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TerminatedNCT00563654Updated Jun 16, 2011

Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up

An interventional study of Alfuzosin GITS (Xatral XL) in Prostatic Hyperplasia, Urinary Retention and Acute Disease, sponsored by Hospital Authority, Hong Kong. Terminated at 1 site in China. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2011-06-16.

Sponsored by Hospital Authority, Hong Kong · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
50 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostatic Hyperplasia
  • Urinary Retention
  • Acute Disease

Keywords

  • Benign Prostatic Hyperplasia (BPH)
  • Acute Retention of Urine (AUR)
03

In context

Prostatic Hyperplasia

803 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's planned enrollment of 48 is below the median of 96 across 610 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Hospital Authority, Hong Kong is the lead sponsor of 79 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 50 or above
  • Admitted for AUR due to BPH with PVR of 500 ml or more

Exclusion criteria

Exclusion Criteria:

  • Previous history of TURP
  • Use of alpha blockers within recent 8 months
  • Renal impairment (serum creatinine >140 umol/l)
  • Poor premorbid state
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (estimated)

Interventions

  • DrugAlfuzosin GITS (Xatral XL)
06

What researchers measure

Primary outcomes

  1. Successful rate of Trial Without Catheter (TWOC) at phase 1

    Time frame: At discharge after TWOC (at the end phase one)

  2. 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

  1. 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

  2. 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

07

Study locations

1 site
  • North District Hospital
    Hong Kong, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00563654
Lead sponsor
Hospital Authority, Hong Kong
First posted
Nov 26, 2007
Start date
Oct 2005
Completion
Nov 2006
Last update
Jun 16, 2011

Study contacts

Chi Wai Cheng, Dr
principal investigator · Department of Surgery, Division of Urology, North District Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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