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

Hospital Authority, Hong Kong48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostatic Hyperplasia Urinary Retention Acute Disease

Interventions

Alfuzosin GITS (Xatral XL)DRUG

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

North District Hospital

Hong Kong, China

Outcomes

Primary Outcomes

Successful rate of Trial Without Catheter (TWOC) at phase 1

Time frame: 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

Time frame: From the end of phase one to eight months after successful TWOC (the end of phase 2)

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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