Gentamicin Intravesical Efficacy for Infection of Urinary Tract

• Status: Recruiting
• Trial end date: 2021-07-30
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaiser Permanente
• Collaborator: University of California, San Diego
• Treatments: Gentamicins

Criteria

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