Gentamicin Intravesical Efficacy for Infection of Urinary Tract

Phase 2

Completed

Conditions: Pelvic Organ Prolapse
Postoperative Urinary Tract Infection
Stress Urinary Incontinence

Brief 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).

Recruitment & Eligibility

Inclusion Criteria

Adult women undergoing pelvic organ prolapse surgery and/or stress urinary incontinence surgery with surgical plan for at least 1 cystoscopy and will leave the operating room with a standard-of-care transurethral catheter.
Negative urine culture within 4 weeks or completion of UTI treatment ≥48 hours prior to surgery

Exclusion Criteria

History of allergic reaction or anaphylaxis to gentamicin sulfate or to sodium metabisulfite (one of the preservatives in the gentamicin sulfate product)
Abnormal intraoperative urinary tract finding (e.g. bladder mass, stone, or fistula)
Intraoperative urinary tract injury
Suppressive recurrent UTI treatment
Chronic indwelling catheter/self-catheterization
Unable to provide informed consent
Severe renal impairment - glomerular filtration rate of less than 30 mL / minute
Current pregnancy
Currently incarcerated

Arm && Interventions

Group	Intervention	Description
Gentamicin Arm	gentamicin sulfate	At the completion of the subjects surgery but prior to awakening from anesthesia, 80mg of gentamicin in 50 mL of normal saline will be infused into the subject's bladder through the standard-of-care transurethral catheter by the surgeon. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
Control Arm	Catheter clamping only	If the patient is randomized to no instillation, at the end of the surgery but prior to awakening from anesthesia, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for subjects receiving usual care will be to ensure patients are masked to study arm assignment if they wake up and notice their catheter. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.

Primary Outcome Measures

Name	Time	Method
Post-operative Urinary Tract Infection	Within 6 weeks after surgery	Number of participants in each arm treated with antibiotics for urinary tract infection symptoms

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Isolated Uropathogen on Post-operative Urine Culture	Within 6 weeks after surgery
Adverse Events	Within 6 weeks after surgery	Hospital readmissions