Nitrofurantoin and Urinary Tract Infections (UTIs)

Condition(s) targeted: Urinary Tract Infections

Intervention: Nitrofurantoin (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Gary Sutkin, MD, Principal Investigator, Affiliation: University of Pittsburgh

Overall contact:
Gary Sutkin, MD, Phone: 412-641-1440, Email: gsutkin@magee.edu

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: primary outcome: the frequency of symptomatic UTI's confirmed with a positive urine culture within 6 to 8 weeks after CISC teaching and implementation

Secondary outcome:

time (days after surgery) to development of symptomatic, culture documented UTI

frequency of urine cultures positive for organism strains that are resistant to nitrofurantoin and other commonly used antibiotics.

adherence to CISC

patient perceptions regarding CISC

frequency of adverse events related to CISC such as urethral pain, irritative voiding symptoms, hematuria

frequency of adverse events related to daily nitrofurantoin exposure such as nausea, diarrhea, C. difficile colitis

Detailed description: 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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

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)).

Gary Sutkin, MD, Phone: 412-641-1440, Email: gsutkin@magee.edu

Magee Womens Hospital, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Gary Sutkin, MD, Phone: 412-641-1440, Email: gsutkin@magee.edu

Starting date: May 2008
Last updated: December 19, 2008