Ignite Creation Date:
2024-05-06 @ 12:57 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03898310
Status:
COMPLETED
Last Update Posted:
2023-06-13
First Post:
2019-02-27
Brief Title:
UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 UTIs 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None