Phase 2 Completed N=185 Randomized Quadruple-blind Prevention

Urinary Track Infection Prevention After Urogynecological Surgery

Urinary Tract Infections · Urinary Retention Postoperative · pelvic organ prolapse

Source: ClinicalTrials.gov NCT03818321 ↗

Enrolled (actual)

185

Serious AEs

0.0%

Results posted

Nov 2022

Primary outcomePrimary: Incidence of Urinary Track Infection (UTI) — 62; 71 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Urinary Track Infection (UTI)	62; 71	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.