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NCT02996981 Clinical Trial

Cranberry Effect on Urinary Tract Infections

Urinary Tract Infections Clinical Trial

Official title:
Do Cranberry Juice Capsules Reduce the Risk of Urinary Tract Infections in Patients With Indwelling Urinary Catheters Following Urogynecologic Surgery?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02996981
Other study ID # 16-087
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 21, 2016
Est. completion date December 2017

Study information
Verified date October 2022
Source TriHealth Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a retrospective chart review using Electronic Privacy Identification Center (EPIC) database to determine if the addition of cranberry juice capsules to our discharge medication regimen for patients discharged home with an indwelling urinary catheter following pelvic floor gynecology surgery reduced the incidence of UTI.

Description:

The incidence of urinary tract infection (UTI) in women undergoing pelvic floor gynecologic surgery is high, ranging from 10-64%. A recent randomized trial showed that cranberry juice capsules significantly reduced the incidence of UTI in patients undergoing elective gynecologic surgery (19% vs 38%; odds ratio 0.38 with confidence interval 0.19-0.79). Cranberry juice capsules were incorporated into the standard practice of Cincinnati Urogynecology Associates, TriHealth Inc in mid-March 2016. Currently, all patients who undergo pelvic floor gynecologic surgery and are discharged from the hospital with an indwelling urinary catheter postoperatively are prescribed cranberry juice capsules to reduce the risk of UTI. The purpose of this study is to determine if the addition of cranberry juice capsules to the discharge medication regimen for patients discharged home with an indwelling urinary catheter following pelvic floor gynecology surgery significantly reduced the incidence of UTI, compared to a separate cohort that did not have cranberry prescribed.

Recruitment information / eligibility
Status Completed
Enrollment 167
Est. completion date December 2017
Est. primary completion date July 14, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Underwent pelvic floor gynecologic surgery between April 2015 and September 2015, and April 2016 and September 2016 - Required indwelling urinary catheter use upon discharge from the hospital. Exclusion Criteria: - Intraoperative bladder injury, fistula repair, urethral diverticulectomy, or any other need for prolonged catheterization - Complications in the 2 weeks following surgery requiring reoperation and subsequent catheter use - Allergy to cranberry or its components - Failure to present for both the two-week and six-week postoperative office visit

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
TriHealth Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary The Incidence of UTI within 6 weeks postoperative
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