Ignite Creation Date:
2024-05-06 @ 8:22 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02727322
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2016-03-31
Brief Title:
Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery
Sponsor:
Halina M Zyczynski MD
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Trial of Nitrofurantoin Prophylaxis During Catheterization for Acute Postoperative Urinary Retention After Pelvic Reconstructive Surgery
Status:
COMPLETED
Status Verified Date:
2019-05
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:
The specific aim of this randomized double-blind placebo-controlled trial is to determine if extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of symptomatic urinary tract infection UTI compared with placebo for patients undergoing short term indwelling or clean intermittent self-catheterization CISC for acute postoperative urinary retention following pelvic organ prolapse andor urinary incontinence surgery
Consented patients who undergo urogenital surgery and fail their post-operative voiding trial will be randomized to either extended release nitrofurantoin 100mg or an identical appearing placebo capsule to be taken daily while performing CISC or while indwelling catheter is in place The primary outcome will be symptomatic and culture confirmed UTI within six weeks of surgery Secondary outcomes include adverse events associated with nitrofurantoin use and incidence of nitrofurantoin-resistant isolates from urine culture of symptomatic women
Primary and secondary outcomes will be evaluated with Student t test and chi squared or Fisher exact test as appropriate Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 33 to 13 with 80 power and a two-sided alpha of 005 and a 10 dropout rate we should recruit a total of 154 patients
Consented patients who undergo urogenital surgery and fail their post-operative voiding trial will be randomized to either extended release nitrofurantoin 100mg or an identical appearing placebo capsule to be taken daily while performing CISC or while indwelling catheter is in place The primary outcome will be symptomatic and culture confirmed UTI within six weeks of surgery Secondary outcomes include adverse events associated with nitrofurantoin use and incidence of nitrofurantoin-resistant isolates from urine culture of symptomatic women
Primary and secondary outcomes will be evaluated with Student t test and chi squared or Fisher exact test as appropriate Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 33 to 13 with 80 power and a two-sided alpha of 005 and a 10 dropout rate we should recruit a total of 154 patients
Detailed Description:
Urinary tract infections UTI occur frequently following surgery for urinary incontinence or pelvic organ prolapse POP with reported incidence up to 48 This high rate is frequently attributed to intraoperative factors such as manipulation of the genitourinary tract and instrumentation of the bladder and urethra as well as an approximately 50 rate of short term postoperative catheterization following urogynecologic surgery As American women have a 20 lifetime risk of surgery for POP or urinary incontinence the absolute number of women at risk for urinary infectious morbidity associated with these procedures is quite high
The substantial risk of UTI following POP or incontinence surgery combined with the well-established risk associated with catheterization leads many practitioners to prescribe oral antibiotics to women undergoing catheterization in the postoperative period However there is minimal Level I evidence to support or refute this practice The Infectious Disease Society of America IDSA Guideline acknowledges that prophylactic antibiotics have been shown to reduce UTI rates among patients using short term postoperative catheterization in randomized trials However they recommend against routine antibiotic prophylaxis use due to concerns regarding anti-microbial resistance cost and potential for adverse effects even among high risk groups including women undergoing urogynecologic surgery This recommendation is based on expert opinion given a paucity of trial data to guide clinical care
Nitrofurantoin is a commonly used antibiotic for UTI prophylaxis during catheterization is well-tolerated with few adverse effects and is known to have a very low rate of associated resistance After decades of use it remains active against the most common UTI pathogens that have gained resistance to other antimicrobials For example in the 2013 Magee-Womens Hospital Adult Antibiogram 98 of E-coli specimens were sensitive to Nitrofurantoin which has been consistent since at least 2007 The drug has a half-life of 20 minutes and 40 is concentrated in and excreted into the urine in a therapeutically unchanged form Thus it has minimal impact on vaginal and bowel flora Nitrofurantoin has been shown to reduce the incidence of positive urine cultures and symptomatic UTIs in women with a suprapubic catheter after pelvic organ prolapse andor urinary incontinence surgery No trials have evaluated nitrofurantoin prophylaxis for women using short term indwelling catheters or CISC following urogynecologic procedures
