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Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients (PRECAUTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01108757
Recruitment Status : Terminated (Unfeasible because of low accrual)
First Posted : April 22, 2010
Results First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Collaborator:
American Urogynecologic Society
Information provided by (Responsible Party):
The Cleveland Clinic

Study Description
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Brief Summary:
The study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic or placebo at the time of catheter removal. The investigators hypothesize that prophylactic antibiotics will reduce the rate of infection.

Condition or disease Intervention/treatment Phase
Catheter-Associated Urinary Tract Infection Drug: Bactrim Other: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Catheter-Associated Urinary Tract Infections in Patients Undergoing Incontinence and Reconstructive Pelvic Surgery: A Randomized Controlled Trial
Study Start Date : April 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Drug Drug: Bactrim
Bactrim DS BID for 3 days
Placebo Comparator: Placebo Other: Placebo
Corn starch capsules


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Urinary Tract Infection [ Time Frame: 7 days following catheter removal ]
    Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as >100,000 colony forming units/mL


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Requires catheterization >24h hours following incontinence or pelvic reconstructive surgery

Exclusion Criteria:

  • Receipt of antibiotics for either prophylaxis or treatment of a known infection during the postoperative hospitalization
  • Allergy to sulfonamides or trimethoprim
  • Non-English speaking
  • Pregnancy
  • Breast feeding
  • Severe renal impairment (creatinine clearance <30)
  • Patients taking dofetilide, methenamine, procaine, warfarin, procainamide, methotrexate.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108757


Locations
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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
American Urogynecologic Society
Investigators
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Principal Investigator: Matthew D Barber, MD MHS The Cleveland Clinic
More Information
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01108757    
Other Study ID Numbers: 10-125
First Posted: April 22, 2010    Key Record Dates
Results First Posted: October 18, 2017
Last Update Posted: October 18, 2017
Last Verified: October 2017
Keywords provided by The Cleveland Clinic:
catheter
urinary tract infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Urinary Tract Infections
Disease Attributes
Pathologic Processes
Urologic Diseases
Trimethoprim, Sulfamethoxazole Drug Combination
 Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents