A Phase 4 interventional study of Tamsulosin 0.2mg in Acute Urinary Retention and LUTS(Lower Urinary Tract Symptoms), sponsored by Peking University First Hospital. Not yet recruiting at 1 site in China. Open to male participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Peking University First Hospital · Phase 4, Interventional, and Prevention
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:
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:
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.
406 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's planned enrollment of 1,844 is above the median of 93 across 260 interventional studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
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
Participants will not receive Tamsulosin during the perioperative period but will undergo the standard prostate biopsy procedure.
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
Incidence of AUR
Incidence of Acute Urinary Retention (AUR)
Time frame: From biopsy to the 7th day after biopsy.
IPSS
Change in International Prostate Symptom Score (IPSS)
Time frame: From baseline (pre-biopsy) to the 7th day after biopsy.
QoL
Change in Quality of Life (QoL) score related to urinary symptoms
Time frame: From baseline (pre-biopsy) to the 7th day after biopsy.
Qmax
Maximum urinary flow rate (Qmax)
Time frame: From baseline (pre-biopsy) to the 7th day after biopsy.
PVR
Post-void residual (PVR) urine volume
Time frame: From baseline (pre-biopsy) to the 7th day after biopsy.
Plan to share: No
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This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Peking University First Hospital