Conditions: Urinary Tract Infections
Keywords: urinary catheterization urinary tract infection urinary incontinence pelvic floor prolapse antibiotics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: yes

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.

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 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.

Arms:
arm 1: extended release nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC arm 2: identical appearing placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

Interventions: intervention 1: Nitrofurantoin intervention 2: Placebo
Intervention descriptions: intervention 1: nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC intervention 2: Placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

Protocol document: