Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs

Urinary Tract Infections, Recurrent Clinical Trial

Official title:

Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077711
• Other study ID #: EH16-216
• Status: Completed
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: June 21, 2019

Study information

• Verified date: January 2020
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Urinary Tract Infections
• Urinary Tract Infections, Recurrent

Intervention

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

Locations

Country	Name	City	State
United States	NorthShore Univeristy HealthSystem	Skokie	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Recurrent UTI	The number of patient who had a recurrence of UTI within 12 months	up to 12 months
Primary	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	Adverse Effects	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.	up to 12 months
Secondary	Morisky Medication Adherence Survey	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.	up to 12 months
Secondary	Bacterial Infection Prevalence and Types	Urine cultures and sensitivities for positive urine cultures	up to 12 months