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Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery (NAUTICA)

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ClinicalTrials.gov Identifier: NCT03287089
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Dina A. Bastawros, MD, Carolinas Healthcare System

Brief Summary:

The specific aim of this randomized double-blind placebo-controlled trial is to evaluate the efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for the prevention of catheter-associated urinary tract infections in patients with postoperative short-term catheterization following pelvic reconstructive surgery and/or urinary incontinence surgery.

Patients that undergo pelvic organ prolapse and/or urinary incontinence surgery and fail their post-operative voiding trial will be included in the study. Upon successfully passing and in-office voiding trial at the time of catheter removal, they will be randomized to either nitrofurantoin 100mg twice daily or an identical appearing placebo capsule twice daily for 5 days following catheter removal. The primary outcome will be the treatment of clinically suspected and/or culture-proven UTI within 30 days of surgery. Secondary outcomes include adverse events associated with nitrofurantoin use and medication compliance.

Primary and secondary outcomes will be evaluated with Student t test and chi squared or Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 32% to 14%, with 80% power, and a two-sided alpha of 0.05, and a 10% dropout rate, we should recruit a total of 180 patients.


Condition or disease Intervention/treatment Phase
Catheter-Associated Urinary Tract Infection Drug: Nitrofurantoin 100 MG Drug: Placebo Oral Tablet Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery (NAUTICA): A Randomized Controlled Trial
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nitrofurantoin
Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal
Drug: Nitrofurantoin 100 MG
Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days

Placebo Comparator: Placebo
Receives twice daily matching placebo for 5 days following catheter removal
Drug: Placebo Oral Tablet
Matching placebo




Primary Outcome Measures :
  1. UTI [ Time Frame: 30 days ]
    Treatment of symptomatic urinary tract infection and rate of urinary tract infection in the first 30 days following pelvic reconstructive surgery


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 5 days ]
    Any adverse event only related to drug administration

  2. Medication compliance [ Time Frame: 5 days ]
    Assessed by use of a medication diary during treatment period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than 18
  • Creatinine clearance greater than 30 ml/min
  • Failed postoperative hospital voiding trial

Exclusion Criteria:

  • Pregnant
  • History of glucose-6-phosphate dehydrogenase deficiency
  • History of renal insufficiency, renal transplant, or nephropathy
  • Allergy to nitrofurantoin
  • History of recurrent UTI (defined as greater than two culture-proven infections in six months or three infections in one year)
  • Urinary Tract Infection (UTI) within 14 days one month of surgery
  • Non-English speaking
  • Urinary tract infection while Foley catheter is in place
  • On antibiotic therapy for other non-urological reasons
  • Sustained intraoperative bladder injury requiring prolonged catheterization greater than 5 days
  • Undergoing mesh excision from within the bladder, fistula repair, cystotomy repair, urethral diverticulectomy, sacral neuromodulation, urethral surgery, or any other procedure requiring prolonged catheterization and bladder decompression
  • Placement of a suprapubic catheter
  • Participants that request intermittent self-catheterization
  • Neurologic conditions affecting urinary tract system and normal voiding mechanisms
  • History of hepatic impairment due to prior nitrofurantoin use
  • Inability to provide consent/decisionally impaired
  • More than two in-office voiding trials

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287089


Contacts
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Contact: Dina Bastawros, MD 704-304-1160 Dina.Bastawros@carolinashealthcare.org
Contact: Kelley Kaczmarski, RN, BSN 704-355-4891 Kelley.Kaczmarski@carolinashealthcare.org

Locations
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United States, North Carolina
Carolinas Health Care System Recruiting
Charlotte, North Carolina, United States, 28206
Contact: Dina Bastawros, MD    704-304-1160    dina.bastawros@carolinashealthcare.org   
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
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Principal Investigator: Dina Bastawros, MD Carolinas Health Care System

Publications:
Wolf SJ, Bennett CJ, Dmochowski RR et al. (2012). Urologic Surgery Antimicrobial Prophylaxis. American Urological Association. Retrieved from http://www.auanet.org/guidelines/antimicrobial-prophylaxis-(2008-reviewed-and-validity-confirmed-2011-amended-2012)

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Responsible Party: Dina A. Bastawros, MD, FPMRS Fellow/Junior Faculty, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT03287089     History of Changes
Other Study ID Numbers: Pro00022622
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dina A. Bastawros, MD, Carolinas Healthcare System:
Nitrofurantoin
Prolapse
Pelvic Organ Prolapse
Anti-incontinence procedure
Urinary retention
Urinary Tract Infection
Short-term catheterization

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Nitrofurantoin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents