Randomized Trial Comparing Terazosin 5 mg Daily and Doxazosin GITS 4 mg Daily for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up

June 15, 2011 updated by: Hospital Authority, Hong Kong

Randomized Trial Comparing Terazosin 5 mg Daily and Doxazosin GITS 4 mg Daily in the Successful Rate of Trial Without Catheter in Acute Urinary Retention With Long Term Follow up

The purpose of the study is to compare two alpha blockers, terazosin and doxazosin GITS, in achieving a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in delaying or avoiding a TURP.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

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

  • China
      • Hong Kong, China
        • Prince of Wales Hospital

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Aged 50 or above
  • Admitted for AUR due to BPH with PVR of 500 ml or more

Exclusion Criteria:

  • Previous history of TURP
  • Use of alpha blockers within recent 8 months
  • Renal impairment (serum creatinine >140 umol/l)
  • Poor premorbid state

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: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful rate of Trial Without Catheter (TWOC) at phase 1
Time Frame: At discharge after TWOC (at the end phase one)
At discharge after TWOC (at the end phase one)
Late failure of TWOC of, which is defined as recurrent of AUR or the need of invasive therapy among those who are successful in TWOC in phase 1
Time Frame: From the end of phase one to eight months after successful TWOC (the end of phase 2)
From the end of phase one to eight months after successful TWOC (the end of phase 2)

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with hypotension or symptoms related to hypotension after administration of treatment drug for TWOC
Time Frame: From the time of treatment drug administration to the end of phase 1
From the time of treatment drug administration to the end of phase 1
Peak flow rate (Qmax), voided volume (Vcomp) and post-voided residue volume (PVR)
Time Frame: At the end of phase I (discharge after TWOC) and at the end of phase 2
At the end of phase I (discharge after TWOC) and at the end of phase 2

Collaborators and Investigators

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

Sponsor

Hospital Authority, Hong Kong

Investigators

  • Principal Investigator: Chi Wai Cheng, Dr, Department of Surgery, Division of Urology, North District Hospital/ The Chinese University of Hong Kong

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

October 1, 2005

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 21, 2007

First Posted (Estimate)

November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 15, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2005.313-T
  • HARECCTR0500049

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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