UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
Primary Purpose
Urinary Tract Infections, Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cranberry extract capsules
Placebo capsule
Sponsored by

About this trial
This is an interventional prevention trial for Urinary Tract Infections
Eligibility Criteria
Inclusion Criteria:
- Women undergoing elective incontinence procedures that does not involve fistula repair or vaginal mesh excision
Exclusion Criteria:
- Women undergoing incontinence procedures involving fistula repair or vaginal mesh excision
Sites / Locations
- University of Oklahoma
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cranberry Extract Capsules
Placebo Capsules
Arm Description
36mg of proanthocyanidins in cranberry capsules
Outcomes
Primary Outcome Measures
Urine culture based on type of symptoms
A urine culture to determine UTI will be performed based on symptoms such as urgency, frequency, dysuria or hematuria following incontinence surgery, as reported by the participant.
Secondary Outcome Measures
Duration of symptoms
If symptoms are reported, the participant will be asked long they have had these symptoms since surgery.
Full Information
NCT ID
NCT03898310
First Posted
February 27, 2019
Last Updated
June 12, 2023
Sponsor
University of Oklahoma
1. Study Identification
Unique Protocol Identification Number
NCT03898310
Brief Title
UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
Official Title
UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
January 22, 2023 (Actual)
Study Completion Date
January 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The risk of urinary tract infection (UTI) following female incontinence surgery ranges between 6-48%. The literature has shown mixed results of the therapeutic efficacy of cranberry extract to prevent UTI in females, with some promising preliminary work in the prevention of UTI's following gynecologic surgery. The researchers will conduct a study of the effect of cranberry extracts on preventing urinary tract infections following mid urethral slings, which are the most common urinary incontinence procedures.
Detailed Description
The researchers are going to perform a randomized, double-blind, placebo controlled trial of cranberry extract capsules for the prevention of UTI following incontinence surgery. They will recruit patients from a single hospital in a 24 month duration. Eligible participants are women undergoing elective incontinence procedures that does not involve fistula repair or vaginal mesh excision. The therapeutic regimen will be Theracran One cranberry capsules containing 36mg of proanthocyanidins and placebo cranberry capsules and placebo capsules. Both will be supplied by Theralogix Nutritional Sciences.
Following randomization into treatment or placebo therapy, the participants will be asked to start prophylaxis on day of surgery for a duration of six weeks. The researchers will collect urine specimen via catheter upon insertion in the operating room. At time of discharge, the researchers will provide all participants with capsules for six weeks of the assigned regimen until they are seen for their post-operative visit.
Participants will be told to contact research staff immediately and collect a urine specimen should they experience urinary symptoms consistent with UTI. The researchers will administer a brief structured interview regarding type and duration of symptoms and refer for treatment when necessary. Urine will be cultured using standard microbiologic techniques for the presence of uropathogens at one clinical laboratory.
Participants will be asked to complete a self-administered questionnaire at the two week post-operative clinic visit and again at six weeks. At study exit, the researchers will collect capsule bottles to ensure and assess compliance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Incontinence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
141 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cranberry Extract Capsules
Arm Type
Experimental
Arm Description
36mg of proanthocyanidins in cranberry capsules
Arm Title
Placebo Capsules
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Cranberry extract capsules
Intervention Description
Participants in the treatment arm will receive cranberry extract capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo capsule
Intervention Description
Participants in the placebo arm will receive placebo capsules.
Primary Outcome Measure Information:
Title
Urine culture based on type of symptoms
Description
A urine culture to determine UTI will be performed based on symptoms such as urgency, frequency, dysuria or hematuria following incontinence surgery, as reported by the participant.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Duration of symptoms
Description
If symptoms are reported, the participant will be asked long they have had these symptoms since surgery.
Time Frame
2 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women undergoing elective incontinence procedures that does not involve fistula repair or vaginal mesh excision
Exclusion Criteria:
Women undergoing incontinence procedures involving fistula repair or vaginal mesh excision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lieschen Quiroz, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35349162
Citation
Temtanakitpaisan T, Buppasiri P, Lumbiganon P, Laopaiboon M, Rattanakanokchai S. Prophylactic antibiotics for preventing infection after continence surgery in women with stress urinary incontinence. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD012457. doi: 10.1002/14651858.CD012457.pub2.
Results Reference
derived
Learn more about this trial
UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
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