Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy

Peking University

Status and phase: Not yet enrolling; Phase 4

Conditions: Acute Urinary Retention; LUTS(Lower Urinary Tract Symptoms)

Treatments: Drug: Tamsulosin 0.2mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07276919

20251018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,844 estimated patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,844 participants in 2 patient groups

Tamsulosin Group

Experimental group

Description:

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).

Treatment:

Drug: Tamsulosin 0.2mg

Control Group

No Intervention group

Description:

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