Clinical trial NCT00678041: Nitrofurantoin and Urinary Tract Infections (UTIs)
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 and/or Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Tract Infections
Keywords: urinary catheterization
urinary tract infection
urinary incontinence
pelvic floor prolapse
antibiotics
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)).

Primary outcomes:
measure: Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation
timeFrame: 6 to 8 weeks after surgery
Secondary outcomes:
measure: Time (Days After Surgery) to Development of Symptomatic, Culture Documented UTI
timeFrame: 6 weeks after surgery
measure: Frequency of Urine Cultures Positive for Organism Strains That Are Resistant to Nitrofurantoin and Other Commonly Used Antibiotics.
timeFrame: 6 weeks after surgery
measure: Adherence to CISC
timeFrame: 6 weeks after surgery
measure: Patient Perceptions Regarding CISC
timeFrame: 6 weeks after surgery
measure: Frequency of Adverse Events Related to CISC Such as Urethral Pain, Irritative Voiding Symptoms, Hematuria
timeFrame: 6 weeks after surgery
measure: Frequency of Adverse Events Related to Daily Nitrofurantoin Exposure Such as Nausea, Diarrhea, C. Difficile Colitis
timeFrame: 6 weeks after surgery
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Gary Sutkin, MD
role: PRINCIPAL_INVESTIGATOR
References: