Ignite Creation Date:
2024-05-05 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00678041
Status:
TERMINATED
Last Update Posted:
2016-09-27
First Post:
2008-05-10
Brief Title:
Nitrofurantoin and Urinary Tract Infections UTIs
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Trial Examining the Effect of Nitrofurantoin Prophylaxis in Women Performing Clean Intermittent Self-catheterization CISC After Surgery for Urinary Incontinence andor Pelvic Organ Prolapse
Status:
TERMINATED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate patient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APPIC
Brief Summary:
Urinary tract infection UTI is the most common complication after surgery for prolapse or urinary incontinence UTIs are painful and have the potential to turn into kidney infections We are asking women who self-catheterize after surgery to try either an antibiotic or a placebo pill so we can see if we can prevent UTIs without causing side effects
This study will not require any additional visits or blood draws You will be asked to answer some questions keep a brief diary of your experience and immediately report any symptoms of a UTI to your doctor
This study will not require any additional visits or blood draws You will be asked to answer some questions keep a brief diary of your experience and immediately report any symptoms of a UTI to your doctor
Detailed Description:
Abstract
Specific aim to determine if extended release nitrofurantoin antibiotic prophylaxis administered to patients performing clean intermittent self-catheterization CISC after pelvic organ prolapse andor urinary incontinence surgery decreases the incidence of symptomatic urinary tract infection UTI compared with placebo
Study Design Randomized double-blind placebo-controlled trial
Methods 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 and for three subsequent days after stopping CISC Catheterized urine specimens will be sent for culture and sensitivity when women report symptoms consistent with cystitis Symptomatic UTI will be defined using strict culture-based definitions We anticipate that the study will end within 6 weeks of starting CISC
Data Analysis Primary and secondary outcomes will be evaluated with Student t test and Fisher exact test
Sample Size Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 33 to 10 with 80 power and a two-sided alpha of 005 and a 10 dropout rate we should recruit a total of 108 patients
Specific aim to determine if extended release nitrofurantoin antibiotic prophylaxis administered to patients performing clean intermittent self-catheterization CISC after pelvic organ prolapse andor urinary incontinence surgery decreases the incidence of symptomatic urinary tract infection UTI compared with placebo
Study Design Randomized double-blind placebo-controlled trial
Methods 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 and for three subsequent days after stopping CISC Catheterized urine specimens will be sent for culture and sensitivity when women report symptoms consistent with cystitis Symptomatic UTI will be defined using strict culture-based definitions We anticipate that the study will end within 6 weeks of starting CISC
Data Analysis Primary and secondary outcomes will be evaluated with Student t test and Fisher exact test
Sample Size Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 33 to 10 with 80 power and a two-sided alpha of 005 and a 10 dropout rate we should recruit a total of 108 patients
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