UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
1 other identifier
interventional
141
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2019
CompletedFirst Submitted
Initial submission to the registry
February 27, 2019
CompletedFirst Posted
Study publicly available on registry
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2023
CompletedJune 13, 2023
June 1, 2023
4 years
February 27, 2019
June 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
2 weeks
Secondary Outcomes (1)
Duration of symptoms
2 weeks
Study Arms (2)
Cranberry Extract Capsules
EXPERIMENTAL36mg of proanthocyanidins in cranberry capsules
Placebo Capsules
PLACEBO COMPARATORInterventions
Participants in the treatment arm will receive cranberry extract capsules.
Participants in the placebo arm will receive placebo capsules.
Eligibility Criteria
You may qualify if:
- Women undergoing elective incontinence procedures that does not involve fistula repair or vaginal mesh excision
You may not qualify if:
- Women undergoing incontinence procedures involving fistula repair or vaginal mesh excision
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Related Publications (1)
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.
PMID: 35349162DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lieschen Quiroz, MD
University of Oklahoma
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2019
First Posted
April 1, 2019
Study Start
February 5, 2019
Primary Completion
January 22, 2023
Study Completion
January 22, 2023
Last Updated
June 13, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share