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

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT02358993
Collaborator
(none)
201
Enrollment
4
Locations
2
Arms
70
Actual Duration (Months)
50.3
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
201 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
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
Actual Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Sep 30, 2020
Actual Study Completion Date :
Sep 30, 2020

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Cipro

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Treatment of Clinically Suspected UTI - Using Intent to Treat Analysis [3 weeks post-operative]

      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.

    2. Treatment of Clinically Suspected UTI - Per Protocol [3 weeks post-operative]

      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

    1. Number of Participants With Culture-positive Symptomatic UTI [3 weeks post-operative]

      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.

    2. Antibiotic Resistance of Culture-positive Symptomatic UTI [3 weeks post-operative]

      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

    3. Cost-effectiveness of Prophylaxis With Methenamine Hippurate for Prevention of Post-operative UTI Compared to Prophylaxis With Fluoroquinolones [3 weeks post-operative]

      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.

    4. Prevalence of Side Effects [within 24 hours of administration]

      Adverse effects from the administration of methenamine and fluoroquinolones will be collected.

    Other Outcome Measures

    1. Rate of UTI Consistent With NHSN Criteria [3 weeks post-operative]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    2 Penn Presbyterian Medical Center Philadelphia Pennsylvania United States 19104
    3 Pennsylvania Hospital Philadelphia Pennsylvania United States 19107
    4 Chestnut Hill Hospital Philadelphia Pennsylvania United States 19118

    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

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT02358993
    Other Study ID Numbers:
    • 820117
    First Posted:
    Feb 9, 2015
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    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:
    Infections
    Communicable Diseases
    Urinary Tract Infections
    Catheter-Related Infections
    Ciprofloxacin
    Methenamine hippurate
    Methenamine mandelate
    Methenamine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Methenamine Ciprofloxacin
    Arm/Group Description 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. methenamine hippurate: A urinary antiseptic used for prevention of UTI 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. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
    Period Title: Overall Study
    STARTED 105 96
    COMPLETED 103 94
    NOT COMPLETED 2 2

    Baseline Characteristics

    Arm/Group Title Methenamine Ciprofloxacin Total
    Arm/Group Description 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. methenamine hippurate: A urinary antiseptic used for prevention of UTI 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. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI Total of all reporting groups
    Overall Participants 103 94 197
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    63.9
    (10.7)
    61.6
    (10.5)
    62.8
    (10.6)
    Sex: Female, Male (Count of Participants)
    Female
    103
    100%
    94
    100%
    197
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    Caucasion
    83
    80.6%
    72
    76.6%
    155
    78.7%
    Black
    15
    14.6%
    18
    19.1%
    33
    16.8%
    Asian American/Pacific Islander
    2
    1.9%
    1
    1.1%
    3
    1.5%
    Did not answer
    1
    1%
    2
    2.1%
    3
    1.5%
    BMI (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    27.1
    (4.9)
    28
    (5.3)
    27.6
    (5.1)
    Postmenopausal (Count of Participants)
    Count of Participants [Participants]
    83
    80.6%
    71
    75.5%
    154
    78.2%
    Current Smoker (Count of Participants)
    Count of Participants [Participants]
    3
    2.9%
    5
    5.3%
    8
    4.1%
    History of recurrent UTI (Count of Participants)
    Count of Participants [Participants]
    4
    3.9%
    4
    4.3%
    8
    4.1%
    Recent preoperative UTI (Count of Participants)
    Count of Participants [Participants]
    4
    3.9%
    2
    2.1%
    6
    3%

    Outcome Measures

    1. Primary Outcome
    Title Treatment of Clinically Suspected UTI - Using Intent to Treat Analysis
    Description 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.
    Time Frame 3 weeks post-operative

    Outcome Measure Data

    Analysis Population Description
    Intent to Treat model
    Arm/Group Title Methenamine Ciprofloxacin
    Arm/Group Description 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. methenamine hippurate: A urinary antiseptic used for prevention of UTI 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. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
    Measure Participants 101 93
    Count of Participants [Participants]
    13
    12.6%
    12
    12.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Methenamine, Ciprofloxacin
    Comments
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority of the primary outcome was achieved if the lower limit of the 95% confidence interval of the mean difference was greater than the specified non-inferiority margin of 15%(a clinically relevant margin within the range of those commonly used in non-inferiority and equivalence trials for studies examining antibiotic use for UTI)
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value -.01
    Confidence Interval (2-Sided) 95%
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title Treatment of Clinically Suspected UTI - Per Protocol
    Description 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.
    Time Frame 3 weeks post-operative

