Tamsulosin for Urinary Retention in Hospitalized Older Women (TAMSU)

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.

Study Overview

• Status: Terminated
• Conditions: Urinary Retention
• Intervention / Treatment: Drug: Tamsulosin (0.4 mg/j); Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • Service de médecine interne, Hôpital Tenon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tamsulosin; 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	Drug: Placebo; (1 tablet / day for 6 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
early catheter removal failure	need to replace a catheter within 72h following day 3 catheter removal	between days 3 and 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital-acquired urinary tract infection	any symptomatic urinary tract infection proved by urine culture	between days 1 and 12
orthostatic hypotension	blood pressure drop > 20/10 mmHg between lying and standing	days 1 to 6
length of hospitalization	number of days in the ward where the patient was enrolled	from day 1

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Eric Bouvard, MD, Assistance Publique

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Estimate): October 2, 2014
• Last Update Submitted That Met QC Criteria: October 1, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Urinary retention; urinary catheterization; alpha blocking agents; women; elder
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: P 101005; AOR11001 (Other Identifier: Assistance Publique)