Nitrofurantoin and Urinary Tract Infections (UTIs) - Full Text View

Sponsor:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00678041

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

MedlinePlus related topics: Antibiotics Pelvic Support Problems Surgery Urinary Incontinence Urinary Tract Infections Urine and Urination

Drug Information available for: Nitrofurantoin Nitrofurantoin monohydrate

U.S. FDA Resources

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
1: Experimental 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
2: Placebo Comparator 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

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:	University of Pittsburgh ( Gary Sutkin, MD )
Study ID Numbers:	SutkinAppic
Study First Received:	May 10, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00678041 History of Changes
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:

Communicable Diseases
Anti-Infective Agents
Urination Disorders
Urinary Tract Infections
Anti-Infective Agents, Urinary
Renal Agents
Infection

Pharmacologic Actions
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Nitrofurantoin
Therapeutic Uses
Urinary Incontinence

ClinicalTrials.gov processed this record on November 20, 2009