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

This study has been terminated.

First Received: November 21, 2007 Last Updated: June 23, 2009 History of Changes

Sponsor:	Hospital Authority, Hong Kong
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00563485

Purpose

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.

Condition	Intervention
Prostatic Hyperplasia Urinary Retention	Drug: Doxazosin GITS (Cardura XL) Drug: Terazosin (Hytrin)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Terazosin Terazosin hydrochloride dihydrate Doxazosin Doxazosin mesylate

U.S. FDA Resources

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:

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) ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	120
Study Start Date:	October 2005
Study Completion Date:	November 2006

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563485

Locations

China
Prince of Wales Hospital
Hong Kong, China

Sponsors and Collaborators

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

More Information

Additional Information:

HAREC Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CRE-2005.313-T, HARECCTR0500049
Study First Received:	November 21, 2007
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00563485 History of Changes
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

Benign Prostatic Hyperplasia (BPH)
Acute Retention of Urine (AUR)

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Adrenergic Agents
Urination Disorders
Physiological Effects of Drugs
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Urinary Retention

Genital Diseases, Male
Pharmacologic Actions
Terazosine
Doxazosin
Hyperplasia
Pathologic Processes
Prostatic Hyperplasia
Urologic Diseases
Therapeutic Uses
Adrenergic Antagonists

ClinicalTrials.gov processed this record on February 08, 2010