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NCT Number: NCT03077711

Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs

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.

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Key information

Conditions

Urinary Tract Infections, Recurrent Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

NorthShore Univeristy HealthSystem

Skokie, Illinois, 60076, United States

About this study

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:

  • 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.
  • Identify adverse reactions in each group.
  • Determine whether or not estrogen has a more additive effect to trimethoprim or methenamine hippurate in post-menopausal women.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trimethoprim

Drug

suppressive antibiotic. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study).

Other names: Trimpex

Methenamine Hippurate

Drug

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 names: Hiprex

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 13, 2017
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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