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

Catheter-Associated Urinary Tract Infection Clinical Trial

— PRECAUTION  

Official title:

Prevention of Catheter-Associated Urinary Tract Infections in Patients Undergoing Incontinence and Reconstructive Pelvic Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01108757
• Other study ID #: 10-125
• Status: Terminated
• Phase: N/A
• First received: April 21, 2010
• Last updated: October 17, 2017
• Start date: April 2010
• Est. completion date: August 2013

Study information

• Verified date: October 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Catheter-Associated Urinary Tract Infection
• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Drug:
• Bactrim
Bactrim DS BID for 3 days

Other:
• Placebo
Corn starch capsules

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	American Urogynecologic Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days following catheter removal