Urinary Tract Infections, RecurrentPhase 4NCT03077711
Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs
A Phase 4 study testing Trimethoprim and Methenamine hippurate in people with Urinary Tract Infections, Recurrent, run by Endeavor Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections, Recurrent
- What is being tested?
- Trimethoprim and Methenamine hippurate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 21 Jun 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- urinary tract abnormalities (eg kidney stones)
- acute pyelonephritis
- renal insufficiency or failure
- known allergy to medications
- prophylaxis for post-coital recurrent UTIs
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore Univeristy HealthSystem
Skokie, Illinois, 60076
About this study
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.
Read the detailed 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:
- 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.
- Conditions
- Urinary Tract Infections, Recurrent
- Being tested
- Trimethoprim, Methenamine hippurate
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimethoprimDrug
Also called Trimpex
suppressive antibiotic. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study).
Methenamine hippurateDrug
Also called Hiprex
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Trimethoprim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Recurrent UTI
The number of patient who had a recurrence of UTI within 12 months
Measured: 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.
Measured: up to 12 months
Secondary outcomes (3)
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.
Measured: up to 12 months
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.
Measured: up to 12 months
Bacterial Infection Prevalence and Types
Urine cultures and sensitivities for positive urine cultures
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study startJun 2016
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Tract Infections, RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients diagnosed with recurrent urinary tract infections are recruited into this study.
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Botros, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077711
- Sponsor's protocol ID
- EH16-216
- Status last verified
- Jan 2020
- First submitted
- 27 Feb 2017
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators are currently only recruiting at one institution and only researchers on the original institutional review board will have access to data. Only the principal investigator and research coordinator will have the data to be analyzed.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs
- ClinicalTrials.gov ID
- NCT03077711
- Acronym / sponsor ID
- EH16-216
- Conditions
- Urinary Tract Infections, Recurrent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Posted 14 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients diagnosed with recurrent urinary tract infections are recruited into this study.
| Arm | Type | Receives |
|---|---|---|
| Patients with recurrent UTIs arm 1 | Active comparator | Drug: Methenamine hippuratePatients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections. |
| Patients with recurrent UTIs arm 2 | Active comparator | Drug: TrimethoprimPatients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- pregnancy
- urinary tract abnormalities (eg kidney stones)
- acute pyelonephritis
- renal insufficiency or failure
- known allergy to medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrimethoprimAlso: Trimpexsuppressive antibiotic. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study). | Drug | Patients with recurrent UTIs arm 2 |
| Methenamine hippurateAlso: Hiprexantiseptic 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). | Drug | Patients with recurrent UTIs arm 1 |
Primary outcome
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.
Recurrent UTI
Time frame: up to 12 months
The number of patient who had a recurrence of UTI within 12 months
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.
3 secondary outcomes
Adverse Effects
Time frame: up to 12 months
Morisky Medication Adherence Survey
Time frame: up to 12 months
Bacterial Infection Prevalence and Types
Time frame: up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The investigators are currently only recruiting at one institution and only researchers on the original institutional review board will have access to data. Only the principal investigator and research coordinator will have the data to be analyzed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trimethoprim and Methenamine hippurate in people with Urinary Tract Infections, Recurrent, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Subsequent Infection as Defined From Time of Treatment Initiation to Recurrence of UTI (time frame: up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.