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

NCT ID: NCT03280420

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-12

Study Completion Date

2017-09-16

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.

Conditions

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BPH With Urinary Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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early catheter removal

30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 3 days.

Group Type ACTIVE_COMPARATOR

Early catheter removal

Intervention Type 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.

late catheter removal

30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 7 days.

Group Type ACTIVE_COMPARATOR

Late catheter removal

Intervention Type 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.

Interventions

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Early catheter removal

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.

Intervention Type PROCEDURE

Late catheter removal

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.

Intervention Type PROCEDURE

Other Intervention Names

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After 3 days catheter removal After 7 days catheter removal

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.
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Salem Hassan Salem Mohamed

OTHER

Sponsor Role lead

Responsible Party

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Salem Hassan Salem Mohamed

Cairo, Egypt

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed M Badr, PHD

Role: STUDY_CHAIR

Al-Azhar University

Mohamed F El Saeed El Ebiary, MD

Role: STUDY_DIRECTOR

Al-Azhar University

Locations

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Faculty of medicine ,Al Azhar university

Cairo, El Mokhayam El Daem St.، Ezbet El-Arab, Nasr City, Cairo, Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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123urology

Identifier Type: -

Identifier Source: org_study_id