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Simple pill may prevent painful urinary blockage after prostate biopsy

NCT ID NCT07276919

Symptom relief Sponsor: Peking University First Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether taking tamsulosin, a drug often used for enlarged prostate, can prevent difficulty urinating after a prostate biopsy. About 1,844 men will either take the drug for a few days around the biopsy or receive no preventive medication. The goal is to see if the drug lowers the chance of needing a catheter and improves overall urinary symptoms.

What this could mean

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

Active substance
Tamsulosin Hydrochloride (0.2 mg sustained-release capsules)
What this could lead to
If it works, this could provide a simple, short-term medication to prevent painful urinary retention and improve urination after a prostate biopsy.
What could go wrong
This is a Phase 4 trial, but it has not yet started recruiting. The benefit may be small, and some men may still experience urinary problems despite treatment.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,844 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jan 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 to 85 years

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: * Male, aged 40 to 85 years (inclusive). * Meets indications for prostate biopsy per clinical guidelines (e.g., suspicious nodule on digital rectal exam, suspicious lesion on imaging, tPSA \>10 ng/mL, or tPSA 4-10 ng/mL with f/t \<0.16 or PSAD \>0.15). * Voluntarily participates and provides written informed consent. Exclusion Criteria: * Previous prostate surgery, urinary diversion, or intermittent catheterization. * Use of alpha-adrenergic blockers (e.g., Tamsulosin, Doxazosin) within one week prior to screening. * Known or suspected allergy/intolerance to Tamsulosin, or history of orthostatic hypotension. * Indwelling urinary catheter or suprapubic cystostomy tube at the time of biopsy. * History of severe bleeding disorders. * Poorly controlled or unstable comorbidities such as hypertension or diabetes. * Severe immunosuppression. * Severe psychological disorders or uncooperative for the biopsy procedure. * Active urinary tract infection or neurogenic bladder. * Any other condition deemed by the investigator as unsuitable for participation.

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Conditions

The condition(s) this trial relates to.

Lower Urinary Tract Symptoms

As listed by the trial registrant

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

Acute urinary retention Luts(lower urinary tract symptoms)

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

  • Peking University First Hospital, Urology Department

    Beijing, Outside U.S./Canada, 100034, China

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