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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Nitrofurantoin
  • nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC
• Placebo Comparator: 2
  • identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC

Primary Measures

• primary outcome: the frequency of symptomatic UTI's confirmed with a positive urine culture within 6 to 8 weeks after CISC teaching and implementation
  • Time Frame: 6 weeks after surgery
    Safety Issue?: Yes

Secondary Measures

• time (days after surgery) to development of symptomatic, culture documented UTI
  • Time Frame: 6 weeks after surgery
    Safety Issue?: Yes
• frequency of urine cultures positive for organism strains that are resistant to nitrofurantoin and other commonly used antibiotics.
  • Time Frame: 6 weeks after surgery
    Safety Issue?: Yes
• adherence to CISC
  • Time Frame: 6 weeks after surgery
    Safety Issue?: Yes
• patient perceptions regarding CISC
  • Time Frame: 6 weeks after surgery
    Safety Issue?: Yes
• frequency of adverse events related to CISC such as urethral pain, irritative voiding symptoms, hematuria
  • Time Frame: 6 weeks after surgery
    Safety Issue?: Yes
• frequency of adverse events related to daily nitrofurantoin exposure such as nausea, diarrhea, C. difficile colitis
  • Time Frame: 6 weeks after surgery
    Safety Issue?: Yes

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)).

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

Gary Sutkin, MD Principal Investigator University of Pittsburgh  

Overall Contact: Gary Sutkin, MD 412-641-1440 gsutkin@magee.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00678041

Study ID Number: SutkinAppic

ClinicalTrials.gov Identifier: NCT00678041

Health Authority: United States: Institutional Review Board