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NCT03077711 · ClinicalTrials.gov registry record · Phase 4
Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs
A Phase 4 study, sponsored by Endeavor Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 92
- Enrollment target
NCT03077711: Completed Phase 4 study, sponsored by Endeavor Health.
NCT03077711 is a Phase 4 study that has completed, run by Endeavor Health. The registered enrollment target is 92 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03077711, a Phase 4 study, has completed, sponsored by Endeavor Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 92 participants
- Enrollment target
Study 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.
Primary Outcome
Patients will be advised to follow up with any symptoms of a recurrence or at 6 and 12 month intervals if symptom-free.
Interventions
- DRUG Trimethoprim
- DRUG Methenamine hippurate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2016-06 |
| Est. Completion | 2019-06-21 |
| Phase | Phase 4 |
What the finished NCT03077711 record still lists
NCT03077711 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Trimethoprim is the first listed.
NCT03077711 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03077711 about?
NCT03077711 is a clinical study titled "Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs". 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 literat...
What is the current status of trial NCT03077711?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 92 participants. The study started on 2016-06. Estimated completion is 2019-06-21.
What interventions are being tested in trial NCT03077711?
The interventions under investigation include: Trimethoprim (DRUG), Methenamine hippurate (DRUG).
Who is sponsoring clinical trial NCT03077711?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03077711's enrollment target sits among peer trials
92 876th of 2000 higher than 1,117 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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