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Trial record 2 of 135 for:    daniel lee | Open Studies

Short-course Methenamine Hippurate for Prevention of Post-operative UTI (NO-UTI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02358993
First received: February 3, 2015
Last updated: October 5, 2016
Last verified: October 2016
  Purpose
The investigators will determine the efficacy of an innovative short regimen of methenamine hippurate on prevention of post-operative UTI in patients requiring short-term catheterization after pelvic reconstructive surgery through a single-blind, randomized controlled trial. Primary outcome will be the rate of symptomatic UTI within 3 weeks of catheter removal. The investigators will study cost-effectiveness, antibiotic resistance profiles, and adverse drug effects. Findings may reduce antibiotic use and nosocomial UTIs.

Condition Intervention
Urinary Tract Infections
Catheter-Related Infections
Drug: methenamine hippurate
Drug: Ciprofloxacin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Efficacy and Cost-effectiveness of a 24-hour Course of metheNamine Hippurate for Preventing Post-Operative Urinary Tract Infection

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Treatment of clinically suspected UTI [ Time Frame: 3 weeks post-operative ] [ Designated as safety issue: No ]
    This is defined as any symptomatic UTI requiring treatment with antibiotics as determined by the development of 2 or more of the following symptoms, in the absence of vaginal symptoms: urinary frequency; urinary urgency; dysuria; fever over 38oC/100.4oF; suprapubic, flank, or back pain; and/or chills.


Secondary Outcome Measures:
  • Rate of culture-positive symptomatic UTI [ Time Frame: 3 weeks post-operative ] [ Designated as safety issue: No ]
    All patients will be encouraged to submit urine cultures prior to treatment, but this is not always possible. Amongst patients who undergo urine culture as part of standard of care for UTI, the rate of positive cultures will be identified.

  • Antibiotic resistance of culture-positive symptomatic UTI [ Time Frame: 3 weeks post-operative ] [ Designated as safety issue: No ]
    All patients who submit urine cultures that are positive will have sensitivities performed as per standard care. The prevalence of bacterial species and sensitivities will be collected

  • Cost-effectiveness of prophylaxis with methenamine hippurate for prevention of post-operative UTI compared to prophylaxis with fluoroquinolones [ Time Frame: 3 weeks post-operative ] [ Designated as safety issue: No ]
    Routine costs of prevention of UTI with methenamine hippurate prophylaxis will be compared with costs of prevention of UTI with fluoroquinolone prophylaxis. We plan to capture costs for each direct medical service use, direct non-medical items, and indirect items related to post-operative UTIs in each arm of the trial.

  • Prevalence of side effects [ Time Frame: within 24 hours of administration ] [ Designated as safety issue: Yes ]
    Adverse effects from the administration of methenamine and fluoroquinolones will be collected.


Other Outcome Measures:
  • Rate of UTI consistent with NHSN criteria [ Time Frame: 3 weeks post-operative ] [ Designated as safety issue: No ]
    We plan to analyze the prevalence of UTI in this population that meet the definitions of symptomatic UTI and catheter-associated UTI according to the National Healthcare Safety Network criteria.


Estimated Enrollment: 240
Study Start Date: December 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methenamine
Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal.
Drug: methenamine hippurate
A urinary antiseptic used for prevention of UTI
Other Name: Hiprex
Active Comparator: Ciprofloxacin
Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal.
Drug: Ciprofloxacin
An antibiotic used for treatment and prevention of UTI
Other Name: Cipro

Detailed Description:

Prevention of post-operative urinary tract infections (UTI) is becoming important for both the individual patient and the health system. Complications of UTI include pyelonephritis and bacteremia, requiring hospitalization and parenteral antibiotics. Additionally, recurrent exposure to antibiotics commonly given for UTIs increases the risk of antibiotic resistance to uropathogens. UTIs also increase economic burdens on the health care system, with each episode costing nearly 600 dollars. UTIs associated with catheterization are particularly costly for hospitals, resulting in decreased hospital quality measures and lack of compensation.

