Nitrofurantoin and Urinary Tract Infections (UTIs)

Not Applicable

Terminated

Conditions: Urinary Tract Infections

Interventions: Drug: Nitrofurantoin
Drug: Placebo

Registration Number: NCT00678041

Lead Sponsor: University of Pittsburgh

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 10

Inclusion Criteria

Women who fail a post-operative voiding trial and are willing to learn clean intermittent self-catheterization (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 Urinary Tract Infections (UTIs) per year
Known immunocompromised condition (organ transplant, chemotherapy for cancer or arthritis, autoimmune diseases (lupus etc)).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Nitrofurantoin Group	Nitrofurantoin	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: Placebo Group	Placebo	identical appearing placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

Primary Outcome Measures

Name	Time	Method
Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation	6 to 8 weeks after surgery	Participants are to be assessed for UTI systems and f/u urine culture routine over a period of 6 to 8 weeks after CISC teaching and implementation.

Secondary Outcome Measures

Name	Time	Method
Frequency of Adverse Events Related to Daily Nitrofurantoin Exposure Such as Nausea, Diarrhea, C. Difficile Colitis	6 weeks after surgery	0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Time (Days After Surgery) to Development of Symptomatic, Culture Documented UTI	6 weeks after surgery	0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Frequency of Adverse Events Related to CISC Such as Urethral Pain, Irritative Voiding Symptoms, Hematuria	6 weeks after surgery	0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Frequency of Urine Cultures Positive for Organism Strains That Are Resistant to Nitrofurantoin and Other Commonly Used Antibiotics.	6 weeks after surgery	0 participants analyzed due to study termination.Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Adherence to CISC	6 weeks after surgery	0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Patient Perceptions Regarding CISC	6 weeks after surgery	0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.