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

NCT ID: NCT01108757

Last Updated: 2017-10-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Catheter-Associated Urinary Tract Infection

Keywords

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catheter urinary tract infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Drug

Group Type EXPERIMENTAL

Bactrim

Intervention Type DRUG

Bactrim DS BID for 3 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Corn starch capsules

Interventions

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Bactrim

Bactrim DS BID for 3 days

Intervention Type DRUG

Placebo

Corn starch capsules

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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American Urogynecologic Society

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew D Barber, MD MHS

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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10-125

Identifier Type: -

Identifier Source: org_study_id