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
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...
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”
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: Hospital Authority, Hong Kong Other
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 February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00563485
