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| Name | Class |
|---|---|
| Taiyuan Central Hospital of Shanxi Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Control Group | No Intervention | Participants will not receive Tamsulosin during the perioperative period but will undergo the standard prostate biopsy procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AUR | Incidence of Acute Urinary Retention (AUR) | From biopsy to the 7th day after biopsy. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kai Zhang, Doctor Degree | Contact | +8618909870823 | yaokaifeng@pku.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital, Urology Department | Beijing | Outside U.S./Canada | 100034 | China |
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| 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. |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |