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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: December 23, 2016
Last verified: December 2016
Results First Received: September 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Urinary Tract Infection
Interventions: Drug: Nitrofurantoin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients who received postoperative transurethral catheterization after surgery for pelvic organ prolapse, urinary incontinence, or both by the Division of Urogynecology at Duke University Medical Center from 8/2011 through 2/2013 were identified, recruited and enrolled after providing written informed consent at a routine pre-operative visit.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization occurred within a few hours after surgery. Participants were excluded prior to randomization if they sustained intraoperative injury to the urinary tract requiring prolonged catheterization, or if they passed an immediate void trial on day of surgery (as these participants did not receive additional postoperative catheterization).

Reporting Groups
  Description
Nitrofurantoin Randomized to nitrofurantoin 100mg daily for each day of catheterization for up to 7 days
Placebo Randomized to placebo 1 tablet daily for each day of catheterization for up to 7 days

Participant Flow:   Overall Study
    Nitrofurantoin   Placebo
STARTED   82 [1]   81 [2] 
COMPLETED   81   78 
NOT COMPLETED   1   3 
Protocol Violation                1                3 
[1] 82 participants were randomized to nitrofurantoin
[2] 81 participants were randomized to placebo



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
163 participants were randomized, 82 to nitrofurantoin and 81 to placebo. Four randomized participants were excluded from the final analysis. One in the placebo group was excluded, as she had previously been included in the study during a prior surgery. Three participants in the nitrofurantoin group were excluded due to protocol deviations.

Reporting Groups
  Description
Nitrofurantoin Participants randomized to receive antibiotics instructed to take nitrofurantoin 100mg by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
Placebo Participants randomized to receive placebo instructed to take placebo 1 tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
Total Total of all reporting groups

Baseline Measures
   Nitrofurantoin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 82   81   163 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      58  70.7%      55  67.9%      113  69.3% 
>=65 years      24  29.3%      26  32.1%      50  30.7% 
Age 
[Units: Years]
Mean (Standard Deviation)
 57  (13)   57  (13)   57  (13) 
Gender 
[Units: Participants]
Count of Participants
     
Female      82 100.0%      81 100.0%      163 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   82   81   163 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Urinary Tract Infections   [ Time Frame: three weeks post-operative ]

2.  Secondary:   Other Risk Factors for UTI   [ Time Frame: 3 weeks following surgery ]

3.  Secondary:   Other Risk Factors for UTI   [ Time Frame: 3 weeks following surgery ]

4.  Secondary:   Other Risk Factors for UTI   [ Time Frame: 3 weeks following surgery ]

5.  Secondary:   Other Risk Factors for UTI   [ Time Frame: 3 weeks following surgery ]

6.  Secondary:   Other Risk Factors for UTI   [ Time Frame: 3 weeks following surgery ]

7.  Secondary:   Other Risk Factors for UTI   [ Time Frame: 3 weeks following surgery ]

8.  Secondary:   Other Risk Factors for UTI   [ Time Frame: 3 weeks following surgery ]

9.  Other Pre-specified:   Antibiotic Resistance to Macrobid   [ Time Frame: 6 weeks after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations of our study include recall bias and selection bias. Our findings have limited applicability to elderly patients undergoing pelvic reconstructive surgery.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Alexis Dieter
Organization: Duke University Medical Center
phone: 919-401-1006
e-mail: alexis.dieter@duke.edu


Publications:

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 ( Other Grant/Funding Number: Charles B Hammond Research Fund )
Study First Received: October 10, 2011
Results First Received: September 30, 2013
Last Updated: December 23, 2016