Tamsulosin for Urinary Retention in Hospitalized Older Women
Tamsulosin for Urinary Retention in Hospitalized Older Women
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.
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
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.