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

NeuroTherapia, Inc.

Status: Terminated

Conditions: Catheter-Associated Urinary Tract Infection

Treatments: Drug: Bactrim; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01108757

10-125

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

Drug

Experimental group

Treatment:

Drug: Bactrim

Placebo

Placebo Comparator group

Treatment:

Other: Placebo