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Tamsulosin for Urinary Retention in Hospitalized Older Women (TAMSU)

This study has been terminated.
(low inclusion)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01747993
First received: December 10, 2012
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Urinary Retention
Drug: Tamsulosin (0.4 mg/j)
Drug: Placebo
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 34
Study Start Date: January 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747993

Locations
France
Service de médecine interne, Hôpital Tenon
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Eric Bouvard, MD Assistance Publique
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01747993     History of Changes
Other Study ID Numbers: P 101005, AOR11001
Study First Received: December 10, 2012
Last Updated: October 1, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Urinary retention; urinary catheterization; alpha blocking agents; women; elder

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases
Tamsulosin
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 20, 2014