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Cranberry Effect on Urinary Tract Infections

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02996981
Enrollment
167
Registered
2016-12-19
Start date
2016-11-21
Completion date
2017-12-31
Last updated
2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

TriHealth Inc.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The Incidence of UTIwithin 6 weeks postoperative

Participant flow

Participants by arm

ArmCount
Cranberry Group
Patients underwent pelvic floor gynecologic surgery performed by a physician at Cincinnati Urogynecology Associates, TriHealth Inc between April 2016 and September 2016 and discharged home with an indwelling urinary catheter following the surgery. This group of people had cranberry juice capsules prescribed.
96
No Cranberry Group
Patients underwent pelvic floor gynecologic surgery performed by a physician at Cincinnati Urogynecology Associates, TriHealth Inc between April 2015 and September 2015. This group of people did not have cranberry juice capsules prescribed.
71
Total167

Baseline characteristics

CharacteristicCranberry GroupNo Cranberry GroupTotal
Age, Continuous60.28 years
STANDARD_DEVIATION 14.1
59.62 years
STANDARD_DEVIATION 15.29
60.00 years
STANDARD_DEVIATION 14.57
Race/Ethnicity, Customized
African American
6 Participants4 Participants10 Participants
Race/Ethnicity, Customized
Asian
1 Participants1 Participants2 Participants
Race/Ethnicity, Customized
Hispanic
3 Participants0 Participants3 Participants
Race/Ethnicity, Customized
Other
0 Participants2 Participants2 Participants
Race/Ethnicity, Customized
White
86 Participants64 Participants150 Participants
Region of Enrollment
United States
96 participants71 participants167 participants
Sex: Female, Male
Female
96 Participants71 Participants167 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 960 / 71
other
Total, other adverse events
0 / 960 / 71
serious
Total, serious adverse events
0 / 960 / 71

Outcome results

Primary

The Incidence of UTI

Time frame: within 6 weeks postoperative

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cranberry GroupThe Incidence of UTI66 Participants
No Cranberry GroupThe Incidence of UTI54 Participants
p-value: 0.299Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026