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

September 20, 2017 updated by: Salem Hassan Salem Mohamed

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: early catheter removal
30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 3 days.
Procedure: 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.

Other Names:
  • After 3 days catheter removal
Active Comparator: late catheter removal
30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 7 days.
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.

Other Names:
  • After 7 days catheter removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The duration for trial without catheter
Time Frame: 6 Months
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
Time Frame: 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)
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salem Hassan Salem Mohamed

Investigators

  • Study Chair: Mohamed M Badr, PHD, Al-Azhar University
  • Study Director: Mohamed F El Saeed El Ebiary, MD, Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2017

Primary Completion (Actual)

September 16, 2017

Study Completion (Actual)

September 16, 2017

Study Registration Dates

First Submitted

August 12, 2017

First Submitted That Met QC Criteria

September 9, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 20, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123urology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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