Short-course Methenamine Hippurate for Prevention of Post-operative UTI (NO-UTI)
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| ClinicalTrials.gov Identifier: NCT02358993 |
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Recruitment Status :
Completed
First Posted : February 9, 2015
Results First Posted : February 25, 2022
Last Update Posted : February 25, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Urinary Tract Infections Catheter-Related Infections | Drug: methenamine hippurate Drug: Ciprofloxacin | Not Applicable |
Prevention of post-operative urinary tract infections (UTI) is becoming important for both the individual patient and the health system. Complications of UTI include pyelonephritis and bacteremia, requiring hospitalization and parenteral antibiotics. Additionally, recurrent exposure to antibiotics commonly given for UTIs increases the risk of antibiotic resistance to uropathogens. UTIs also increase economic burdens on the health care system, with each episode costing nearly 600 dollars. UTIs associated with catheterization are particularly costly for hospitals, resulting in decreased hospital quality measures and lack of compensation.
This is particularly important after pelvic reconstructive surgery, as reported rates of UTI reach up to 20-25%. Urinary retention requiring short-term indwelling catheterization, common in these women, contributes to the risk of UTIs by increasing the risk of bacteriuria by 5-10% per day and through the dislodging of bacterial colonies during catheter removal. Balancing prevention and resistance and cost is key. A meta-analysis by Marschall et al indicated the benefit of a short dose of antibiotic prophylaxis at catheter removal in general post-surgical patients. However, data is lacking on the effects of daily antibiotic prophylaxis on resistance and cost.
A possible alternative to antibiotics presents itself in methenamine hippurate, a urinary antiseptic which forms formaldehyde in the presence of acidic urine. It is relatively inexpensive, and does not induce resistance in vivo. Prior studies have shown that daily use of methenamine can decrease the risk of post-operative UTI.
The purpose of our study was to investigate the efficacy of a short course of methenamine hippurate at catheter removal to that of a short course of ciprofloxacin in prevention of UTIs after short-term indwelling catheterization. Additionally, we investigated factors that influence post-operative UTIs, the rate of culture-proven UTIs after prophylaxis, the antibiotic resistance profile of those undergoing prophylaxis, and the cost effectiveness of prophylaxis.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 201 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Prevention |
| Official Title: | The Efficacy and Cost-effectiveness of a 24-hour Course of metheNamine Hippurate for Preventing Post-Operative Urinary Tract Infection |
| Actual Study Start Date : | December 2014 |
| Actual Primary Completion Date : | September 30, 2020 |
| Actual Study Completion Date : | September 30, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Methenamine
Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal.
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Drug: methenamine hippurate
A urinary antiseptic used for prevention of UTI
Other Name: Hiprex |
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Active Comparator: Ciprofloxacin
Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal.
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Drug: Ciprofloxacin
An antibiotic used for treatment and prevention of UTI
Other Name: Cipro |
- Treatment of Clinically Suspected UTI - Using Intent to Treat Analysis [ Time Frame: 3 weeks post-operative ]This is defined as any symptomatic UTI requiring treatment with antibiotics as determined by the development of 2 or more of the following symptoms, in the absence of vaginal symptoms: urinary frequency; urinary urgency; dysuria; fever over 38oC/100.4oF; suprapubic, flank, or back pain; and/or chills.
- Treatment of Clinically Suspected UTI - Per Protocol [ Time Frame: 3 weeks post-operative ]This is defined as any symptomatic UTI requiring treatment with antibiotics as determined by the development of 2 or more of the following symptoms, in the absence of vaginal symptoms: urinary frequency; urinary urgency; dysuria; fever over 38oC/100.4oF; suprapubic, flank, or back pain; and/or chills.
- Number of Participants With Culture-positive Symptomatic UTI [ Time Frame: 3 weeks post-operative ]All patients will be encouraged to submit urine cultures prior to treatment, but this is not always possible. Amongst patients who undergo urine culture as part of standard of care for UTI, the rate of positive cultures will be identified.
- Antibiotic Resistance of Culture-positive Symptomatic UTI [ Time Frame: 3 weeks post-operative ]All patients who submit urine cultures that are positive will have sensitivities performed as per standard care. The prevalence of bacterial species and sensitivities will be collected
- Cost-effectiveness of Prophylaxis With Methenamine Hippurate for Prevention of Post-operative UTI Compared to Prophylaxis With Fluoroquinolones [ Time Frame: 3 weeks post-operative ]Routine costs of prevention of UTI with methenamine hippurate prophylaxis will be compared with costs of prevention of UTI with fluoroquinolone prophylaxis. We plan to capture costs for each direct medical service use, direct non-medical items, and indirect items related to post-operative UTIs in each arm of the trial.
- Prevalence of Side Effects [ Time Frame: within 24 hours of administration ]Adverse effects from the administration of methenamine and fluoroquinolones will be collected.
- Rate of UTI Consistent With NHSN Criteria [ Time Frame: 3 weeks post-operative ]We plan to analyze the prevalence of UTI in this population that meet the definitions of symptomatic UTI and catheter-associated UTI according to the National Healthcare Safety Network criteria.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- female;
- patients who are able to read and write English;
- 18 years of age or older;
- underwent surgery for pelvic organ prolapse, urinary incontinence, or both;
- require post-operative short-term transurethral catheterization for greater than 24 hours.
Exclusion Criteria:
- patients undergoing surgical intervention for sacral neuromodulation, or mesh excision;
- patients requiring long-term catheterization secondary to injury to the urinary tract;
- patients who pass their post-operative trial void and thus, do not require additional catheterization;
- patients requiring catheterization for less than 24 hours;
- pregnant patients;
- patients who are breast-feeding;
- allergy to methenamine hippurate or fluroquinolones (either ciprofloxacin or levofloxacin);
- impaired renal or hepatic function;
- pre-operative urinary retention;
- patients who are currently using sulfonamides;
- patients who have severe dehydration;
- patients using tizanidine;
- patients sensitive to quinolones class;
- patients using theophylline; patients with myasthenia gravis;
- patients with prolongation of QT interval.
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): NCT02358993
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Penn Presbyterian Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Pennsylvania Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Chestnut Hill Hospital | |
| Philadelphia, Pennsylvania, United States, 19118 | |
| Principal Investigator: | Christine M Chu, MD | University of Pennsylvania | |
| Study Director: | Lily Arya, MD, MS | University of Pennsylvania | |
| Principal Investigator: | Daniel Lee, MD | University of Pennsylvania |
Documents provided by University of Pennsylvania:
Publications:
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT02358993 |
| Other Study ID Numbers: |
820117 |
| First Posted: | February 9, 2015 Key Record Dates |
| Results First Posted: | February 25, 2022 |
| Last Update Posted: | February 25, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Urinary Tract Infections Catheter-Related Infections Pelvic Reconstructive Surgery Urogynecology |
Urinary catheterization Post-operative Infections Methenamine hippurate |
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Infections Communicable Diseases Urinary Tract Infections Catheter-Related Infections Disease Attributes Pathologic Processes Urologic Diseases Ciprofloxacin Methenamine hippurate Methenamine mandelate Methenamine |
Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors Anti-Infective Agents, Urinary Renal Agents |