UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
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|ClinicalTrials.gov Identifier: NCT03898310|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : June 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections Incontinence||Dietary Supplement: Cranberry extract capsules Dietary Supplement: Placebo capsule||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||174 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery|
|Actual Study Start Date :||February 5, 2019|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2020|
Experimental: Cranberry Extract Capsules
36mg of proanthocyanidins in cranberry capsules
Dietary Supplement: Cranberry extract capsules
Participants in the treatment arm will receive cranberry extract capsules.
|Placebo Comparator: Placebo Capsules||
Dietary Supplement: Placebo capsule
Participants in the placebo arm will receive placebo capsules.
- Urine culture based on type of symptoms [ Time Frame: 2 weeks ]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.
- Duration of symptoms [ Time Frame: 2 weeks ]If symptoms are reported, the participant will be asked long they have had these symptoms since surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898310
|Contact: Christy Zornes, MHR||4052718001 ext 48137||Christy-Zornes@ouhsc.edu|
|United States, Oklahoma|
|University of Oklahoma||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Christy Zornes 405-271-8001 ext 48137 Christy-Zornes@ouhsc.edu|
|Principal Investigator: Lieschen Quiroz, MD|
|Principal Investigator:||Lieschen Quiroz, MD||University of Oklahoma|