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The aim of this work is to compare between early (3days) and late(7days) removal of urinary catheter after acute urine retention in patients with Benign Prostatic Hyperplasia under Tamsulosin treatment.
This is a prospective randomized study, Men with acute urinary retention secondary to benign prostatic hyperplasia were catheterized and then, if they fulfilled the entry criteria, were randomly assigned to receive 0.4 mg tamsulosin hydrochloride for three days or seven days, After that the catheter was removed and the ability to void unaided assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early catheter removal | Active Comparator | 30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 3 days. |
|
| late catheter removal | Active Comparator | 30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early catheter removal | Procedure | Patients will receive selective alpha blocker ( tamsulosin 0.4mg ) once daily and the catheter will be removed after 3 days. After catheter removal, patients will be allowed to void and will be discharged home who will have a successful void more than 200 cc of urine. Patients who will fail to void will be re-catheterized and will be prepared for prostatectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| The duration for trial without catheter | To determine the optimum period to remove catheter in patients complaining of acute urinary retention with benign prostatic hyperplasia. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Factor affecting trial without catheter | To evaluate the role of the following in trial without catheter patient's age prostate size residual urine volume prostatic specific antigen (PSA) | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed M Badr, PHD | Al-Azhar University | Study Chair |
| Mohamed F El Saeed El Ebiary, MD | Al-Azhar University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine ,Al Azhar university | Cairo | El Mokhayam El Daem St.، Ezbet El-Arab, Nasr City, Cairo | Egypt |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 26, 2017 | |
| Reset | Oct 24, 2017 | |
| Release | Oct 29, 2017 | |
| Reset | Aug 3, 2018 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2017 | Sep 16, 2017 | Prot_SAP_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 26, 2017 | Oct 24, 2017 | |||
| Oct 29, 2017 |
All patients were catheterized and received urinary antiseptic and then randomly divided into two groups : Group I :30 patients received Tamsulosin 0.4 mg once daily and catheter removed after 3 days. Group II :30 patients received Tamsulosin 0.4 mg once daily and catheter removed after 7 days.
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|
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| Late catheter removal | Procedure | Patients will receive selective alpha blocker ( tamsulosin 0.4mg ) once daily and the catheter will be removed after 7 days. After catheter removal, patients will be allowed to void and will be discharged home who will have a successful void more than 200 cc of urine. Patients who will fail to void will be re-catheterized and will be prepared for prostatectomy. |
|
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| Aug 3, 2018 |