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Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs

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ClinicalTrials.gov Identifier: NCT03077711
Recruitment Status : Active, not recruiting
First Posted : March 13, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Carolyn Botros, NorthShore University HealthSystem

Tracking Information
First Submitted Date  ICMJE February 27, 2017
First Posted Date  ICMJE March 13, 2017
Last Update Posted Date September 5, 2018
Actual Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
  • Time to subsequent infection as defined from time of treatment initiation to recurrence of UTI [ Time Frame: up to 12 months ]
    Patients will be advised to follow up with any symptoms of a recurrence or at 6 and 12 month intervals if symptom-free.
  • Infection free patients [ Time Frame: up to 12 months ]
    The number of patient infection free after 12 months as defined by no symptoms and negative urine cultures if symptomatic.
  • Number of infections [ Time Frame: up to 12 months ]
    The number of infections in both a 6 month and 12 month follow up time period as defined by symptoms and positive urine culture.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03077711 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
  • Adverse effects [ Time Frame: up to 12 months ]
    The percentage of patients complaining of adverse effects of each medication, including dyspepsia, dysuria, rash, pruritus, nausea, epigastric pain, vomiting, glossitis, taste changes, fever, and photosensitivity.
  • Estrogen effect [ Time Frame: up to 12 months ]
    The additive effect of estrogen cream to prevention (which is also a known protective agent to recurrent UTIs in postmenopausal women), which will be determined using logistic regression at the conclusion of the study.
  • Morisky Medication Adherence Survey [ Time Frame: up to 12 months ]
    Patient tolerability of medications using a tolerability survey.
  • Bacterial infection prevalence and types [ Time Frame: up to 12 months ]
    Urine cultures and sensitivities for positive urine cultures
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs
Official Title  ICMJE Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs
Brief Summary Several methods are available for use in the prevention of recurrent urinary tract infections (UTIs) over the past few decades. These methods include suppressive antibiotics, estrogen cream, methenamine hippurate, d-mannose, cranberry, probiotics, and vitamin C. Of these, the majority of the literature is in favor of use of suppressive antibiotics for preventing UTIs. However, this data is now about 10 years old. Increasing use of antibiotics over the years has lead to increased resistance of bacteria. In addition, long-term antibiotic use has several adverse effects, some life-threatening. There is recent literature evaluating the use of several of the alternatives to suppressive antibiotics with mixed results. A comparative study of the efficacy of methenamine hippurate to suppressive antibiotics is lacking in the current literature. Several early partly-randomized trials done with methenamine hippurate have shown promising results, but are only as recent as 1987. The primary objective of this prospective, randomized study is to determine whether there is a significant difference in the prevention of recurrent UTIs when given either methenamine hippurate or daily suppressive antibiotics. The secondary objective of this study is to determine how well patients are able to tolerate each of these medications and what adverse effects are observed in a given 1 year time period. The long-term goals of this study are to find an alternative to using suppressive antibiotics, potentially with a lower adverse effect profile and less of the dangers of long term antibiotic use. Finding an alternative to suppressive antibiotics would also tackle the issue of antibiotic resistance.
Detailed Description

Hypothesis:

The hypothesis of this study is that the group taking trimethoprim will have a lower recurrence rate than those taking methenamine hippurate based on the literature. The investigators aim to identify to what degree that difference is and whether or not it is an acceptable difference given the greater degree of an antibiotic resistance.

Objectives:

The primary objective of this prospective, randomized study is to determine whether there is a significant difference in the prevention of recurrent UTIs when given either methenamine hippurate or daily suppressive antibiotics independent of vaginal estrogen use.

The secondary objective of this study is to determine how well patients are able to tolerate each of these medications and what adverse effects are observed in a 1 year time period.

Specific Aims:

  1. Identify if there is a differential impact on prevention of recurrent UTIs when treated with either trimethoprim or methenamine hippurate in a 6 and 12 month period.
  2. Identify adverse reactions in each group.
  3. Determine whether or not estrogen has a more additive effect to trimethoprim or methenamine hippurate in post-menopausal women.
  4. Identify how well tolerated the study medications are and whether or not the size of the pills or the frequency of taking them prevents patients from continuing therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients diagnosed with recurrent urinary tract infections are recruited into this study.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Urinary Tract Infections, Recurrent
Intervention  ICMJE
  • Drug: Trimethoprim
    suppressive antibiotic. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study).
    Other Name: Trimpex
  • Drug: Methenamine hippurate
    antiseptic used in the prevention of recurrent UTIs. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study).
    Other Name: Hiprex
Study Arms  ICMJE
  • Active Comparator: Patients with recurrent UTIs arm 1
    Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.
    Intervention: Drug: Methenamine hippurate
  • Active Comparator: Patients with recurrent UTIs arm 2
    Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.
    Intervention: Drug: Trimethoprim
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 3, 2018)
106
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2017)
130
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • recurrent UTI: at least 2 in the past 6 months or 3 in past year (culture positive)
  • must have been symptomatic with dysuria, urgency, frequency, suprapubic pain, hematuria, malodorous urine
  • treated for last UTI and negative urine culture on entry into study
  • English speaking

Exclusion Criteria:

  • pregnancy
  • urinary tract abnormalities (eg kidney stones)
  • acute pyelonephritis
  • renal insufficiency or failure
  • known allergy to medications
  • prophylaxis for post-coital recurrent UTIs
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03077711
Other Study ID Numbers  ICMJE EH16-216
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The investigators are currently only recruiting at one institution and only researchers on the original institutional review board will have access to data. Only the principal investigator and research coordinator will have the data to be analyzed.
Responsible Party Carolyn Botros, NorthShore University HealthSystem
Study Sponsor  ICMJE NorthShore University HealthSystem
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NorthShore University HealthSystem
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP