Tamsulosin for Urinary Retention in Hospitalized Older Women (TAMSU)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Tamsulosin to Facilitate Early Catheter Removal After Urinary Retention in Older Women Hospitalized for an Acute Medical Condition|
- early catheter removal failure [ Time Frame: between days 3 and 6 ] [ Designated as safety issue: No ]need to replace a catheter within 72h following day 3 catheter removal
- hospital-acquired urinary tract infection [ Time Frame: between days 1 and 12 ] [ Designated as safety issue: No ]any symptomatic urinary tract infection proved by urine culture
- orthostatic hypotension [ Time Frame: days 1 to 6 ] [ Designated as safety issue: Yes ]blood pressure drop > 20/10 mmHg between lying and standing
- length of hospitalization [ Time Frame: from day 1 ] [ Designated as safety issue: No ]number of days in the ward where the patient was enrolled
|Study Start Date:||January 2013|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Tamsulosin (0.4 mg/j) (1 tablet / day for 6 days)
Drug: Tamsulosin (0.4 mg/j)
(1 tablet / day for 6 days)
Placebo Comparator: placebo
1 tablet / day for 6 days
(1 tablet / day for 6 days)
Background: Urinary tract infections are the most frequent hospital-acquired infections. A majority is catheter-associated and the main risk factor is the duration of catheterization. Early removal is therefore a priority. Treatment with alpha-blockers in men with acute urinary retention due to prostatic disease increases the rate of successful early catheter removal. No intervention has been studied in elderly women in whom urinary retention is usually favored by an acute health issue. However, alpha-blockers have proved effective in other circumstances, as the prevention of acute urinary retention after hysterectomy and the treatment of chronic voiding disorders.
Objective: To evaluate the benefit of tamsulosin for 6 days in older women hospitalized for an acute medical condition and experiencing urinary retention.
Primary endpoint: Rate of failed early catheter removal (day 3), requiring placement of another catheter within the following 72 hours.
Secondary endpoints: rate of hospital-acquired urinary tract infections, rate of hypotension, length of hospitalization.
Design: Double-blind and multicentric randomized controlled trial (tamsulosin 0.4 mg/day or placebo orally for 6 days).
Number of patients: We assume a 40% failure rate of early catheter removal in the placebo group. Expecting a 10% dropout rate, 448 patients need to be randomized to show a reduction of this rate by one third in the tamsulosin group with two-sided alpha level at 5% and beta level at 20%.
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.
Non-inclusion 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); patients at the end of life; contra-indication to alpha-blockers.
Course of the study: The patient receives a treatment dose in the evening inclusion (day 0) and the five following evenings. The catheter is removed after the third dose, between midnight and noon. The patient is followed up until day 12.
Total time: 36 months (35 months of inclusion + 12 days of participation per patient).
Number of participating centers: 8 Expected number of inclusions per month and center: 2-4
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747993
|Service de médecine interne, Hôpital Tenon|
|Paris, France, 75020|
|Principal Investigator:||Eric Bouvard, MD||Assistance Publique|