Urinary Track Infection Prevention After Urogynecological Surgery (NCT03818321) | Clinical Trial Compass
CompletedPhase 2
Urinary Track Infection Prevention After Urogynecological Surgery
United States185 participantsStarted 2019-06-17
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Urinary Track Infection (UTI)
Timeframe: From surgery to one week post-op visit, approximately 1 week post surgery