CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 185 enrolled
Drug / intervention
Methenamine Hippurate 1 g tablet +1 moredrug
Likely dose
Methenamine Hippurate 1 g tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03818321
NCT03818321Phase 2Completed
CompareCT.gov

Methenamine Hippurate With Cranberry Capsules Versus Cranberry Capsules Alone for UTI Prevention in a Short-term Indwelling Foley Catheter Population After Urogynecological Surgery: A Double-Blinded Randomized Controlled Trial

TriHealth Inc.·interventional·Posted Jan 28, 2019·Updated Nov 14, 2022

In Brief

A Phase 2 clinical trial evaluating Methenamine Hippurate 1 g tablet and Placebo tablet for Urinary Tract Infections and 2 related conditions. Completed, enrolled 185 participants across 1 site.

Detailed Summary

This study is randomized double-blinded placebo-controlled trial to access oral Methenamine Hippurate (MH) in combination with cranberry capsules is superior to cranberry capsules alone in prevention of UTI in patients with transient post-operative urinary retention requiring a Foley catheter after pelvic reconstructive surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Tract Infections, Urinary Retention Postoperative, Pelvic Organ Prolapse
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 28, 2019
Enrollment StartJun 17, 2019
Primary CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.4 years ago

Interventions

Methenamine Hippurate 1 g tabletdrug

Methenamine Hippurate (study drug) is an FDA approved medication in the prevention of UTI. Methenamine Hippurate 1g contains Hippuric acid salt of Methenamine (hexamethylene tetramine), Magnesium Stearate, Povidone, Saccharin Sodium, FD\&C Yellow No. 5 (tartrazine) (www.iodine.com/drug/hiprex/fda-package-insert).

Placebo tabletdrug

Placebo is a tablet that will be provided to you that looks like the study drug but does not contain any medication. These pills are comprised of gelatin and minimal amounts of lactose powder. The pills are designed to have no effect on the patient.