Trial | NCT01108757  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Study Participants

    52
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.
Study Started
Apr 30
2010
Primary Completion
Aug 31
2013
Study Completion
Aug 31
2013
Results Posted
Oct 18
2017
Last Update
Oct 18
2017

Drug Bactrim

Bactrim DS BID for 3 days

Other Placebo

Corn starch capsules

Drug Experimental

Placebo Placebo Comparator

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.

Summary

Drug

Placebo

All Events

Event Type Organ System Event Term

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

Drug

Placebo

Total

52
Participants

Body mass index

26.5
kg/m^2 (Mean)
Standard Deviation: 3.5

Age, Customized

Region of Enrollment

Sex: Female, Male

Overall Study

Drug

Placebo