Recruiting

Methenamine vs. Antibiotic

Sponsor:

Atlantic Health System

Code:

NCT06810687

Conditions

Urinary Tract Infection (Diagnosis)

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Methenamine Hippurate 1g BD

Antibiotic prophylaxis

Study Details

Brief 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.

Conditions

Urinary Tract Infection (Diagnosis)

Study ID

NCT06810687

Start date

Jan 30, 2025

Status verified date

Jan, 2025

Completion date

Jan 30, 2028

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Female
2. Age ≥ 18
3. Patients undergoing mid-urethral sling procedure

Exclusion Criteria:

1. Medication intolerance or allergy to study medications
2. Renal impairment with GFR <30
3. Breast feeding
4. Pregnancy
5. Recurrent urinary tract infections
6. Active urinary tract infection
7. Immunosuppressive disease
8. Interstitial cystitis

Study Design

Enrollment

190 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Methenamine prophylaxis

Methenamine will be prescribed for urinary tract infection prophylaxis

active comparator: Antibiotic prophylaxis

Antibiotic prophylaxis chosen per physician preference

Interventions

Methenamine Hippurate 1g BD

Antibiotic prophylaxis

Antibiotic prophylaxis

Antibiotic prophylaxis

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Atlantic Health

Recruiting

Morristown, New Jersey, United States, 07928

Contacts

Principal Investigator:

Shaun Adair, MD

More Information

Sponsor

Atlantic Health System

Last update posted

Feb 7, 2025

Last verified

Jan, 2025

Keywords

  • urinary tract infection
  • midurethral sling
  • prophylaxis
  • methenamine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Health System on 2025-02-07.