Urinary Track Infection Prevention After Urogynecological Surgery
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| ClinicalTrials.gov Identifier: NCT03818321 |
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Recruitment Status :
Completed
First Posted : January 28, 2019
Results First Posted : November 14, 2022
Last Update Posted : November 14, 2022
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| 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 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 185 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 : | June 17, 2019 |
| Actual Primary Completion Date : | July 1, 2021 |
| Actual Study Completion Date : | July 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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). |
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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. |
- Incidence of Urinary Track Infection (UTI) [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
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): NCT03818321
| United States, Ohio | |
| Cincinnati Urogynecology Associates | |
| Cincinnati, Ohio, United States, 45220 | |
| Principal Investigator: | Rachel Pauls, MD | TriHealth - Cincinnati Urogynecology Associates |
Documents provided by TriHealth Inc.:
| Responsible Party: | TriHealth Inc. |
| ClinicalTrials.gov Identifier: | NCT03818321 |
| Other Study ID Numbers: |
18-115 |
| First Posted: | January 28, 2019 Key Record Dates |
| Results First Posted: | November 14, 2022 |
| Last Update Posted: | November 14, 2022 |
| Last Verified: | October 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Infections Urinary Tract Infections Urinary Retention Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical Urologic Diseases Urination Disorders |
Methenamine Methenamine hippurate Methenamine mandelate Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Anti-Bacterial Agents |