Given the large number of women at risk for urinary infectious morbidity associated with short term catheterization for acute urinary retention following POP andor incontinence surgery and the paucity of data on the impact of antibiotic prophylaxis in this setting we propose to demonstrate the efficacy of nitrofurantoin prophylaxis through an adequately-powered placebo-controlled trial Secondary outcomes will include adverse events associated with nitrofurantoin use and incidence of nitrofurantoin resistant bacterial isolates from urine culture
Primary Aim To determine if extended release nitrofurantoin administered daily to patients using indwelling or clean intermittent self-catheterization CISC after pelvic organ prolapse andor urinary incontinence surgery will decrease the incidence of symptomatic and culture proven urinary tract infection UTI when compared to placebo in a randomized double-blind trial
Secondary Aims To determine how nitrofurantoin antibiotic prophylaxis administered to patients using an indwelling catheter or CISC after pelvic organ prolapse andor urinary incontinence surgery affects frequency of adverse events related to daily nitrofurantoin exposure and frequency of urine cultures positive for nitrofurantoin-resistant isolates
The Null Hypotheses Nitrofurantoin antibiotic prophylaxis administered to patients using an indwelling catheter or CISC after pelvic organ prolapse andor urinary incontinence surgery does not change the incidence of symptomatic and culture proven urinary tract infection UTI compared with placebo
The substantial risk of UTI following POP or incontinence surgery combined with the well-established risk associated with catheterization leads many practitioners to prescribe oral antibiotics to women undergoing catheterization in the postoperative period However there is minimal Level I evidence to support or refute this practice The Infectious Disease Society of America IDSA Guideline acknowledges that prophylactic antibiotics have been shown to reduce UTI rates among patients using short term postoperative catheterization in randomized trials However they recommend against routine antibiotic prophylaxis use due to concerns regarding anti-microbial resistance cost and potential for adverse effects even among high risk groups including women undergoing urogynecologic surgery This recommendation is based on expert opinion given a paucity of trial data to guide clinical care
Nitrofurantoin is a commonly used antibiotic for UTI prophylaxis during catheterization is well-tolerated with few adverse effects and is known to have a very low rate of associated resistance After decades of use it remains active against the most common UTI pathogens that have gained resistance to other antimicrobials For example in the 2013 Magee-Womens Hospital Adult Antibiogram 98 of E-coli specimens were sensitive to Nitrofurantoin which has been consistent since at least 2007 The drug has a half-life of 20 minutes and 40 is concentrated in and excreted into the urine in a therapeutically unchanged form Thus it has minimal impact on vaginal and bowel flora Nitrofurantoin has been shown to reduce the incidence of positive urine cultures and symptomatic UTIs in women with a suprapubic catheter after pelvic organ prolapse andor urinary incontinence surgery No trials have evaluated nitrofurantoin prophylaxis for women using short term indwelling catheters or CISC following urogynecologic procedures
Given the large number of women at risk for urinary infectious morbidity associated with short term catheterization for acute urinary retention following POP andor incontinence surgery and the paucity of data on the impact of antibiotic prophylaxis in this setting we propose to demonstrate the efficacy of nitrofurantoin prophylaxis through an adequately-powered placebo-controlled trial Secondary outcomes will include adverse events associated with nitrofurantoin use and incidence of nitrofurantoin resistant bacterial isolates from urine culture
Primary Aim To determine if extended release nitrofurantoin administered daily to patients using indwelling or clean intermittent self-catheterization CISC after pelvic organ prolapse andor urinary incontinence surgery will decrease the incidence of symptomatic and culture proven urinary tract infection UTI when compared to placebo in a randomized double-blind trial
Secondary Aims To determine how nitrofurantoin antibiotic prophylaxis administered to patients using an indwelling catheter or CISC after pelvic organ prolapse andor urinary incontinence surgery affects frequency of adverse events related to daily nitrofurantoin exposure and frequency of urine cultures positive for nitrofurantoin-resistant isolates
The Null Hypotheses Nitrofurantoin antibiotic prophylaxis administered to patients using an indwelling catheter or CISC after pelvic organ prolapse andor urinary incontinence surgery does not change the incidence of symptomatic and culture proven urinary tract infection UTI compared with placebo
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