Short-course Methenamine Hippurate for Prevention of Post-operative UTI (NCT02358993) | Clinical Trial Compass
CompletedNot Applicable
Short-course Methenamine Hippurate for Prevention of Post-operative UTI
United States201 participantsStarted 2014-12
Plain-language summary
The investigators will determine the efficacy of an innovative short regimen of methenamine hippurate on prevention of post-operative UTI in patients requiring short-term catheterization after pelvic reconstructive surgery through a single-blind, randomized controlled trial. Primary outcome will be the rate of symptomatic UTI within 3 weeks of catheter removal. The investigators will study cost-effectiveness, antibiotic resistance profiles, and adverse drug effects. Findings may reduce antibiotic use and nosocomial UTIs.
Who can participate
Age range
18 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:
* female;
* patients who are able to read and write English;
* 18 years of age or older;
* underwent surgery for pelvic organ prolapse, urinary incontinence, or both;
* require post-operative short-term transurethral catheterization for greater than 24 hours.
Exclusion Criteria:
* patients undergoing surgical intervention for sacral neuromodulation, or mesh excision;
* patients requiring long-term catheterization secondary to injury to the urinary tract;
* patients who pass their post-operative trial void and thus, do not require additional catheterization;
* patients requiring catheterization for less than 24 hours;
* pregnant patients;
* patients who are breast-feeding;
* allergy to methenamine hippurate or fluroquinolones (either ciprofloxacin or levofloxacin);
* impaired renal or hepatic function;
* pre-operative urinary retention;
* patients who are currently using sulfonamides;
* patients who have severe dehydration;
* patients using tizanidine;
* patients sensitive to quinolones class;
* patients using theophylline; patients with myasthenia gravis;
* patients with prolongation of QT interval.
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
Treatment of Clinically Suspected UTI - Using Intent to Treat Analysis
Timeframe: 3 weeks post-operative
2
Treatment of Clinically Suspected UTI - Per Protocol