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Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs

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ClinicalTrials.gov Identifier: NCT03077711
Recruitment Status : Completed
First Posted : March 13, 2017
Results First Posted : January 14, 2020
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Carolyn Botros, NorthShore University HealthSystem

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections, Recurrent Drug: Trimethoprim Drug: Methenamine hippurate Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
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
Official Title: Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs
Actual Study Start Date : June 2016
Actual Primary Completion Date : June 21, 2019
Actual Study Completion Date : June 21, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Recurrent UTI [ Time Frame: up to 12 months ]
    The number of patient who had a recurrence of UTI within 12 months

  3. Number of Infections [ Time Frame: up to 12 months ]
    The number of infections at a 12 month follow up time period as defined by symptoms and positive urine culture.


Secondary Outcome Measures :
  1. 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.

  2. Morisky Medication Adherence Survey [ Time Frame: up to 12 months ]
    Morisky Medication Adherence Scale-8 (MMAS-8). Patient tolerability of medications using a tolerability survey. Minimum and maximum scores are 0 and 8 respectively. 0 means no adherence and 8 is maximal adherence. Low adherence corresponds to a score less than 6, medium adherence is between 6 and <8, and 8 is high adherence.

  3. Bacterial Infection Prevalence and Types [ Time Frame: up to 12 months ]
    Urine cultures and sensitivities for positive urine cultures


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT03077711


Locations
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United States, Illinois
NorthShore Univeristy HealthSystem
Skokie, Illinois, United States, 60076
Sponsors and Collaborators
NorthShore University HealthSystem
  Study Documents (Full-Text)

Documents provided by Carolyn Botros, NorthShore University HealthSystem:
Study Protocol and Statistical Analysis Plan  [PDF] February 8, 2016

More Information
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Responsible Party: Carolyn Botros, Female Pelvic Medicine and Reconstructive Surgery, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT03077711    
Other Study ID Numbers: EH16-216
First Posted: March 13, 2017    Key Record Dates
Results First Posted: January 14, 2020
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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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
Additional relevant MeSH terms:
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Urinary Tract Infections
Reinfection
Infections
Urologic Diseases
Recurrence
Disease Attributes
Pathologic Processes
Trimethoprim
Methenamine
Methenamine hippurate
Methenamine mandelate
Anti-Infective Agents, Urinary
 Anti-Infective Agents
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Bacterial Agents