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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorAtlantic Health System

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Female

Age ≥ 18

Patients undergoing mid-urethral sling procedure

Disqualifiers

Medication intolerance or allergy to study medications

Renal impairment with GFR <30

Breast feeding

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methenamine Hippurate 1g BD

    Drug

    Antibiotic prophylaxis

  • Antibiotic prophylaxis

    Other intervention

    Antibiotic prophylaxis

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: Methenamine prophylaxisExperimental treatment 1 intervention
Group B: Antibiotic prophylaxisActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of urinary tract infection

Urinary tract infection (Positive urine culture) within 6 weeks post-operatively after completing 3 days of antibiotics or methenamine

Time frame
Within 6 weeks after the procedure

Secondary outcomes

1

Number of participants with adverse effects

Adverse effects or side effects of treatment

Time frame
within 6 weeks after the procedure
2

Occurrence of additional treatment of UTI

Further treatment antibiotics given to participants

Time frame
Within 6 weeks after the procedure

Other outcomes

Sponsors and contacts

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