Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to BPH Under Tamsulosin Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to Benign Prostatic Hyperplasia Under Tamsulosin Treatment

Conditions
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BPH With Urinary Obstruction

Intervention / Treatment
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* Procedure: Early catheter removal
* Procedure: Late catheter removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients having first attack of acute urinary retention secondary to BPH. Exclusion Criteria: Renal impairment. Suspected urethral stricture. Neurogenic bladder. Cancer prostate. Medically induced retention. Previous use of alpha blockers. History of drug hypersensitivity or allergy to Tamsulosin.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: early catheter removal<br>30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 3 days. | Procedure: Early catheter removal<br>* 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.<br>* Other names: After 3 days catheter removal;|
| Active Comparator: late catheter removal<br>30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 7 days. | Procedure: Late catheter removal<br>* 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.<br>* Other names: After 7 days catheter removal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute urinary retention, BPH, TWOC, Tamsulosin