Clinical trial NCT02996981: Cranberry Effect on Urinary Tract Infections
Official title: Do Cranberry Juice Capsules Reduce the Risk of Urinary Tract Infections in Patients With Indwelling Urinary Catheters Following Urogynecologic Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 167
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent pelvic floor gynecologic surgery (for the indication of pelvic organ prolapse or stress urinary incontinence) performed by a physician at Cincinnati Urogynecology associates, TriHealth Inc between April 2015 and September 2015, and April 2016 and September 2016

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Incidence of UTI
timeFrame: within 6 weeks postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Rachel Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shatkin-Margolis A, Warehime J, Pauls RN. Cranberry Supplementation Does Not Reduce Urinary Tract Infections in Patients With Indwelling Catheters After Pelvic Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2018 Mar/Apr;24(2):130-134. doi: 10.1097/SPV.0000000000000507.