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

Part of paid clinical trials in Morristown, New Jersey.

Sponsor
Atlantic Health System
Study ID
NCT06810687
Status
Recruiting
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Conditions

  • Urinary Tract Infection (Diagnosis)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Methenamine Hippurate 1g BD — DRUG
    Antibiotic prophylaxis
  • Antibiotic prophylaxis — OTHER
    Antibiotic prophylaxis

Study Details

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.

Key Dates

Start date
Jan 30, 2025
Status verified
Jan 2025
Primary completion
Jul 30, 2027
Completion
Jan 30, 2028

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Methenamine prophylaxis
    Methenamine will be prescribed for urinary tract infection prophylaxis
  • Active Comparator: Antibiotic prophylaxis
    Antibiotic prophylaxis chosen per physician preference

Primary Outcome Measure

Incidence of urinary tract infection [ Time Frame: Within 6 weeks after the procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlantic HealthMorristownNew Jersey07928
Rena Ow, MD
[email protected]
9739717267
Shaun Adair, MD (PRINCIPAL_INVESTIGATOR)

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Atlantic Health· Morristown, NJ

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