Cranberry Effect on Urinary Tract Infections

NCT02996981 | Completed Results

• 1 other identifier: 16-087
• Study Type: observational
• Target: 167
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• The Incidence of UTI

  within 6 weeks postoperative

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Related Publications (1)

• 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.

  PMID: 29474286 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Rachel Pauls
• Organization: TriHealth Inc.

Rachel_Pauls@trihealth.com

513-463-4300

Study Officials

• Rachel Pauls, MD

  TriHealth - Cincinnati Urogynecology Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: November 21, 2016
• Primary Completion: July 14, 2017
• Study Completion: December 1, 2017
• Last Updated: August 31, 2023
• Results First Posted: August 31, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share