Status:
COMPLETED
Urinary Track Infection Prevention After Urogynecological Surgery
Lead Sponsor:
TriHealth Inc.
Conditions:
Urinary Tract Infections
Urinary Retention Postoperative
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Urinary tract infections (UTIs) are one of the most common bacterial infections in women. It is estimated that 1.6 billion dollars are spent on UTI treatment each year. Antibiotics have been the mains...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT03818321
Start Date
June 17 2019
End Date
July 1 2021
Last Update
November 14 2022
Active Locations (1)
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1
Cincinnati Urogynecology Associates
Cincinnati, Ohio, United States, 45220