    Outcome Measure Data

    Analysis Population Description
    Per protocol model
    Arm/Group Title Methenamine Ciprofloxacin
    Arm/Group Description 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. methenamine hippurate: A urinary antiseptic used for prevention of UTI 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. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
    Measure Participants 98 89
    Count of Participants [Participants]
    12
    11.7%
    12
    12.8%
    3. Secondary Outcome
    Title Number of Participants With Culture-positive Symptomatic UTI
    Description 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.
    Time Frame 3 weeks post-operative

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Methenamine Ciprofloxacin
    Arm/Group Description 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. methenamine hippurate: A urinary antiseptic used for prevention of UTI 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. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
    Measure Participants 101 93
    Count of Participants [Participants]
    5
    4.9%
    4
    4.3%
    4. Secondary Outcome
    Title Antibiotic Resistance of Culture-positive Symptomatic UTI
    Description 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
    Time Frame 3 weeks post-operative

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Methenamine Ciprofloxacin
    Arm/Group Description 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. methenamine hippurate: A urinary antiseptic used for prevention of UTI 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. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
    Measure Participants 101 93
    Count of Participants [Participants]
    0
    0%
    0
    0%
    5. Secondary Outcome
    Title Cost-effectiveness of Prophylaxis With Methenamine Hippurate for Prevention of Post-operative UTI Compared to Prophylaxis With Fluoroquinolones
    Description 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.
    Time Frame 3 weeks post-operative

    Outcome Measure Data

    Analysis Population Description
    The data for this secondary was not collected. No costs were captured.
    Arm/Group Title Methenamine Ciprofloxacin
    Arm/Group Description 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. methenamine hippurate: A urinary antiseptic used for prevention of UTI 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. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
    Measure Participants 0 0
    6. Secondary Outcome
    Title Prevalence of Side Effects
    Description Adverse effects from the administration of methenamine and fluoroquinolones will be collected.
    Time Frame within 24 hours of administration

    Outcome Measure Data

    Analysis Population Description
    The data for this secondary outcome measure was not collected.
    Arm/Group Title Methenamine Ciprofloxacin
    Arm/Group Description 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. methenamine hippurate: A urinary antiseptic used for prevention of UTI 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. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
    Measure Participants 0 0
    7. Other Pre-specified Outcome
    Title Rate of UTI Consistent With NHSN Criteria
    Description 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.
    Time Frame 3 weeks post-operative

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Methenamine Ciprofloxacin
    Arm/Group Description 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. methenamine hippurate: A urinary antiseptic used for prevention of UTI 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. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
    Measure Participants 101 93
    Count of Participants [Participants]
    10
    9.7%
    6
    6.4%

    Adverse Events

    Time Frame The AEs were collected from time of surgery to their clinical post-operative visit, usually between 4 and 12 weeks post-op.
    Adverse Event Reporting Description
    Arm/Group Title Methenamine Ciprofloxacin
    Arm/Group Description 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. methenamine hippurate: A urinary antiseptic used for prevention of UTI 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. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
    All Cause Mortality
    Methenamine Ciprofloxacin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/103 (0%) 0/94 (0%)
    Serious Adverse Events
    Methenamine Ciprofloxacin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/103 (0%) 0/94 (0%)
    Other (Not Including Serious) Adverse Events
    Methenamine Ciprofloxacin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/103 (0%) 3/94 (3.2%)
    Gastrointestinal disorders
    nausea 0/103 (0%) 0 2/94 (2.1%) 2
    Musculoskeletal and connective tissue disorders
    muscle pain 0/103 (0%) 0 1/94 (1.1%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr Uduak Andy
    Organization University of Pennsylvania
    Phone 215-662-7709
    Email uduak.andy@pennmedicine.upenn.edu
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT02358993
    Other Study ID Numbers:
    • 820117
    First Posted:
    Feb 9, 2015
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022