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

• Sponsor: Hospital Authority, Hong Kong (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00563654
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia; Urinary Retention; Acute Disease	Drug: Alfuzosin GITS (Xatral XL)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2005
• Actual Study Completion Date: Nov 1, 2006

Outcome Measures

Primary Outcome Measures

1. Successful rate of Trial Without Catheter (TWOC) at phase 1 [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 [From the end of phase one to eight months after successful TWOC (the end of phase 2)]

Secondary Outcome Measures

1. 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]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North District Hospital	Hong Kong		China

Sponsors and Collaborators

• Hospital Authority, Hong Kong

Investigators

• Principal Investigator: Chi Wai Cheng, Dr, Department of Surgery, Division of Urology, North District Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00563654
• Other Study ID Numbers: CRE-2005.332; HARECCTR0500048
• First Posted: Nov 26, 2007
• Last Update Posted: Jun 16, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: Benign Prostatic Hyperplasia (BPH); Acute Retention of Urine (AUR)
• Additional relevant MeSH terms: Prostatic Hyperplasia; Urinary Retention; Hyperplasia; Acute Disease; Alfuzosin

Study Results

No Results Posted as of Jun 16, 2011