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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

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ClinicalTrials.gov Identifier: NCT00563485
Recruitment Status : Terminated
First Posted : November 26, 2007
Last Update Posted : June 16, 2011
Sponsor:
Information provided by:
Hospital Authority, Hong Kong

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.

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Urinary Retention Drug: Doxazosin GITS (Cardura XL) Drug: Terazosin (Hytrin) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2005
Actual Study Completion Date : November 2006





Primary Outcome Measures :
  1. Successful rate of Trial Without Catheter (TWOC) at phase 1 [ Time Frame: At discharge after TWOC (at the end phase one) ]
  2. 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 :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00563485     History of Changes
Other Study ID Numbers: CRE-2005.313-T
HARECCTR0500049
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: June 2011

Keywords provided by Hospital Authority, Hong Kong:
Benign Prostatic Hyperplasia (BPH)
Acute Retention of Urine (AUR)

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Urinary Retention
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urination Disorders
Urologic Diseases
Doxazosin
Prazosin
Terazosin
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents