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UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery

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University of Oklahoma

キーワード

概要

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.

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

Urinary Tract Infections
Incontinence

介入/治療

Dietary Supplement: Cranberry Extract Capsules

Dietary Supplement: Placebo Capsules

段階

-

アームグループ

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]

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.

二次的な結果の測定

1. Duration of symptoms [2 weeks]

If symptoms are reported, the participant will be asked long they have had these symptoms since surgery.

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