hôpital Prive Francheville

    Périgueux, France

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