This is particularly important after pelvic reconstructive surgery, as reported rates of UTI reach up to 20-25%. Urinary retention requiring short-term indwelling catheterization, common in these women, contributes to the risk of UTIs by increasing the risk of bacteriuria by 5-10% per day and through the dislodging of bacterial colonies during catheter removal. Balancing prevention and resistance and cost is key. A meta-analysis by Marschall et al indicated the benefit of a short dose of antibiotic prophylaxis at catheter removal in general post-surgical patients. However, data is lacking on the effects of daily antibiotic prophylaxis on resistance and cost.

A possible alternative to antibiotics presents itself in methenamine hippurate, a urinary antiseptic which forms formaldehyde in the presence of acidic urine. It is relatively inexpensive, and does not induce resistance in vivo. Prior studies have shown that daily use of methenamine can decrease the risk of post-operative UTI.

The purpose of our study was to investigate the efficacy of a short course of methenamine hippurate at catheter removal to that of a short course of ciprofloxacin in prevention of UTIs after short-term indwelling catheterization. Additionally, we investigated factors that influence post-operative UTIs, the rate of culture-proven UTIs after prophylaxis, the antibiotic resistance profile of those undergoing prophylaxis, and the cost effectiveness of prophylaxis.

  Eligibility

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

Inclusion Criteria:

  • female;
  • patients who are able to read and write English;
  • 18 years of age or older;
  • underwent surgery for pelvic organ prolapse, urinary incontinence, or both;
  • require post-operative short-term transurethral catheterization for greater than 24 hours.

Exclusion Criteria:

  • patients undergoing surgical intervention for sacral neuromodulation, or mesh excision;
  • patients requiring long-term catheterization secondary to injury to the urinary tract;
  • patients who pass their post-operative trial void and thus, do not require additional catheterization;
  • patients requiring catheterization for less than 24 hours;
  • pregnant patients;
  • patients who are breast-feeding;
  • allergy to methenamine hippurate or fluroquinolones (either ciprofloxacin or levofloxacin);
  • impaired renal or hepatic function;
  • pre-operative urinary retention;
  • patients who are currently using sulfonamides;
  • patients who have severe dehydration;
  • patients using tizanidine;
  • patients sensitive to quinolones class;
  • patients using theophylline; patients with myasthenia gravis;
  • patients with prolongation of QT interval.
  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: NCT02358993

Contacts
Contact: Daniel Lee, MD 215 662 4000 daniel.lee@uphs.upenn.edu
Contact: Lily Arya, MD, MS 215-662-4144 larya@obgyn.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Daniel Lee, MD    215-662-4000    daniel.lee@uphs.upenn.edu   
Contact: Lily Arya, MD, MS    215-615-7514    larya@obgyn.upenn.edu   
Sub-Investigator: Ariana L Smith, MD         
Principal Investigator: Christine M Chu, MD         
Penn Presbyterian Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Daniel Lee, MD    215-662-4000    daniel.lee@uphs.upenn.edu   
Contact: Uduak Andy, MD    215-662-6035    uduakumoh.andy@uphs.upenn.edu   
Principal Investigator: Christine M Chu, MD         
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Daniel Lee, MD    215-662-4000    daniel.lee@uphs.upenn.edu   
Contact: Heidi Harvie, MD, MSCE    215 829 2345    hharvie@obgyn.upenn.edu   
Sub-Investigator: Pamela Levin, MD         
Sub-Investigator: Ariana L Smith, MD         
Principal Investigator: Christine M Chu, MD         
Chestnut Hill Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19118
Contact: Daniel Lee, MD    215-662-4000    christine.chu@uphs.upenn.edu   
Contact: Heidi Harvie, MD, MSCE    215-829-2345    hharvie@obgyn.upenn.edu   
Principal Investigator: Christine M Chu, MD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Christine M Chu, MD University of Pennsylvania
Study Director: Lily Arya, MD, MS University of Pennsylvania
Principal Investigator: Daniel Lee, MD University of Pennsylvania
  More Information

Additional Information:
Publications:

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02358993     History of Changes
Other Study ID Numbers: 820117 
Study First Received: February 3, 2015
Last Updated: October 5, 2016
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Pennsylvania:
Urinary Tract Infections
Catheter-Related Infections
Pelvic Reconstructive Surgery
Urogynecology
Urinary catheterization
Post-operative Infections
Methenamine hippurate

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Catheter-Related Infections
Urologic Diseases
Methenamine hippurate
Methenamine
Ciprofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on December 09, 2016