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Can a fluid injection make prostate surgery safer and less bloody?

NCT ID NCT07749794

Disease control Sponsor: Benha University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial tests whether injecting a fluid mixture around the prostate before surgery can make the procedure easier and reduce bleeding. Men with enlarged prostates and moderate-to-severe urinary symptoms will be randomly assigned to either the new hydrodissection-assisted technique or the conventional surgery. The study will compare blood loss, operation time, and recovery outcomes to see if the new approach offers benefits.

What this could mean

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

Active substance
Hydrodissection-assisted bipolar prostatic enucleation-enucleoresection with subcapsular injection of diluted norepinephrine and methylene blue
What this could lead to
If successful, this technique could make prostate surgery safer and faster, with less bleeding and quicker recovery for men with enlarged prostates.
What could go wrong
This is a single-center trial with 100 participants, so results may not apply broadly. The injection adds complexity and could carry risks like infection or tissue damage.

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 100 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

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: * Benign prostatic hyperplasia. * Prostate volume greater than 60 cc as measured by transrectal ultrasonography. * Moderate-to-severe lower urinary tract symptoms, defined as an International Prostate - Symptom Score of 12 or higher. * Failure of or poor response to medical management. Exclusion Criteria: * History of prostate cancer or suspicious findings on prostate biopsy. * Active urinary tract infection. * Severe cardiovascular, pulmonary, or other systemic comorbidities that contraindicate surgery. * Previous prostate surgery, including transurethral resection of the prostate or open prostatectomy. * Chronic urinary retention associated with neurogenic bladder. Hypersensitivity to norepinephrine or methylene blue.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Lower Urinary Tract Symptoms

As listed by the trial registrant

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

Lower urinary tract symptoms Prostatic hyperplasia

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

  • Benha University Hospital

    Banhā, Qalyubia Governorate, 13511, Egypt

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