UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
キーワード
概要
説明
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.
日付
最終確認済み: | 03/31/2020 |
最初に提出された: | 02/26/2019 |
提出された推定登録数: | 03/27/2019 |
最初の投稿: | 03/31/2019 |
最終更新が送信されました: | 04/08/2020 |
最終更新日: | 04/09/2020 |
実際の研究開始日: | 02/04/2019 |
一次完了予定日: | 01/30/2021 |
研究完了予定日: | 01/30/2021 |
状態または病気
介入/治療
Dietary Supplement: Cranberry Extract Capsules
Dietary Supplement: Placebo Capsules
段階
アームグループ
腕 | 介入/治療 |
---|---|
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. |
適格基準
研究の対象となる年齢 | 18 Years に 18 Years |
研究に適格な性別 | Female |
健康なボランティアを受け入れる | はい |
基準 | 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 |
結果
主な結果の測定
1. Urine culture based on type of symptoms [2 weeks]
二次的な結果の測定
1. Duration of symptoms [2 weeks]