Ignite Creation Date:
2024-05-06 @ 3:43 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02358993
Status:
COMPLETED
Last Update Posted:
2022-02-25
First Post:
2015-02-03
Brief Title:
Short-course Methenamine Hippurate for Prevention of Post-operative UTI
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
The Efficacy and Cost-effectiveness of a 24-hour Course of metheNamine Hippurate for Preventing Post-Operative Urinary Tract Infection
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NO-UTI
Brief Summary:
The investigators will determine the efficacy of an innovative short regimen of methenamine hippurate on prevention of post-operative UTI in patients requiring short-term catheterization after pelvic reconstructive surgery through a single-blind randomized controlled trial Primary outcome will be the rate of symptomatic UTI within 3 weeks of catheter removal The investigators will study cost-effectiveness antibiotic resistance profiles and adverse drug effects Findings may reduce antibiotic use and nosocomial UTIs
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None