Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy

NCT ID: NCT07276919

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1844 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2028-01-01

Brief 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)

Keywords

acute urinary retention; LUTS(Lower urinary tract symptoms); tamsulosin; prostate biopsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Tamsulosin 0.2mg

Intervention Type: DRUG

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).

Control Group

Participants will not receive Tamsulosin during the perioperative period but will undergo the standard prostate biopsy procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Tamsulosin Hydrochloride Sustained-Release Capsules

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital Miyun Hospital

UNKNOWN

Sponsor Role: collaborator

Taiyuan Central Hospital of Shanxi Medical University

OTHER

Sponsor Role: collaborator

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University First Hospital, Urology Department

Beijing, Outside U.S./Canada, China

Countries

China

Central Contacts

Kai Zhang, Doctor Degree

Role: CONTACT

Phone: +8618909870823

Email: yaokaifeng@pku.edu.cn

Facility Contacts

Kai Dr. Zhang, Doctor degree

Role: primary

Other Identifiers

20251018

Identifier Type: -

Identifier Source: org_study_id