Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs
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|ClinicalTrials.gov Identifier: NCT03077711|
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections, Recurrent||Drug: Trimethoprim Drug: Methenamine hippurate||Phase 4|
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.
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients diagnosed with recurrent urinary tract infections are recruited into this study.|
|Masking:||None (Open Label)|
|Official Title:||Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs|
|Actual Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2019|
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.
suppressive antibiotic. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study).
Other Name: Trimpex
- 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.
- Infection free patients [ Time Frame: up to 12 months ]The number of patient infection free after 12 months as defined by no symptoms and negative urine cultures if symptomatic.
- Number of infections [ Time Frame: up to 12 months ]The number of infections in both a 6 month and 12 month follow up time period as defined by symptoms and positive urine culture.
- 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.
- Estrogen effect [ Time Frame: up to 12 months ]The additive effect of estrogen cream to prevention (which is also a known protective agent to recurrent UTIs in postmenopausal women), which will be determined using logistic regression at the conclusion of the study.
- Morisky Medication Adherence Survey [ Time Frame: up to 12 months ]Patient tolerability of medications using a tolerability survey.
- Bacterial infection prevalence and types [ Time Frame: up to 12 months ]Urine cultures and sensitivities for positive urine cultures
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
|United States, Illinois|
|NorthShore Univeristy HealthSystem||Recruiting|
|Skokie, Illinois, United States, 60076|
|Contact: Carolyn Botros, DO 224-251-2374 email@example.com|