NCT00563485TerminatedNot Applicable
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
Hospital Authority, Hong Kong1 site in 1 country120 target enrollmentStarted: October 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Successful rate of Trial Without Catheter (TWOC) at phase 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- Proportion of subjects with hypotension or symptoms related to hypotension after administration of treatment drug for TWOC(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)(At the end of phase I (discharge after TWOC) and at the end of phase 2)
Investigators
Study Sites (1)
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