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.
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
First received: November 21, 2007
Last updated: June 15, 2011
Last verified: June 2011
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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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

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

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

Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
Principal Investigator: Chi Wai Cheng, Dr Department of Surgery, Division of Urology, North District Hospital/ The Chinese University of Hong Kong
  More Information

ClinicalTrials.gov Identifier: NCT00563485     History of Changes
Other Study ID Numbers: CRE-2005.313-T  HARECCTR0500049 
Study First Received: November 21, 2007
Last Updated: June 15, 2011
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:
Prostatic Hyperplasia
Urinary Retention
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Urination Disorders
Urologic Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Antihypertensive Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Urological Agents

ClinicalTrials.gov processed this record on May 26, 2016