Nitrofurantoin and Urinary Tract Infections (UTIs)
| Status: | Terminated |
|---|---|
| Conditions: | Other Indications, Infectious Disease, Urology, Urinary Tract Infections |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2008 |
| End Date: | May 2009 |
A Randomized, Double-blind, Placebo-controlled Trial Examining the Effect of Nitrofurantoin Prophylaxis in Women Performing Clean Intermittent Self-catheterization After Surgery for Urinary Incontinence and/or Pelvic Organ Prolapse
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.
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.
Abstract:
Specific aim: to determine if extended release nitrofurantoin antibiotic prophylaxis
administered to patients performing CISC after pelvic organ prolapse and/or 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 0.05, 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 CISC after pelvic organ prolapse and/or 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 0.05, and a 10%
dropout rate, we should recruit a total of 108 patients.
Inclusion Criteria:
- Women who fail a post-operative voiding trial and are willing to learn CISC prior to
discharge from the hospital
Exclusion Criteria:
- Known drug allergy to nitrofurantoin
- A history of renal insufficiency
- Renal transplant
- Renal nephropathy
- A recent history of more than 3 UTIs per year
- Known immunocompromised condition (organ transplant, chemotherapy for cancer or
arthritis, autoimmune diseases (lupus etc)).
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