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

  Hide Detailed Description

Detailed Description:

Study Population Participants will be recruited from all patients who are planning to undergo gynecologic surgery by an attending surgeon in the Division of Urogynecology at Duke University Medical Center (DUMC). After enrollment and randomization, the participants will take the study drug once daily to start on post-operative day one and continue until the participant has stopped catheterizing for up to one week after surgery. The participant will also complete a daily diary for one week after surgery to record any catheterization and any study drug or additional antibiotic medication taken. We will then follow patients for a total of three weeks after surgery to monitor for treatment for UTI. At three weeks after surgery the observation period for the participant is complete.

Sample Size Under the assumption of 80% power and an alpha error of 0.05, we would need 156 subjects to demonstrate a 66% reduction in risk of UTI (i.e. from 28% to 10%) in those undergoing prophylactic antibiotic treatment. Therefore, we aim to recruit a total of 175 participants to account for participant dropout.

Study Definitions For our study purposes, post-operative catheterization will be defined to include patients who are hospitalized post-operatively with an indwelling Foley catheter as well as patients discharged with either intermittent self-catheterization (ISC) or indwelling Foley catheter. The decision to catheterize will be determined by type of surgical procedure, need for inpatient stay and void trial results. Void trials will be conducted as follows: the bladder is backfilled with 300cc normal saline, the catheter is removed and the patient is prompted to void immediately and, after voiding is complete, a (PVR) post-void residual volume is measured. The patient passes the void trial if she voids over 200cc in total volume or if her PVR is less than 100cc.

Our primary outcome of treatment for UTI within the first three weeks after surgery is to be defined clinically. A patient will be considered to have received treatment for UTI if she receives any antibiotic therapy for clinically suspected or culture-proven urinary tract infection (i.e. empirically given upon development of urinary symptoms or prescribed based on urinalysis or urine culture results) within the first three weeks after surgery.

Data Collection Demographic characteristics, operative data and post-operative data will be collected. Prior to discharge after surgery all patients will undergo a void trial per standard procedure unless they receive an indwelling Foley catheter for overnight hospitalization. Post-operatively all subjects will be given a catheterization diary to record days of catheterization and days of antibiotic therapy. All subjects will be instructed to call our clinical office to report any urinary complaints and/or treatment for UTI. Information will be collected from electronic medical records regarding any office visits, urine cultures performed or treatment for UTI during this post-operative period. Data will be entered into a de-identified study database for analysis by the PI and study coordinator who will be blinded to participant randomization.

Subject Randomization and Blinding Study participants will be randomized to prophylactic treatment versus no treatment via a computerized randomization scheme by the IDS at the time of enrollment. Patients will be blinded to treatment by the utilization of placebo tablets.

Adverse Events Nitrofurantoin is FDA approved for the treatment of UTI. We will be using a prophylactic dose and will monitor for any adverse events. Adverse events will be reported per protocol. A safety monitoring designee will perform reviews on a designated basis throughout the study.

Study Costs There will be no additional cost to the patient for their participation in this study. No additional laboratory testing will be performed as a result of participation.

  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 July 26, 2014