Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis?
Atlantic Health System · NCT06810687
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–100 · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 190
- US sites recruiting
- 1
- Study start
- January 30, 2025
- Record last updated
- February 7, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Methenamine Hippurate 1g BD; Antibiotic prophylaxis
Conditions: Urinary Tract Infection (Diagnosis)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Female
- Age ≥ 18
- Patients undergoing mid-urethral sling procedure
Exclusion Criteria
- Medication intolerance or allergy to study medications
- Renal impairment with GFR \<30
- Breast feeding
- Pregnancy
- Recurrent urinary tract infections
- Active urinary tract infection
- Immunosuppressive disease
- Interstitial cystitis
Recruiting US locations
Atlantic Health
Morristown, NJ 07928
Site contact: Rena Ow, MD · 9739717267 · rena.ow@atlantichealth.org
Study contacts (from the official record)
- Rena Ow, MD · 9739717267 · rena.ow@atlantichealth.org
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