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One surgery or two? trial tests prostate removal during bladder stone operation

NCT ID NCT07831486

NEW Symptom relief Sponsor: Beni-Suef University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Men with bladder stones caused by an enlarged prostate often face a choice: remove only the stones, or also trim the prostate in the same operation. This trial randomly assigns 104 men to one of those two approaches and compares how well each clears the stones and improves urinary symptoms. Researchers also track which men who skip prostate surgery later need it anyway, looking for clues that could guide the decision.

What this could mean

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

Active substance
Transurethral resection of the prostate (TURP) performed during bladder stone surgery
What this could lead to
If removing prostate tissue during stone surgery works better, it could spare some men a second operation and ease urinary symptoms sooner.
What could go wrong
Combining two procedures in one session may add bleeding, infection, or recovery time, and the trial is small and single-center, so results may not apply everywhere.

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 104 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jul 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

40 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: * Adult men aged 40 years or older. * Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). * International Prostate Symptom Score (IPSS) \>= 8. * Prostate size \>= 30 grams (measured by ultrasonography). * Maximum urinary flow rate (Qmax) \<= 15 mL/s. * Presence of urinary bladder calculus/calculi confirmed by diagnostic imaging. * Written informed consent provided prior to study enrollment. Exclusion Criteria: * Evidence or history of urethral stricture. * Known or suspected prostate cancer. * Known or suspected bladder cancer / urothelial malignancy. * Neurogenic bladder dysfunction. * Chronic urinary retention with overflow incontinence. * Previous prostate or bladder neck surgery (e.g., prior TURP, TUIP, open prostatectomy). * Active urinary tract infection (UTI) at the time of surgery (patients treated for infection preoperatively may be reassessed for eligibility).

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia bladder calculus

As listed by the trial registrant

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

Bladder stone

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

  • Faculty of Medicine, Beni-Suef University

    RECRUITING

    Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

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