Nitrofurantoin and Urinary Tract Infections (UTIs)

NCT ID: NCT00678041

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-05-31

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.

Conditions

Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 1: Nitrofurantoin Group

extended release nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

Group Type: EXPERIMENTAL

Nitrofurantoin

Intervention Type: DRUG

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

identical appearing placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

Interventions

Nitrofurantoin

nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

Intervention Type: DRUG

Placebo

Placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

Intervention Type: DRUG

Other Intervention Names

Macrodantin

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)).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Gary Sutkin

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary Sutkin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

SutkinAppic

Identifier Type: -

Identifier Source: org_study_id