UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery

Not Applicable

Completed

• Conditions: Incontinence; Urinary Tract Infections
• Interventions: Dietary Supplement: Placebo capsule; Dietary Supplement: Cranberry extract capsules

• Registration Number: NCT03898310
• Lead Sponsor: University of Oklahoma

Brief Summary

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

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 Timeline

• Study Start: 2019-02-05
• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-04-01
• Primary Completion: 2023-01-22
• Study Completion: 2023-01-22
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Capsules	Placebo capsule	-
Cranberry Extract Capsules	Cranberry extract capsules	36mg of proanthocyanidins in cranberry capsules

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Duration of symptoms	2 weeks	If symptoms are reported, the participant will be asked long they have had these symptoms since surgery.

Trial Locations

Locations (1)

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States