What this study is
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.
What's being tested
- Methenamine Hippurate 1g BD
Intervention · DRUG
- Antibiotic prophylaxis
Intervention · OTHER
Both interventions
Antibiotic prophylaxis
Study details
- Official title
- Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis? A Randomized Controlled Trial
- Sponsor
- Atlantic Health System
- Conditions
- Urinary Tract Infection (Diagnosis)
- Enrolling
- 190 people
- Starts
- 2025-01-30
- Est. completion
- 2028-01-30
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex FEMALEHealthy volunteers AcceptedYou may qualify if
- Female
- Age ≥ 18
- Patients undergoing mid-urethral sling procedure
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openAtlantic Health
Morristown, New Jersey, United States
- Rena Ow, MD · Contact9739717267rena.ow@atlantichealth.org
- Shaun Adair, MD · Principal investigator
Recruiting
Study team
Sponsor
Atlantic Health System
Study ID 2248168-1
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.