NCT07276919

Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,844 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: Male
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed as a multicenter, randomized, controlled, open-label trial. Participants will be randomized 1:1 into two groups using a block randomization method. 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). The control group will not receive Tamsulosin during this perioperative period. All patients will undergo standard pre-biopsy preparations, including bowel preparation and prophylactic antibiotics. The primary endpoint, Acute Urinary Retention (AUR) incidence, along with secondary endpoints (IPSS, QoL, urinary flow rate, post-void residual urine), will be assessed on the 7th day after the biopsy. Safety indicators, such as the incidence of adverse events like orthostatic hypotension and falls, will also be monitored.

Conditions

• Acute Urinary Retention
• LUTS(Lower Urinary Tract Symptoms)

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-12-11
• Last updated: 2025-12-23

Locations

1 site across 1 country: China