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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: LUTS(Lower Urinary Tract Symptoms); Acute Urinary Retention
• Intervention / Treatment: Drug: Tamsulosin 0.2mg

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.

• Study Type: Interventional
• Enrollment (Estimated): 1844
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kai Zhang, Doctor Degree; Phone Number: +8618909870823; Email: yaokaifeng@pku.edu.cn

Study Locations

• China
  • Outside U.S./Canada
    • Beijing, Outside U.S./Canada, China, 100034
      • Peking University First Hospital, Urology Department
      • Contact: Kai Dr. Zhang, Doctor degree; Phone Number: 0086-10-83575602; Email: kaizhangpku@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tamsulosin Group; 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).	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).; Other Names: Tamsulosin Hydrochloride Sustained-Release Capsules
No Intervention: Control Group; Participants will not receive Tamsulosin during the perioperative period but will undergo the standard prostate biopsy procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AUR	Incidence of Acute Urinary Retention (AUR)	From biopsy to the 7th day after biopsy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPSS	Change in International Prostate Symptom Score (IPSS)	From baseline (pre-biopsy) to the 7th day after biopsy.
QoL	Change in Quality of Life (QoL) score related to urinary symptoms	From baseline (pre-biopsy) to the 7th day after biopsy.
Qmax	Maximum urinary flow rate (Qmax)	From baseline (pre-biopsy) to the 7th day after biopsy.
PVR	Post-void residual (PVR) urine volume	From baseline (pre-biopsy) to the 7th day after biopsy.

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Taiyuan Central Hospital of Shanxi Medical University; Peking University First Hospital Miyun Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Estimated): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: prostate biopsy; tamsulosin; acute urinary retention; LUTS(Lower urinary tract symptoms)
• Additional Relevant MeSH Terms: Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Lower Urinary Tract Symptoms; Sulfur Compounds; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Benzene Derivatives; Benzenesulfonamides; Sulfonamides; Sulfones; Tamsulosin
• Other Study ID Numbers: 20251018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No