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

Primary Purpose

Catheter-Associated Urinary Tract Infection

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bactrim
Placebo
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter-Associated Urinary Tract Infection focused on measuring catheter, urinary tract infection

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Urinary Tract Infection
Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as >100,000 colony forming units/mL

Secondary Outcome Measures

Full Information

First Posted
April 21, 2010
Last Updated
October 17, 2017
Sponsor
The Cleveland Clinic
Collaborators
American Urogynecologic Society
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1. Study Identification

Unique Protocol Identification Number
NCT01108757
Brief Title
Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients
Acronym
PRECAUTION
Official Title
Prevention of Catheter-Associated Urinary Tract Infections in Patients Undergoing Incontinence and Reconstructive Pelvic Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Unfeasible because of low accrual
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
American Urogynecologic Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-Associated Urinary Tract Infection
Keywords
catheter, urinary tract infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bactrim
Intervention Description
Bactrim DS BID for 3 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Corn starch capsules
Primary Outcome Measure Information:
Title
Number of Participants With Urinary Tract Infection
Description
Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as >100,000 colony forming units/mL
Time Frame
7 days following catheter removal

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew D Barber, MD MHS
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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