Tamsulosin for Urinary Retention in Hospitalized Older Women

NCT01747993 | Terminated Phase 3

• 2 other identifiers: P 101005AOR11001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Retention

Keywords

Urinary retention; urinary catheterization; alpha blocking agents; women; elder

Outcome Measures

Primary Outcomes (1)

• early catheter removal failure

  need to replace a catheter within 72h following day 3 catheter removal

  between days 3 and 6

Secondary Outcomes (3)

• hospital-acquired urinary tract infection

  between days 1 and 12

• orthostatic hypotension

  days 1 to 6

• length of hospitalization

  from day 1

Study Arms (2)

tamsulosin

EXPERIMENTAL

Tamsulosin (0.4 mg/j) (1 tablet / day for 6 days)

Drug: Tamsulosin (0.4 mg/j)

placebo

PLACEBO COMPARATOR

1 tablet / day for 6 days

Drug: Placebo

Interventions

Tamsulosin (0.4 mg/j) DRUG

(1 tablet / day for 6 days)

tamsulosin

Placebo DRUG

(1 tablet / day for 6 days)

placebo

Eligibility Criteria

• Age: 75 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de médecine interne, Hôpital Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

Urinary Retention

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Eric Bouvard, MD

  Assistance Publique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 2, 2014

Record last verified: 2014-10

Locations

FR (1)