Preventing Urinary Tract Infection Post-Surgery (PUPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01346774|
Recruitment Status : Completed
First Posted : May 3, 2011
Results First Posted : June 10, 2015
Last Update Posted : June 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infection||Drug: Cranberry powder capsules Drug: Placebo powder capsules||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase II Efficacy of Cranberry Powder in Preventing Catheter-associated Urinary Tract Infection Post Elective Gynecological Surgery|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Cranberry powder capsules
TheraCran® cranberry: based upon proanthocyanidin content, the four cranberry capsules are equivalent to two 8-ounce servings of cranberry juice.
Participants were directed to take two capsules by mouth twice each day (once in the morning and once in the evening) starting at time of discharge for 4-6 weeks, or until their return for their post-operative doctor's visit. Participants were instructed to drink an 8 oz glass of water while taking the capsule with or without food.
Drug: Cranberry powder capsules
2 cranberry powder capsules twice a day
Other Name: TheraCran
Placebo Comparator: Placebo capsules
Placebo: participants were directed to take two capsules by mouth twice each day (once in the morning and once in the evening) starting at time of discharge for 4-6 weeks, or until their return for their post-operative doctor's visit. Participants were instructed to drink an 8 oz glass of water while taking the capsule with or without food.
Drug: Placebo powder capsules
2 placebo capsules twice a day
- Participants With Clinically-diagnosed and Treated UTI's. [ Time Frame: From surgery to post-op visit, approximately 6 weeks post surgery ]The primary endpoint was the number of participants who were clinically-diagnosed and treated for UTI whether or not results from a urine culture were available. All UTI's were confirmed via medical records.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346774
|United States, Michigan|
|Urogynecology Clinic; University of Michigan|
|Ann Arbor, Michigan, United States, 48103|
|Principal Investigator:||Betsy Foxman, PhD||University of Michigan|