UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery

Conditions
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Urinary Tract Infections, Incontinence

Intervention / Treatment
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* Dietary Supplement: Cranberry extract capsules
* Dietary Supplement: Placebo capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cranberry Extract Capsules<br>36mg of proanthocyanidins in cranberry capsules | Dietary Supplement: Cranberry extract capsules<br>* Participants in the treatment arm will receive cranberry extract capsules.<br>|
| Placebo Comparator: Placebo Capsules<br> | Dietary Supplement: Placebo capsule<br>* Participants in the placebo arm will receive placebo capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine culture based on type of symptoms | 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. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of symptoms | If symptoms are reported, the participant will be asked long they have had these symptoms since surgery. | 2 weeks |