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...
Date First Received: November 21, 2007
Last Updated: June 16, 2008
Verified by: Hospital Authority, Hong Kong, June 2008
Clinical Trial Phase: N/A | Start Date: October 2005
Overall Status: Terminated
Estimated Enrollment: 120
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Doxazosin GITS (Cardura XL)
- Drug: Terazosin (Hytrin)
Outcome Measures for this Clinical Trial
Primary Measures
- Successful rate of Trial Without Catheter (TWOC) at phase 1
- Time Frame: At discharge after TWOC (at the end phase one)
- 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)
- Time Frame: From the end of phase one to eight months after successful TWOC (the end of phase 2)
Secondary 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
- 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
- Time Frame: At the end of phase I (discharge after TWOC) and at the end of phase 2
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Hospital Authority, Hong Kong
Overall Clinical Trial Officials and Contacts
Chi Wai Cheng, Dr Principal Investigator Department of Surgery, Division of Urology, North District Hospital/ The Chinese University of Hong Kong
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00563485
Study ID Number: CRE-2005.313-T
ClinicalTrials.gov Identifier: NCT00563485
Health Authority: Hong Kong: Ethics Committee
Clinical Trials Authorship and Review
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