Urinary Track Infection Prevention After Urogynecological Surgery



Status:Not yet recruiting
Conditions:Other Indications, Infectious Disease, Women's Studies, Urology, Urology, Urinary Tract Infections
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology, Other, Reproductive
Healthy:No
Age Range:18 - 80
Updated:3/15/2019
Start Date:May 2019
End Date:July 2020
Contact:Eunsun Yook, MS
Email:eunsun_yook@trihealth.com
Phone:513-463-4300

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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

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.

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.

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
We found this trial at
1
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Cincinnati, Ohio 45220
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Cincinnati, OH
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