---
title: Alfuzosin Versus Placebo in Acute Urinary Retention
nct_id: NCT00453908
overall_status: TERMINATED
phase: PHASE3
sponsor: Sanofi
study_type: INTERVENTIONAL
primary_condition: Urinary Retention
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00453908.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00453908"
ct_last_update_post_date: 2007-08-20
last_seen_at: "2026-05-12T06:00:46.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Alfuzosin Versus Placebo in Acute Urinary Retention

**Official Title:** Does Alfuzosin OD vs. Placebo in Male Patients Facilitate Spontaneous Voiding During Clean Intermittent Self-Catheterization Following Acute Urinary Retention?

**NCT ID:** [NCT00453908](https://clinicaltrials.gov/study/NCT00453908)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** The study was early terminated due to slow and difficult recruitment
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 160
- **Lead Sponsor:** Sanofi
- **Conditions:** Urinary Retention
- **Start Date:** 2004-05
- **CT.gov Last Update:** 2007-08-20

## Brief Summary

The primary objective of the study is to investigate if 14 days of treatment with Alfuzosin compared to placebo, will increase the number of patients with satisfying spontaneous voiding after acute urinary retention treated with Clean Self-Catheterization.

Furthermore is investigated the safety of the medical treatment and self-catheterization.

## Eligibility

- **Minimum age:** 50 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Men with acute urinary retention and catheterized
* Benign hypertrophia of prostate
* Patient is diagnosed in Emergency room or at a acute hospitalization

Exclusion Criteria:

* Known prostate cancer
* Prior urinary retention within 30 days
* Urinary retention occurring in relation to surgery
* Blood in urine
* Difficult or impossible catheterization
* Fever \> 38 degree Celsius
* Decreased kidney function
* Permanent catheter \> 14 days
* Treatment with alfa 1 blocker within 30 days
* Meeting contraindications to treatment with Alfuzosin
* Treatment with other drugs for urinary problems

The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial.
```

## Interventions

- **Alfuzosin** (DRUG)

## Primary Outcomes

- **Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.**

## Secondary Outcomes

- **Number of days until termination of self catheterization**
- **Number of patients with urinary infection requiring treatment**
- **Pressure of voiding, volume of voiding, residual urine after voiding, measured by urine culture and bladder scan at day 14.**

## Locations (1)

- Sanofi-Aventis, Hoersholm, Denmark

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sanofi-aventis|hoersholm||denmark` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00453908.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00453908*  
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