UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
Paskutinį kartą patikrinta: | 03/31/2020 |
Pirmasis pateikimas: | 02/26/2019 |
Numatytas registravimas pateiktas: | 03/27/2019 |
Pirmas paskelbtas: | 03/31/2019 |
Paskutinis atnaujinimas pateiktas: | 04/08/2020 |
Paskutinis atnaujinimas paskelbtas: | 04/09/2020 |
Faktinė studijų pradžios data: | 02/04/2019 |
Numatoma pirminio užbaigimo data: | 01/30/2021 |
Numatoma studijų užbaigimo data: | 01/30/2021 |
Būklė ar liga
Intervencija / gydymas
Dietary Supplement: Cranberry Extract Capsules
Dietary Supplement: Placebo Capsules
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
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 Capsules Participants in the placebo arm will receive placebo capsules. |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 18 Years Į 18 Years |
Tinkamos studijoms lytys | Female |
Priima sveikus savanorius | Taip |
Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. Urine culture based on type of symptoms [2 weeks]
Antrinės rezultatų priemonės
1. Duration of symptoms [2 weeks]