Cincinnati, Ohio 45220


Purpose:

This study is randomized double-blinded placebo-controlled trial to access oral Methenamine Hippurate (MH) in combination with cranberry capsules is superior to cranberry capsules alone in prevention of UTI in patients with transient post-operative urinary retention requiring a Foley catheter after pelvic reconstructive surgery.


Study summary:

Urinary tract infections (UTIs) are one of the most common bacterial infections in women. It is estimated that 1.6 billion dollars are spent on UTI treatment each year. Antibiotics have been the mainstay of treatment of UTIs, however frequent use has increased the prevalence of antibiotic resistant organisms. Therefore, focus has shifted to non-antibiotic therapy for UTI prophylaxis. Methenamine Hippurate (MH) has been studied for decades due to its potential role in prevention of UTI. While not technically an antibiotic, MH works via its bacteriostatic action in the bladder. Benefits of MH are the lack of development of resistance, and the selective nature of this drug to the urinary system only. However, MH is best used in conjunction with an acidifying agent to increase its bioavailability (such as cranberry capsules or other acidic products). The usage of MH has been studied in various populations, has been seen to be effective in short-term catheterization. Usage of cranberry as prophylaxis for UTI is controversial; however, results have been favorable in the post-operative gynecological population. Post-operative urinary retention (POUR) occurs frequently in patients who undergo incontinence and pelvic prolapse surgery. Although the definition of POUR can vary between clinicians, it is reported as 2.5-24% to as high as 43% after tension-free transvaginal mesh sling placement. This population is at also at high risk for UTI due to advanced age and menopausal status. Moreover, using a catheter longer than 2 days incurs a 2-fold increased risk of development of UTI with an estimated 5% increase in bacteriuria each day of catheterization. In hopes to decrease the overuse of antibiotics and decrease the likelihood of antibiotic resistance, we propose that the use of MH and cranberry can reflect a potential benefit in this population of short-term indwelling Foley catheter use and help reduce the incidence of post-operative UTI after pelvic surgery. The patients will then be randomized to either receive cranberry capsules and placebo OR cranberry capsules and Methenamine Hippurate.


Criteria:

Inclusion Criteria: - Patients who undergo major pelvic organ prolapse surgery that are diagnosed with POUR via failed retrograde void trial and require an indwelling Foley catheter upon hospital discharge. Exclusion Criteria: - Unwillingness to participate in the study - Inability to understand English - Pregnant women - Patient personal history of nephrolithiasis, urogenital anomaly, neurogenic bladder, chronic renal insufficiency (GFR <60 ml/min/1.73 m² or serum creatinine level >1.03 for >3months), sarcoidosis, and severe hepatic insufficiency - Currently (prior 3 months) undergoing medical management for recurrent UTI or interstitial cystitis - Active urinary tract infection - Patient history of taking Warfarin (Coumadin) - Intraoperative bladder injury or cystotomy - Physical or mental impairment that would affect the subject's ability to take medications daily or fill out questionnaires - Reported allergy to any of the ingredients in the cranberry, MH, or placebo pill


Study is Available At:


Original ID:

18-115


NCT ID:

NCT03818321


Secondary ID:


Study Acronym:


Brief Title:

Urinary Track Infection Prevention After Urogynecological Surgery


Official Title:

Methenamine Hippurate With Cranberry Capsules Versus Cranberry Capsules Alone for UTI Prevention in a Short-term Indwelling Foley Catheter Population After Urogynecological Surgery: A Double-Blinded Randomized Controlled Trial


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

TriHealth Inc.


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

208


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Rachel Pauls, MD
Principal Investigator
TriHealth - Cincinnati Urogynecology Associates
Primary Contact:Eunsun Yook, MS
513-463-4300
eunsun_yook@trihealth.com
Backup Contact:Tiffanie Tam, MD
513-463-4300
Tiffanie_Tam@trihealth.com

Study Dates

Start Date:June 17, 2019
Completion Date:July 2020
Completion Type:Anticipated
Primary Completion Date:July 2020
Primary Completion Type:Anticipated
Verification Date:January 2019
Last Changed Date:July 12, 2019
First Received Date:January 23, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Incidence of urinary track infection (UTI)
Time Frame:From surgery to one week post-op visit, approximately 1 week post surgery
Safety Issues:False
Description:Incidence of UTIs will be diagnosed at one week post-op visit.

Study Interventions

Intervention Type:Drug
Name:Methenamine Hippurate 1 g tablet
Description:Methenamine Hippurate (study drug) is an FDA approved medication in the prevention of UTI. Methenamine Hippurate 1g contains Hippuric acid salt of Methenamine (hexamethylene tetramine), Magnesium Stearate, Povidone, Saccharin Sodium, FD&C Yellow No. 5 (tartrazine) (www.iodine.com/drug/hiprex/fda-package-insert).
Arm Name:Methenamine Hippurate with Cranberry
Intervention Type:Drug
Name:Placebo tablet
Description:Placebo is a tablet that will be provided to you that looks like the study drug but does not contain any medication. These pills are comprised of gelatin and minimal amounts of lactose powder. The pills are designed to have no effect on the patient.
Arm Name:Placebo with Cranberry

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo with Cranberry
Description:Subjects will be instructed to take Placebo tablet (1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days. Cranberry capsules were incorporated into the standard practice of Cincinnati Urogynecology Associates, TriHealth Inc in mid-March 2016.
Study Arm Type:Experimental
Arm Name:Methenamine Hippurate with Cranberry
Description:Subjects will be instructed to take Methenamine Hippurate 1 g tablet ( 1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:TriHealth Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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