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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
370
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.
UC San Diego Health
La Jolla, California, United States
Kaiser Permanente San Diego
San Diego, California, United States
Post-operative Urinary Tract Infection
Number of participants in each arm treated with antibiotics for urinary tract infection symptoms
Time frame: Within 6 weeks after surgery
Adverse Events
Hospital readmissions
Time frame: Within 6 weeks after surgery
Number of Participants With Isolated Uropathogen on Post-operative Urine Culture
Time frame: Within 6 weeks after surgery
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