Ignite Creation Date:
2024-05-06 @ 12:39 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03818321
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2019-01-23
Brief Title:
Urinary Track Infection Prevention After Urogynecological Surgery
Sponsor:
TriHealth Inc
Organization:
TriHealth Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-10
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:
None
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
Detailed Description:
Urinary tract infections UTIs are one of the most common bacterial infections in women It is estimated that 16 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 25-24 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
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 25-24 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None