Urinary Track Infection Prevention After Urogynecological Surgery

Completed · Phase 2 · Has a placebo group

Conditions studied: Urinary Tract Infections, Urinary Retention Postoperative, Pelvic Organ Prolapse

In brief

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.

Key facts

Study ID

NCT03818321

Run by

TriHealth Inc.

People needed

185

Starts

2019-06-17

Expected to finish

2021-07-01

Last updated by the study team

2022-11-14

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Cincinnati Urogynecology Associates — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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