Overview

Urinary Track Infection Prevention After Urogynecological Surgery

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
TriHealth Inc.
Treatments:
Methenamine
Methenamine hippurate
Methenamine mandelate
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 <60 ml/min/1.73 m² or serum creatinine level >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