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Trial History Detail on 2015-07-06

CUHK_CCT00152

2008-04-10

Retrospective

Nil

Nil

Division of Urology, Department of Surgery, the Chinese University of Hong Kong

NA

Ng Chi Fai

Department of Surgery, 4/F, Clinical Science Building, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT

Phone: 26322625, Fax: 26377974,

e-mail: ngcf@surgery.cuhk.edu.hk

Professor, Department of Surgery

Ng Chi Fai

Department of Surgery, 4/F, Clinical Science Building, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT

Phone: 26322625, Fax: 26377974,

e-mail: ngcf@surgery.cuhk.edu.hk

Professor, Department of Surgery

Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo With Long Term Follow Up after successful Trial Without Catheter In Acute Urinary Retention

Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo With Long Term Follow Up after successful Trial Without Catheter In Acute Urinary Retention

Long term efficacy of Alfuzosin 10 mg daily in patient after successful trial without catheter

Hong Kong

Yes

2006-09-20

Benign prostatic hyperplasia (BPH), Acute urine Retention (AUR)

Drug

Alfuzosin GITS 10 mg

2 years

Placebo

Inclusion Criteria •Aged 50 or above •Presented with first episode of AUR due to BPH with residual urine of 500 - 1500ml. •Successful TWOC after use of Alfuzosin GITS

Exclusion criteria •Previous history of TURP or other form of invasive therapy for benign prostate hyperplasia •Patient suspected or confirmed to have carcinoma of prostate •Use of alpha blockers within recent 6 months •Use of phytotherapy or 5-alpha reductase inhibitors within recent 6 months •Clot retention secondary to haematuria of any cause •Patients with depressive illness on medication, extra-pyramidal disorders, neurological disease •Patients with unstable angina, myocardial infarction, transient ischaemic attacks, cerebrovascular accident or congestive cardiac failure during the previous 6 months •Patients contraindicated for alfuzosin A.Known hypersensitivity to alfuzosin B.Orthostatic hypotension C.Hepatic insufficiency •Poor premorbid state

>=50

nil

Male

Interventional

Randomized

Placebo

Single-blind

Parallel

2006-10-07

72

Complete

The primary objective of the study is to compare alfuzosin GITS 10 mg daily with placebo, in delaying or avoiding invasive therapy for BPH on long term follow up of Hong Kong Chinese males patients achieving a successful TWOC after AUR secondary to BPH.

The secondary objective is to investigate the safety of alfuzosin GITS and also predicting factors for recurrent AUR.

No

2015-07-06

ChiCTR-TRC-08000719

2010-05-04


Yes

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