Urinary Track Infection Prevention After Urogynecological Surgery

Sponsor

TriHealth Inc. (Other)

Overall Status

Recruiting

CT.gov ID

NCT03818321

Collaborator

(none)

208

Enrollment

Location

Arms

29.5

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections Urinary Retention Postoperative Pelvic Organ Prolapse	Drug: Methenamine Hippurate 1 g tablet Drug: Placebo tablet	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

208 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

This is randomized double-blinded placebo-controlled trial, and both patients and investigators are blinded. However, a research nurse will not be blinded to the group allocation, and the research nurse will order each patient's medication to the inpatient pharmacy based on the study randomization scheme.

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jun 17, 2019

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methenamine Hippurate with Cranberry 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.	Drug: Methenamine Hippurate 1 g tablet 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).
Placebo Comparator: Placebo with Cranberry 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.	Drug: Placebo tablet 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

Intervention/Treatment

Experimental: Methenamine Hippurate with Cranberry

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.

Drug: Methenamine Hippurate 1 g tablet

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).

Placebo Comparator: Placebo with Cranberry

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.

Drug: Placebo tablet

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.

Outcome Measures

Primary Outcome Measures

Incidence of urinary track infection (UTI) [From surgery to one week post-op visit, approximately 1 week post surgery]
Incidence of UTIs will be diagnosed at one week post-op visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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