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 - Tabular View

Tracking Information

First Received Date ^ICMJE

November 21, 2007

Last Updated Date

June 23, 2009

Start Date ^ICMJE

October 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Successful rate of Trial Without Catheter (TWOC) at phase 1 [ Time Frame: 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) ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00563485 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]
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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prostatic Hyperplasia
Urinary Retention

Intervention ^ICMJE

Drug: Doxazosin GITS (Cardura XL)
Drug: Terazosin (Hytrin)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

120

Completion Date

November 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00563485

Responsible Party

Study ID Numbers ^ICMJE

CRE-2005.313-T, HARECCTR0500049

Study Sponsor ^ICMJE

Hospital Authority, Hong Kong

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Chi Wai Cheng, Dr

Department of Surgery, Division of Urology, North District Hospital/ The Chinese University of Hong Kong

Information Provided By

Hospital Authority, Hong Kong

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP