Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs

NCT03077711 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: EH16-216
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections, Recurrent

Outcome Measures

Primary Outcomes (3)

• Time to Subsequent Infection as Defined From Time of Treatment Initiation to Recurrence of UTI

  Patients will be advised to follow up with any symptoms of a recurrence or at 6 and 12 month intervals if symptom-free.

  up to 12 months

• Recurrent UTI

  The number of patient who had a recurrence of UTI within 12 months

  up to 12 months

• Number of Infections

  The number of infections at a 12 month follow up time period as defined by symptoms and positive urine culture.

  up to 12 months

Secondary Outcomes (3)

• Adverse Effects

  up to 12 months

• Morisky Medication Adherence Survey

  up to 12 months

• Bacterial Infection Prevalence and Types

  up to 12 months

Study Arms (2)

Patients with recurrent UTIs arm 1

ACTIVE COMPARATOR

Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.

Drug: Methenamine hippurate

Patients with recurrent UTIs arm 2

ACTIVE COMPARATOR

Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.

Drug: Trimethoprim

Interventions

Trimethoprim DRUG

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

Also known as: Trimpex

Patients with recurrent UTIs arm 2

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).

Also known as: Hiprex

Patients with recurrent UTIs arm 1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnancy
• urinary tract abnormalities (eg kidney stones)
• acute pyelonephritis
• renal insufficiency or failure
• known allergy to medications
• prophylaxis for post-coital recurrent UTIs

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore Univeristy HealthSystem

Skokie, Illinois, 60076, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Trimethoprim; methenamine hippurate

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Carolyn Botros, DO
• Organization: Lehigh Valley Health Network

carolyn.botros@lvhn.org

4845917480

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Female Pelvic Medicine and Reconstructive Surgery

Model Details: Patients diagnosed with recurrent urinary tract infections are recruited into this study.

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 13, 2017
• Study Start: June 1, 2016
• Primary Completion: June 21, 2019
• Study Completion: June 21, 2019
• Last Updated: January 14, 2020
• Results First Posted: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)