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