Tamsulosin for Urinary Retention in Hospitalized Older Women

Urinary Retention Clinical Trial

— TAMSU  

Official title:

Tamsulosin to Facilitate Early Catheter Removal After Urinary Retention in Older Women Hospitalized for an Acute Medical Condition

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01747993
• Other study ID #: P 101005
• Secondary ID: AOR11001
• Status: Terminated
• Phase: Phase 3
• First received: December 10, 2012
• Last updated: October 1, 2014
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 75 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Drug:
• Tamsulosin (0.4 mg/j)
(1 tablet / day for 6 days)
• Placebo
(1 tablet / day for 6 days)

Locations

Country	Name	City	State
France	Service de médecine interne, Hôpital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early catheter removal failure	need to replace a catheter within 72h following day 3 catheter removal	between days 3 and 6	No
Secondary	hospital-acquired urinary tract infection	any symptomatic urinary tract infection proved by urine culture	between days 1 and 12	No
Secondary	orthostatic hypotension	blood pressure drop > 20/10 mmHg between lying and standing	days 1 to 6	Yes
Secondary	length of hospitalization	number of days in the ward where the patient was enrolled	from day 1	No