N/A
Completed N=201
Short-course Methenamine Hippurate for Prevention of Post-operative UTI
Urinary Tract Infections · Catheter-Related Infections
Source: ClinicalTrials.gov NCT02358993 ↗
Enrolled (actual)
201
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Treatment of Clinically Suspected UTI - Using Intent to Treat Analysis — 13; 12 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment of Clinically Suspected UTI - Using Intent to Treat Analysis |
13; 12 | — |
| PRIMARY Treatment of Clinically Suspected UTI - Per Protocol |
12; 12 | — |
| SECONDARY Number of Participants With Culture-positive Symptomatic UTI |
5; 4 | — |
| SECONDARY Antibiotic Resistance of Culture-positive Symptomatic UTI |
0; 0 | — |
| SECONDARY Cost-effectiveness of Prophylaxis With Methenamine Hippurate for Prevention of Post-operative UTI Compared to Prophylaxis With Fluoroquinolones |
— | — |
| SECONDARY Prevalence of Side Effects |
— | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02358993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.