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Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis?

NCT06810687 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-02-07

No results posted yet for this study

Summary

Stress urinary incontinence (SUI) affects at least 40% of women in the United States. Synthetic polypropylene mid-urethral slings (MUS) are the gold standard treatment for SUI. Post-operative urinary tract infections (UTI) are one of the most common complications after MUS placement. Some studies have demonstrated that MUS placement can increase the risk of UTI up to 21-34%.

Post-operative UTI can lead to significant healthcare and patient burden. This additional burden further contributes to an estimated annual cost of $1.6 billion for UTI management in the United States. With increased antibiotic usage, there is simultaneous increase in bacterial resistance leading to treatment refractory UTI.

The investigators prescribe post-operative antibiotics prophylactically for 3 days after MUS placement with or without concurrent pelvic reconstructive surgery based on prior literature recommending post-operative prophylaxis. There is a greater emphasis on limiting antibiotic use given the trend of development of bacterial resistance. There are studies supporting alternatives such as methenamine for recurrent UTI prophylaxis treatment, but there are limited studies evaluating methenamine for UTI prophylaxis after MUS.

Conditions

  • Urinary Tract Infection (Diagnosis)

Interventions

DRUG

Methenamine Hippurate 1g BD

Antibiotic prophylaxis

OTHER

Antibiotic prophylaxis

Antibiotic prophylaxis

Sponsors & Collaborators

  • Atlantic Health System

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-30
Primary Completion
2027-07-30
Completion
2028-01-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06810687 on ClinicalTrials.gov