At a glance
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Gentamicin Intravesical Efficacy for Infection of Urinary Tract
In Brief
A Phase 2 clinical trial evaluating gentamicin sulfate and Catheter clamping only for Postoperative Urinary Tract Infection and 2 related conditions. Completed, enrolled 370 participants across 2 sites.
Detailed Summary
Urinary tract infection (UTI) is a common problem after surgery for pelvic organ prolapse and stress urinary incontinence. This prospective, randomized, single-masked (subject), two-parallel armed study aims to determine the effect of a single postoperative intravesical instillation of 80 mg of gentamicin sulfate in 50 mL of saline versus usual care on the proportion of women treated for UTI within 6 weeks following surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
Study Details
Timeline
Interventions
Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter.
Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm.