Preventing Urinary Tract Infection Post-Surgery (PUPS)

This study has been completed.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Information provided by (Responsible Party):
Betsy Foxman, University of Michigan
ClinicalTrials.gov Identifier:
NCT01346774
First received: April 29, 2011
Last updated: May 26, 2015
Last verified: May 2015
Results First Received: April 28, 2015  
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
Condition: Urinary Tract Infection
Interventions: Drug: Cranberry powder capsules
Drug: Placebo powder capsules

  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
Participants were recruited at their preoperative appointment for gynecological surgery. At enrollment they completed a questionnaire about their history and signed an informed consent form. Participants were not assigned to a treatment arm until the day of their surgery.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

If a participant's surgery was canceled or she failed to complete her enrollment questionnaire she was not assigned to a treatment arm.

200 women were consented, 160 were randomly assigned to treatment (80 cranberry, 80 placebo).


Reporting Groups
  Description
Cranberry Capsules Cranberry powder: 2 cranberry powder capsules twice a day
Placebo Placebo powder: 2 placebo powder capsules twice a day

Participant Flow:   Overall Study
    Cranberry Capsules     Placebo  
STARTED     80     80  
COMPLETED     67     63  
NOT COMPLETED     13     17  
Did not take a single dose                 6                 4  
Lost to Follow-up                 3                 4  
Withdrawal by Subject                 1                 4  
Protocol Violation                 2                 3  
Adverse Event                 1                 2  



  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.
No text entered.

Reporting Groups
  Description
Cranberry Capsules Cranberry powder: 2 cranberry powder capsules twice a day
Placebo Placebo powder: 2 placebo powder capsules twice a day
Total Total of all reporting groups

Baseline Measures
    Cranberry Capsules     Placebo     Total  
Number of Participants  
[units: participants]
  80     80     160  
Age, Customized  
[units: participants]
     
18 - 60 years     47     48     95  
> 60 years     33     32     65  
Gender  
[units: participants]
     
Female     80     80     160  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     2     1     3  
Not Hispanic or Latino     75     77     152  
Unknown or Not Reported     3     2     5  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     4     5     9  
White     69     72     141  
More than one race     5     3     8  
Unknown or Not Reported     2     0     2  
Region of Enrollment  
[units: participants]
     
United States     80     80     160  
Experienced a UTI in the past 12 mo [1]
[units: participants]
  18     19     37  
Ever experienced UTI in life [2]
[units: participants]
  49     50     99  
Reasons for surgery [3]
[units: participants]
     
Fibroids     11     9     20  
Pelvic organ prolapse     51     56     107  
Stress urinary incontinence     21     23     44  
Chronic pelvic pain     2     3     5  
Endometriosis     0     2     2  
Abnormal uterine bleeding     11     6     17  
Adnexal mass     4     4     8  
Other     9     18     27  
Type of Surgery [4]
[units: participants]
     
Urinary incontinence operation     24     24     48  
Prolapse/reconstructive     52     58     110  
Hysterectomy/other extirpative     35     42     77  
Other     4     4     8  
[1] Participant has experienced UTI in the 12 months prior to her gynecologic surgery.
[2] Participant has experienced UTI at least once in her lifetime prior to her gynecologic surgery.
[3] Categories are not mutually exclusive. Participants may have had more than one reason for surgery.
[4] Categories are not mutually exclusive; participants may have required more than one type of surgery.



  Outcome Measures

1.  Primary:   Participants With Clinically-diagnosed and Treated UTI's.   [ Time Frame: From surgery to post-op visit, approximately 6 weeks post 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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Betsy Foxman, Hunein F. and Hilda Maassab Professor of Epidemiology
Organization: University of Michigan
phone: 734-764-5487
e-mail: bfoxman@umich.edu


Publications of Results:

Responsible Party: Betsy Foxman, University of Michigan
ClinicalTrials.gov Identifier: NCT01346774     History of Changes
Other Study ID Numbers: R21DK085290 ( US NIH Grant/Contract Award Number )
HUM00041108 ( Other Identifier: University of Michigan IRBMED )
Study First Received: April 29, 2011
Results First Received: April 28, 2015
Last Updated: May 26, 2015
Health Authority: United States: Food and Drug Administration