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

This study is currently recruiting participants.
Verified January 2013 by The Cleveland Clinic
Sponsor:
Collaborator:
American Urogynecologic Society
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01108757
First received: April 21, 2010
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Catheter-Associated Urinary Tract Infection
 Drug: Bactrim
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Urinary Tract Infection [ Time Frame: 7 days following catheter removal ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Urinary tract infection [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 176
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug Drug: Bactrim
Bactrim DS BID for 3 days
Placebo Comparator: Placebo Other: Placebo
Corn starch capsules

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108757

Contacts
Contact: Ly Pung, RN 216-445-8090 pungl@ccf.org
Contact: Ellen Solomon, MD 216-445-0796 solomoe@ccf.org

Locations
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ly Pung, RN     215-445-8090     pungl@ccf.org    
Sub-Investigator: Ellen Solomon, MD            
Sponsors and Collaborators
The Cleveland Clinic
American Urogynecologic Society
Investigators
Principal Investigator: Matthew D Barber, MD MHS The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01108757     History of Changes
Other Study ID Numbers: 10-125
Study First Received: April 21, 2010
Last Updated: January 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
catheter
urinary tract infection

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on June 17, 2013