Alfuzosin for Treating Acute Urinary Retention

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Sanofi

Status and phase

Completed
Phase 2

Conditions

Acute Urinary Retention

Treatments

Drug: Alfuzosin
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00336921
L_9645

Details and patient eligibility

About

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).

Enrollment

156 patients

Sex

Male

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

156 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
Alfuzosin 10mg
Treatment:
Drug: Alfuzosin
2
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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