Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy

NCT07276919 · tracked via the Priya Life Science China tracker

Sponsor

Peking University First Hospital

Phase

Phase 4

Started

2026-02-01

Last updated

2025-12-23

Condition(s) studied

Acute Urinary RetentionLUTS(Lower Urinary Tract Symptoms)

Investigational drug(s) / intervention(s)

Tamsulosin 0.2mg

Tamsulosin 0.2mg: The experimental group will receive Tamsulosin Hydrochloride Sustained-Release Capsules (0.2 mg, once daily at night) starting 3 days before the biopsy and continuing until the 6th day after the procedure (10 doses total).

Study summary

The goal of this clinical trial is to learn if the drug Tamsulosin Hydrochloride works to treat urination difficulties after a prostate biopsy in men.The main questions it aims to answer are:

* Does Tamsulosin Hydrochloride lower the rate of Acute Urinary Retention (inability to urinate) after a prostate biopsy?
* Does Tamsulosin Hydrochloride improve participants' urination symptoms, quality of life, urine flow rate, and post-void residual urine volume?

Researchers will compare the drug group to a control group (receiving no preventive medication) to see if Tamsulosin Hydrochloride works to prevent urination problems.

Participants will:

* Be randomly assigned to either take Tamsulosin Hydrochloride or receive no preventive medication.
* If in the drug group, take one capsule of Tamsulosin Hydrochloride every night, starting 3 days before the biopsy and continuing until 6 days after the biopsy (10 doses total).
* Undergo a standard prostate biopsy procedure (either through the rectum or perineum).
* Return to the clinic 7 days after the biopsy for a follow-up checkup, which will include questions about their symptoms (IPSS and QoL scores) and tests to measure urine flow and bladder emptying.

Eligibility

Sex

MALE

Min age

40 Years

Max age

85 Years

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of AUR — From biopsy to the 7th day after biopsy.
Incidence of Acute Urinary Retention (AUR)

Trial sites (1)

Facility	City	Region	Status
Peking University First Hospital, Urology Department	Beijing	Outside U.S./Canada

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07276919 on ClinicalTrials.gov ↗ ← All trials in China