Tamsulosin to prevent the failures of early bladder catheter removal after acute urinary retention in elderly women hospitalized for an acute medical problem
- Conditions
- urinary disorderMedDRA version: 18.1Level: LLTClassification code 10001055Term: Acute retention of urineSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2012-003620-20-FR
- Lead Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Woman hospitalized in internal medicine or geriatrics and acute with acute urine retention (defined as urinary volume collected immediately after the laying of the upper urinary catheter 400 mL) for less than 48 hours ( emergency or in the process of hospitalization)
- Patient beneficiary of a social security scheme or entitled (except AME )
- Patient or their legal representative or trusted person who signed the consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 448
- Chronic retention of urine,
- Retention of anatomical causes pelvic tumor, previous pelvic surgery,
- Retention of neurological causes (spinal, peripheral): peripheral neuropathy, spinal cord compression, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease,
-Other reason for urinary catheterization (eschar protection, monitoring of urine output)
- patient in the end-of-life phase
- Hypersensitivity to tamsulosin hydrochloride, to one of the constituents of the drug or other alpha-blocker,
History of symptomatic orthostatic hypotension,
- Severe hepatic failure,
- Severe renal failure ( creatinine clearance below 10 ml / min according to the Cockcroft )
- Patient unable to express informed consent ( including dementia with MMS < 20) and without legal representation ,
- Planned hospitalization duration less than 6 days.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective is to evaluate the efficacy of a 6-day treatment with tamsulosin versus placebo in women aged over 75 years hospitalized for acute medical problem and with acute urinary retention;Secondary Objective: 1 to show a reduction in the percentage of nosocomial urinary infections under tamsulosin ;<br>2- to evaluate the safety of tamsulosin ;<br>3- compare the length of hospitalization between the two groups .;Primary end point(s): The primary endpoint is the failure rate of urinary catheter withdrawal achieved between J2 (midnight) and J3 (morning) of treatment, requiring a urinary catheter re-installation in the following 72 hours. The failure rates of early bladder catheter withdrawal is estimated at J6.<br> ;Timepoint(s) of evaluation of this end point: The failure rates of early bladder catheter withdrawal is estimated at J6 of treatment
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: J0, J3, J6,J12;Secondary end point(s): 1. Percentage of symptomatic and asymptomatic nosocomial urinary infections on a urine collection in case of symptoms and systematic at J6.<br> 2. Percentage of orthostatic hypotension searched systematically before starting treatment, at D3 and D6, and at any time in case of postural symptoms (dizziness, blurred vision, faintness or syncope).<br> 3. Number of days of hospitalization in both groups