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| ID | Type | Description | Link |
|---|---|---|---|
| HARECCTR0500048 |
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The purpose of the study is to compare alfuzosin GITS once daily versus placebo in achieving a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in delaying or avoiding a TURP.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfuzosin GITS (Xatral XL) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Successful rate of Trial Without Catheter (TWOC) at phase 1 | At discharge after TWOC (at the end phase one) | |
| Late failure of TWOC of, which is defined as recurrent of AUR or the need of invasive therapy among those who are successful in TWOC in phase 1 | From the end of phase one to eight months after successful TWOC (the end of phase 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with hypotension or symptoms related to hypotension after administration of treatment drug for TWOC | From the time of treatment drug administration to the end of phase 1 | |
| Peak flow rate (Qmax), voided volume (Vcomp) and post-voided residue volume (PVR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chi Wai Cheng, Dr | Department of Surgery, Division of Urology, North District Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North District Hospital | Hong Kong | China |
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| At the end of phase I (discharge after TWOC) and at the end of phase 2 |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D016055 | Urinary Retention |
| D000208 | Acute Disease |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C047638 | alfuzosin |
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