UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections; Incontinence
• Intervention / Treatment: Dietary supplement: Cranberry extract capsules; Dietary supplement: Placebo capsule

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 Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Capsules	Dietary supplement: Placebo capsule; Participants in the placebo arm will receive placebo capsules.
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Lieschen Quiroz, MD, University of Oklahoma

Publications and helpful links

General Publications

• Temtanakitpaisan T, Buppasiri P, Lumbiganon P, Laopaiboon M, Rattanakanokchai S. Prophylactic antibiotics for preventing infection after continence surgery in women with stress urinary incontinence. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD012457. doi: 10.1002/14651858.CD012457.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2019
• Primary Completion (Actual): January 22, 2023
• Study Completion (Actual): January 22, 2023

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Tract Infections
• Other Study ID Numbers: 9977

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No