Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up
Not Applicable
Terminated
- Conditions
- Prostatic HyperplasiaUrinary RetentionAcute Disease
- Registration Number
- NCT00563654
- Lead Sponsor
- Hospital Authority, Hong Kong
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 48
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Successful rate of Trial Without Catheter (TWOC) at phase 1 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 From the end of phase one to eight months after successful TWOC (the end of phase 2)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
North District Hospital
🇨🇳Hong Kong, China