Back to resultsRandomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up
Primary Purpose
Prostatic Hyperplasia, Urinary Retention, Acute Disease
Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Alfuzosin GITS (Xatral XL)
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia (BPH), Acute Retention of Urine (AUR)
Eligibility Criteria
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
Sites / Locations
- North District Hospital
Outcomes
Primary Outcome Measures
Successful rate of Trial Without Catheter (TWOC) at phase 1
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
Secondary Outcome Measures
Proportion of subjects with hypotension or symptoms related to hypotension after administration of treatment drug for TWOC
Peak flow rate (Qmax), voided volume (Vcomp) and post-voided residue volume (PVR)
Full Information
NCT ID
NCT00563654
First Posted
November 21, 2007
Last Updated
June 15, 2011
Sponsor
Hospital Authority, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00563654
Brief Title
Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia, Urinary Retention, Acute Disease
Keywords
Benign Prostatic Hyperplasia (BPH), Acute Retention of Urine (AUR)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Alfuzosin GITS (Xatral XL)
Primary Outcome Measure Information:
Title
Successful rate of Trial Without Catheter (TWOC) at phase 1
Time Frame
At discharge after TWOC (at the end phase one)
Title
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 Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Wai Cheng, Dr
Organizational Affiliation
Department of Surgery, Division of Urology, North District Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
North District Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up
We'll reach out to this number within 24 hrs