Tamsulosin for Urinary Retention in Hospitalized Older Women
Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Retention
Intervention: Tamsulosin (0.4 mg/j) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s): Eric Bouvard, MD, Principal Investigator, Affiliation: Assistance Publique
Summary
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.
Clinical Details
Official title: Tamsulosin to Facilitate Early Catheter Removal After Urinary Retention in Older Women Hospitalized for an Acute Medical Condition
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: early catheter removal failure
Secondary outcome: hospital-acquired urinary tract infectionorthostatic hypotension length of hospitalization
Detailed description:
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
Eligibility
Minimum age: 75 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Service de médecine interne, Hôpital Tenon, Paris 75020, France
Additional Information
Starting date: January 2013
Last updated: October 1, 2014
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