Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling As Effective As Antibiotic Prophylaxis? a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: t
View:

• Female

• Age ≥ 18

• Patients undergoing mid-urethral sling procedure

Locations
United States
New Jersey
Atlantic Health
RECRUITING
Morristown
Contact Information
Primary
Rena Ow, MD
rena.ow@atlantichealth.org
9739717267
Time Frame
Start Date: 2025-01-30
Estimated Completion Date: 2028-01-30
Participants
Target number of participants: 190
Treatments
Experimental: Methenamine prophylaxis
Methenamine will be prescribed for urinary tract infection prophylaxis
Active_comparator: Antibiotic prophylaxis
Antibiotic prophylaxis chosen per physician preference
Sponsors
Leads: Atlantic Health System

This content was sourced from clinicaltrials.gov