Acute Disease, Prostatic Hyperplasia, Urinary Retention
Conditions
Keywords
Benign Prostatic Hyperplasia (BPH), Acute Retention of Urine (AUR)
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.
Interventions
DRUGAlfuzosin GITS (Xatral XL)
Sponsors
Hospital Authority, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed