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Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00563654
First Posted: November 26, 2007
Last Update Posted: June 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Authority, Hong Kong
  Purpose
The purpose of the study is to compare alfuzosin GITS once daily versus placebo 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 Acute Disease Drug: Alfuzosin GITS (Xatral XL)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo on the Successful Rate of Trial Without Catheter in Patients With 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: 48
Study Start Date: October 2005
Study Completion Date: November 2006
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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): NCT00563654


Locations
China
North District 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
  More Information

ClinicalTrials.gov Identifier: NCT00563654     History of Changes
Other Study ID Numbers: CRE-2005.332
HARECCTR0500048
First Submitted: November 21, 2007
First Posted: November 26, 2007
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
Acute Disease
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urination Disorders
Urologic Diseases
Disease Attributes
Alfuzosin
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