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OpenTrials
Completed

NCT Number: NCT00336921

Alfuzosin for Treating Acute Urinary Retention

The primary objective of the study is to assess the efficacy of alfuzosin 10mg daily in the return to successful voiding after removal of the catheter following a first episode of acute urinary retention (AUR) in patients suffering from benign prostatic hyperplasia (BPH).

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Key information

Conditions

Acute Urinary Retention

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-aventis

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First episode of painful AUR related to BPH requiring catheterization
  • Residual volume between 500ml and 1500ml obtained at the time of catheterization and during the first one hour after catheterization

Exclusion criteria

  • Participated in another investigational study within 3 months before recruitment
  • Suspect bladder neuro-dysfunction unrelated to etiology;
  • Single Bladder neck disease;
  • Acute/chronic prostatitis;
  • Diagnosed prostate carcinoma;
  • Suspected prostate carcinoma diagnosed by ultrasound wave;
  • Surgical history of prostate and urethra;
  • Diagnosed/suspected abnormality in urethra structure;
  • Bladder stone;
  • Blood urine retention caused by any reason;
  • Residual volume less than 500 ml
  • Residual volume more than 1500 ml
  • AUR not due to BPH
  • Parkinson's disease
  • Insulin dependent diabetes
  • Known/suspected multiple sclerosis;
  • Stroke/MI within 6 months prior to enrolment;
  • AST, ALT and Creatinine > 1.5x upper limit; neutrophil < 3,000/mm³; platelet < 100,000/mm³;
  • Unstable/severe heart failure;
  • History of postural hypertension/hypotension;
  • Known hypersensitivity to α-receptor blocker;
  • Suspected/diagnosed expansible nerval disease;
  • Treatment with sympathomimetic agent within 1 week prior to enrolment, except OTC drug for cold intermittently;
  • Treatment with α1-receptor blocker within 1 month prior to enrolment;
  • Treatment with tricyclic antidepressants, anticholinergic agents, sympathomimetic agent (other than the above reason), first generation antihistaminic, except the treatment with stable β sympathomimetic agent/ anticholinergic agents lasting more than 1 week for Asthma and COPD (Chronic Obstructive Pulmonary Disease);
  • Treatment with Disopyramide

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Alfuzosin

Drug

Once daily

Placebo

Drug

Once daily

Primary outcomes

  1. Percentage of patients with successful voiding after catheter removal

    Time frame: Day 3 and 4

  2. Adverse events

    Time frame: From the beginning to the end of the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Double-blind, Randomized,Placebo Controlled Study of Alfuzosin 10mg od in the Return to Successful Voiding in Patients With a First Episode of Acute Urinary Retention Due to Benign Prostatic Hyperplasia

Important dates

Study start
2006
Primary completion
2007
First posted
Jun 15, 2006
Registry last updated
Sep 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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