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NOT YET RECRUITING
NCT07276919
PHASE4

Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

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.

Official title: Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy: A Multicenter, Randomized, Controlled, Open-Label Study

Key Details

Gender

MALE

Age Range

40 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

1844

Start Date

2026-02-01

Completion Date

2028-01-01

Last Updated

2025-12-23

Healthy Volunteers

No

Interventions

DRUG

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).

Locations (1)

Peking University First Hospital, Urology Department

Beijing, Outside U.S./Canada, China