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

Not Applicable

Completed

• Conditions: BPH With Urinary Obstruction
• Interventions: Procedure: Early catheter removal; Procedure: Late catheter removal

• Registration Number: NCT03280420
• Lead Sponsor: Salem Hassan Salem Mohamed

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-03-12
• Study First Submitted: 2017-08-12
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-09
• Study First Posted: 2017-09-12
• Primary Completion: 2017-09-16
• Study Completion: 2017-09-16
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early catheter removal	Early catheter removal	30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 3 days.
late catheter removal	Late catheter removal	30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 7 days.

Primary Outcome Measures

Name	Time	Method
The duration for trial without catheter	6 Months	To determine the optimum period to remove catheter in patients complaining of acute urinary retention with benign prostatic hyperplasia.

Secondary Outcome Measures

Name	Time	Method
Factor affecting trial without catheter	6 Months	To evaluate the role of the following in trial without catheter patient's age prostate size residual urine volume prostatic specific antigen (PSA)

Trial Locations

Locations (1)

Faculty of medicine ,Al Azhar university; 🇪🇬 Cairo, El Mokhayam El Daem St.، Ezbet El-Arab, Nasr City, Cairo, Egypt