Mode
Text Size
Log in / Sign up
Phase 4 N=92 Randomized Prevention

Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs

Urinary Tract Infections, Recurrent

Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Time to Subsequent Infection as Defined From Time of Treatment Initiation to Recurrence of UTI — 101; 119 days

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Trimethoprim (Drug); Methenamine hippurate (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Endeavor Health
Primary completion
Jun 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to Subsequent Infection as Defined From Time of Treatment Initiation to Recurrence of UTI
101; 119
PRIMARY
Recurrent UTI
28; 28
PRIMARY
Number of Infections
1.5; 1.6
SECONDARY
Adverse Effects
1; 2; 2; 0; 1; 0
SECONDARY
Morisky Medication Adherence Survey
7.28; 6.94
SECONDARY
Bacterial Infection Prevalence and Types
43; 50; 11; 6; 3; 9

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03077711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search