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New bladder irrigation device aims to cut Post-Surgery infections

NCT ID NCT07510685

Disease control Sponsor: University of Pisa 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a closed-system bladder irrigation device designed to reduce urinary tract infections after endoscopic urologic surgery. 240 patients undergoing prostate or bladder tumor surgery were randomly assigned to use the new device or standard irrigation. The device allows healthcare workers to flush the bladder without opening the catheter system, potentially lowering contamination. The main goal was to see if it reduced bacteria in the urine.

What this could mean

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

Active substance
Closed-system bladder irrigation flow switch device
What this could lead to
If it works, this device could lower infection rates after bladder surgery, reducing the need for antibiotics and speeding recovery.
What could go wrong
This is a single-center trial with 240 patients, so results may not apply to all hospitals. The device may not significantly reduce infections compared to standard 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

240 people

The number who actually took part.

Started

Feb 2025

Finished

Dec 2025

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

Anyone

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: * Patients aged 18 years or older * Patients undergoing endoscopic urologic surgery (transurethral resection of the prostate or transurethral resection of bladder tumor) * Patients requiring postoperative continuous bladder irrigation * Ability to provide written informed consent Exclusion Criteria: * Pre-existing urinary tract infection or bacteriuria prior to surgery * Known contraindication to urinary catheterization or bladder irrigation * Patients undergoing emergency surgery * Inability to provide informed consent

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Conditions

The condition(s) this trial relates to.

bacterial urinary tract infection benign prostatic hyperplasia Catheter-Related Infections urinary bladder carcinoma Urinary Bladder Neoplasms urinary tract infection prevention target

As listed by the trial registrant

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

Benign prostatic hyperplasia Bladder cancer Urinary tract infection bacterial

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56100, Italy

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