Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI) (STOPP UTI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01450800
First received: October 10, 2011
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients.


Condition Intervention Phase
Urinary Tract Infection
Drug: Nitrofurantoin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antibiotic Prophylaxis for Urinary Tract Infection in Patients Requiring Catheterization After Urogynecologic Surgery

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Urinary Tract Infections [ Time Frame: three weeks post-operative ] [ Designated as safety issue: No ]
    The primary outcome was treatment for UTI within the first 3 weeks after surgery. Treatment for UTI was defined to include any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery. Clinically suspected treatment was defined to include treatment given empirically upon development of urinary symptoms or prescribed based on urine test results. Culture-proven UTI was defined as a urine culture with greater than 100,000 colony-forming units of a single organism.


Secondary Outcome Measures:
  • Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ] [ Designated as safety issue: No ]
    We examined risk of UTI as related to vaginal estrogen therapy

  • Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ] [ Designated as safety issue: No ]
    We examined risk of UTI as related to history of recurrent UTIs

  • Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ] [ Designated as safety issue: No ]
    We examined risk of UTI as related to preoperative UTI treatment

  • Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ] [ Designated as safety issue: No ]
    We examined risk of UTI as related to Creatinine Clearance

  • Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ] [ Designated as safety issue: No ]
    We examined risk of UTI as related to sling as part of surgery

  • Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ] [ Designated as safety issue: No ]
    We examined risk of UTI as related to postoperative void trial PVR by performing a logistic regression analysis

  • Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ] [ Designated as safety issue: No ]
    We examined risk of UTI as related to total postoperative catheter days

  • Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ] [ Designated as safety issue: No ]
    We examined risk of UTI as related to postoperative catheter type


Other Outcome Measures:
  • Antibiotic Resistance to Macrobid [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
    We examined for macrobid resistance on urine culture results within 3 weeks of surgery


Enrollment: 163
Study Start Date: August 2011
Study Completion Date: September 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nitrofurantoin
Nitrofurantoin 100mg by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
Drug: Nitrofurantoin
Nitrofurantoin 100mg po daily to be taken every day the patient uses a catheter for up to one week post-operatively
Other Names:
  • Macrobid
  • Macrodantin
Placebo Comparator: Placebo
Placebo drug 1 tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
Drug: Placebo
Participants randomized to placebo will be instructed to take placebo one tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
Other Names:
  • Placebo medication
  • Inactive medication

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing urogynecologic surgery
  • Receive postoperative catheterization

Exclusion Criteria:

  • Age less than 21 years old
  • Pregnancy
  • Allergy, contraindication or intolerance to Nitrofurantoin
  • Do not speak English
  • Dependent on trans-urethral catheter to accomplish voiding preoperatively
  • Undergoing interstim device placement, urethral diverticulum surgery or fistula surgery
  • Sustain intraoperative urinary tract injury requiring postoperative catheterization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450800

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Cindy Amundsen, MD Duke University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01450800     History of Changes
Other Study ID Numbers: Pro00025269, 3913577
Study First Received: October 10, 2011
Results First Received: September 30, 2013
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
urinary tract infection
gynecologic surgery
post-operative complications
nitrofurantoin

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Nitrofurantoin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on August 20, 2014