Nitrofurantoin and Urinary Tract Infections (UTIs) (APPIC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00678041
First received: May 10, 2008
Last updated: December 19, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention
Urinary Tract Infections
Drug: Nitrofurantoin
Drug: Placebo

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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • time (days after surgery) to development of symptomatic, culture documented UTI [ Time Frame: 6 weeks after surgery ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
  • adherence to CISC [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: Yes ]
  • patient perceptions regarding CISC [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: Yes ]
  • frequency of adverse events related to CISC such as urethral pain, irritative voiding symptoms, hematuria [ Time Frame: 6 weeks after surgery ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 108
Study Start Date: May 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC
Drug: Nitrofurantoin
nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC
Other Name: Macrodantin
Placebo Comparator: 2
identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC
Drug: Placebo
Placebo

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678041

Contacts
Contact: Gary Sutkin, MD 412-641-1440 gsutkin@magee.edu
Contact: Judy Gruss, RN 412-641-1440 jgruss@magee.edu

Locations
United States, Pennsylvania
Magee Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Gary Sutkin, MD    412-641-1440    gsutkin@magee.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Gary Sutkin, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Gary Sutkin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00678041     History of Changes
Other Study ID Numbers: SutkinAppic
Study First Received: May 10, 2008
Last Updated: December 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
urinary catheterization
urinary tract infection
urinary incontinence
pelvic floor prolapse
antibiotics

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Tract Infections
Pelvic Organ Prolapse
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Infection
Prolapse
Pathological Conditions, Anatomical
Nitrofurantoin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents

ClinicalTrials.gov processed this record on July 23, 2014