NCT00563654

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

First QC Date

November 21, 2007

Last Update Submit

June 15, 2011

Conditions

Prostatic HyperplasiaUrinary RetentionAcute Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Interventions

Alfuzosin GITS (Xatral XL)DRUG

Eligibility Criteria

Age50 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North District Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Prostatic HyperplasiaUrinary RetentionAcute Disease

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chi Wai Cheng, Dr

    Department of Surgery, Division of Urology, North District Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

October 1, 2005

Study Completion

November 1, 2006

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations

CN(1)