RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-30
Study Completion:2028-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06810687

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Female
  2. 2. Age ≥ 18
  3. 3. Patients undergoing mid-urethral sling procedure
  1. 1. Medication intolerance or allergy to study medications
  2. 2. Renal impairment with GFR \<30
  3. 3. Breast feeding
  4. 4. Pregnancy
  5. 5. Recurrent urinary tract infections
  6. 6. Active urinary tract infection
  7. 7. Immunosuppressive disease
  8. 8. Interstitial cystitis

Contacts and Locations

Study Contact

Rena Ow, MD
CONTACT
9739717267
rena.ow@atlantichealth.org

Study Locations (Sites)

Atlantic Health
Morristown, New Jersey, 07928
United States

Collaborators and Investigators

Sponsor: Atlantic Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-30
Study Completion Date2028-01-30

Study Record Updates

Study Start Date2025-01-30
Study Completion Date2028-01-30

Terms related to this study

Keywords Provided by Researchers

  • urinary tract infection
  • midurethral sling
  • prophylaxis
  • methenamine

Additional Relevant MeSH Terms

  • Urinary Tract Infection (Diagnosis)