Phase 2
N=185
Urinary Track Infection Prevention After Urogynecological Surgery
Urinary Tract Infections · Urinary Retention Postoperative · Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT03818321 ↗Enrolled (actual)
185
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Incidence of Urinary Track Infection (UTI) — 62; 71 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Methenamine Hippurate 1 g tablet (Drug); Placebo tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- TriHealth Inc.
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Urinary Track Infection (UTI) |
62; 71 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients who undergo major pelvic organ prolapse surgery that are diagnosed with POUR via failed retrograde void trial and require an indwelling Foley catheter upon hospital discharge.
Exclusion Criteria
- Unwillingness to participate in the study
- Inability to understand English
- Pregnant women
- Patient personal history of nephrolithiasis, urogenital anomaly, neurogenic bladder, chronic renal insufficiency (GFR 1.03 for >3months), sarcoidosis, and severe hepatic insufficiency
- Currently (prior 3 months) undergoing medical management for recurrent UTI or interstitial cystitis
- Active urinary tract infection
- Patient history of taking Warfarin (Coumadin)
- Intraoperative bladder injury or cystotomy
- Physical or mental impairment that would affect the subject's ability to take medications daily or fill out questionnaires
- Reported allergy to any of the ingredients in the cranberry, MH, or placebo pill
Data sourced from ClinicalTrials.gov (NCT03818321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.