Clinical trial NCT00336921: Alfuzosin for Treating Acute Urinary Retention
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Urinary Retention
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-06-15
Enrollment: 156
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients with successful voiding after catheter removal
timeFrame: Day 3 and 4
measure: Adverse events
timeFrame: From the beginning to the end of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi
name: Bruno Jolain
role: STUDY_DIRECTOR
References: