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UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery

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ClinicalTrials.gov Identifier: NCT03898310
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Incontinence Dietary Supplement: Cranberry extract capsules Dietary Supplement: Placebo capsule Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 capsule
Participants in the placebo arm will receive placebo capsules.




Primary Outcome Measures :
  1. Urine culture based on type of symptoms [ Time Frame: 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 :
  1. Duration of symptoms [ Time Frame: 2 weeks ]
    If symptoms are reported, the participant will be asked long they have had these symptoms since surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898310


Contacts
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Contact: Christy Zornes, MHR 4052718001 ext 48137 Christy-Zornes@ouhsc.edu

Locations
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United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Christy Zornes    405-271-8001 ext 48137    Christy-Zornes@ouhsc.edu   
Principal Investigator: Lieschen Quiroz, MD         
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Lieschen Quiroz, MD University of Oklahoma

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03898310     History of Changes
Other Study ID Numbers: 9977
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Tract Infections
Infection
Urologic Diseases