Actively Recruiting
Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis? A Randomized Controlled Trial
Led by Atlantic Health System · Updated on 2025-02-07
190
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Stress urinary incontinence (SUI) affects a significant number of women, with synthetic polypropylene mid-urethral slings (MUS) being the standard treatment. However, post-operative urinary tract infections (UTIs) are common complications after MUS, occurring in up to 21-34% of cases. This study aims to evaluate whether methenamine, a urinary antiseptic, is as effective as antibiotic prophylaxis in preventing UTIs after MUS placement, addressing concerns over antibiotic resistance and treatment failures. Participants will be randomly assigned to receive either methenamine hippurate or antibiotic prophylaxis after their MUS procedure. The methenamine group will take 1g twice daily, while the antibiotic group will receive prophylaxis according to physician preference. The study focuses on the 6-week period following the surgery to monitor for UTIs and related adverse effects. During the trial, participants will be monitored for the incidence of UTIs within 6 weeks post-procedure, adverse effects, and any additional treatments needed for UTIs. Researchers will collect data on these outcomes to compare the two prophylactic strategies. The study is open to females aged 18 to 100 undergoing the MUS procedure, and participation includes follow-up visits and assessments within the 6-week timeframe.
CONDITIONS
Brief Title
Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age 18 years or older
- Undergoing mid-urethral sling procedure
You will not qualify if you...
- Allergy or intolerance to study medications
- Kidney impairment with GFR less than 30
- Breastfeeding
- Pregnancy
- Recurrent urinary tract infections
- Active urinary tract infection
- Immunosuppressive disease
- Interstitial cystitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks after the procedure
Participants receive either methenamine or antibiotic prophylaxis after their mid-urethral sling procedure to prevent urinary tract infection.
1 baseline visit and weekly visits for up to 6 weeks
Duration - Up to 6 weeks after the procedure
Participants are monitored for adverse effects and any additional treatments for urinary tract infection following the prophylaxis period.
Weekly visits for up to 6 weeks
Trial Site Locations
Total: 1 location
1
Atlantic Health
Morristown, New Jersey, United States, 07928
Actively Recruiting
Research Team
R
Rena Ow, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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