Urinary Retention Clinical Trial
— TAMSUOfficial title:
Tamsulosin to Facilitate Early Catheter Removal After Urinary Retention in Older Women Hospitalized for an Acute Medical Condition
Catheter-associated urinary infections are the most common hospital-acquired infections and can be prevented by early catheter removal. This study evaluates tamsulosin to reduce the failure of early catheter removal has been studied in elderly women hospitalized for an acute condition and experiencing acute urinary retention: 448 women 75-year old or more without an anatomical or neurological cause of urinary retention will be randomized to a 6 days course of tamsulosin 0.4 mg or placebo. Catheter removal will be attempted after the third dose of tamsulosin and the need to replace another catheter within 72 hours will define a failed attempt.
Status | Terminated |
Enrollment | 34 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 75 Years and older |
Eligibility |
Inclusion Criteria: - 75-year or older women hospitalized in an internal medicine or geriatric ward and with a bladder catheter for less than 48 hours for acute urinary retention. Exclusion Criteria: - chronic urinary retention; - acute retention with an anatomical (pelvic tumor, pelvic surgery) or neurological cause (peripheral neuropathy, spinal cord compression, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease); - catheter placed for another indication (pressure ulcer protection, urine output monitoring); - patient at the end of life; - contra-indication to alpha-blockers. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Service de médecine interne, Hôpital Tenon | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | early catheter removal failure | need to replace a catheter within 72h following day 3 catheter removal | between days 3 and 6 | No |
Secondary | hospital-acquired urinary tract infection | any symptomatic urinary tract infection proved by urine culture | between days 1 and 12 | No |
Secondary | orthostatic hypotension | blood pressure drop > 20/10 mmHg between lying and standing | days 1 to 6 | Yes |
Secondary | length of hospitalization | number of days in the ward where the patient was enrolled | from day 1 | No |
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