Short-course Methenamine Hippurate for Prevention of Post-operative UTI

• Status: Completed
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Ciprofloxacin; Methenamine; Methenamine hippurate; Methenamine mandelate

Criteria

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.