Nitrofurantoin and Urinary Tract Infections (UTIs)

Urinary Tract Infections Clinical Trial

— APPIC  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00678041
• Other study ID #: SutkinAppic
• Status: Terminated
• Phase: N/A
• First received: May 10, 2008
• Last updated: April 22, 2016
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: April 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)).

Study Design

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

Related Conditions & MeSH terms

• Infection
• Urinary Incontinence
• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
United States	Magee Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary outcome: the frequency of symptomatic UTI's confirmed with a positive urine culture within 6 to 8 weeks after CISC teaching and implementation		6 weeks after surgery	Yes
Secondary	time (days after surgery) to development of symptomatic, culture documented UTI		6 weeks after surgery	Yes
Secondary	frequency of urine cultures positive for organism strains that are resistant to nitrofurantoin and other commonly used antibiotics.		6 weeks after surgery	Yes
Secondary	adherence to CISC		6 weeks after surgery	Yes
Secondary	patient perceptions regarding CISC		6 weeks after surgery	Yes
Secondary	frequency of adverse events related to CISC such as urethral pain, irritative voiding symptoms, hematuria		6 weeks after surgery	Yes
Secondary	frequency of adverse events related to daily nitrofurantoin exposure such as nausea, diarrhea, C. difficile colitis		6 weeks after surgery	Yes