UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery

Urinary Tract Infections Clinical Trial

Official title:

UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898310
• Other study ID #: 9977
• Status: Completed
• Phase: N/A
• Start date: February 5, 2019
• Est. completion date: January 22, 2023

Study information

• Verified date: June 2023
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: January 22, 2023
• Est. primary completion date: January 22, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Incontinence
• Urinary Tract Infections

Intervention

Dietary Supplement:
• Cranberry extract capsules
Participants in the treatment arm will receive cranberry extract capsules.
• Placebo capsule
Participants in the placebo arm will receive placebo capsules.

Locations

Country	Name	City	State
United States	University of Oklahoma	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of symptoms	If symptoms are reported, the participant will be asked long they have had these symptoms since surgery.	2 weeks