Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy

NCT07276919 | Not Yet Recruiting Phase 4

• 1 other identifier: 20251018
• Study Type: interventional
• Target: 1,844
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Urinary Retention; LUTS(Lower Urinary Tract Symptoms)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of AUR

  Incidence of Acute Urinary Retention (AUR)

  From biopsy to the 7th day after biopsy.

Secondary Outcomes (4)

• IPSS

  From baseline (pre-biopsy) to the 7th day after biopsy.

• QoL

  From baseline (pre-biopsy) to the 7th day after biopsy.

• Qmax

  From baseline (pre-biopsy) to the 7th day after biopsy.

• PVR

  From baseline (pre-biopsy) to the 7th day after biopsy.

Study Arms (2)

Tamsulosin Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Tamsulosin 0.2mg 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).

Also known as: Tamsulosin Hydrochloride Sustained-Release Capsules

Tamsulosin Group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University First Hospital Miyun Hospital: collaborator
• Taiyuan Central Hospital of Shanxi Medical University: collaborator

Study Sites (1)

Peking University First Hospital, Urology Department

Beijing, Outside U.S./Canada, 100034, China

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Central Study Contacts

Kai Zhang, Doctor Degree

CONTACT

+8618909870823; yaokaifeng@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)