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NCT00563654 Clinical Trial

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

Prostatic Hyperplasia Clinical Trial

Official title:
Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo on the Successful Rate of Trial Without Catheter in Patients With Acute Urinary Retention With Long Term Follow up

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00563654
Other study ID # CRE-2005.332
Secondary ID HARECCTR0500048
Status Terminated
Phase N/A
First received November 21, 2007
Last updated June 15, 2011
Start date October 2005
Est. completion date November 2006

Study information
Verified date June 2011
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 48
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 50 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Alfuzosin GITS (Xatral XL)

Locations
Country Name City State
China North District Hospital Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Successful rate of Trial Without Catheter (TWOC) at phase 1 At discharge after TWOC (at the end phase one)
Primary 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 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
Secondary 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
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