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Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy

NCT07276919 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1844

Last updated 2025-12-23

No results posted yet for this 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.

Conditions

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

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).

Sponsors & Collaborators

  • Peking University First Hospital Miyun Hospital

    collaborator UNKNOWN

  • Taiyuan Central Hospital of Shanxi Medical University

    collaborator OTHER

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2028-01-01
Completion
2028-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07276919 on ClinicalTrials.gov