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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Duke University Identifier:
First received: October 10, 2011
Last updated: April 1, 2013
Last verified: March 2013

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
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 infection [ Time Frame: three weeks post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ] [ Designated as safety issue: No ]
    We will examine risk of UTI as related to vaginal estrogen therapy, history of recurrent UTIs, preoperative PVR, preoperative UTI treatment, Creatinine Clearance, sling as part of surgery, postoperative void trial PVR, total postoperative catheter days, postoperative catheter type, total days of use of study drug

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

Enrollment: 159
Study Start Date: August 2011
Estimated Study Completion Date: January 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nitrofurantoin Drug: Nitrofurantoin
Nitrofurantoin 100mg po daily to be taken every day the patient uses a catheter for up to one week post-operatively
Other Name: Macrobid, Macrodantin
Placebo Comparator: Placebo Drug: Nitrofurantoin
Nitrofurantoin 100mg po daily to be taken every day the patient uses a catheter for up to one week post-operatively
Other Name: Macrobid, Macrodantin

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

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
Please refer to this study by its identifier: NCT01450800

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


Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Duke University Identifier: NCT01450800     History of Changes
Other Study ID Numbers: Pro00025269, 3913577
Study First Received: October 10, 2011
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Anti-Infective Agents, Urinary
Renal Agents processed this record on April 16, 2014