CompletedPhase 2

Gentamicin Intravesical Efficacy for Infection of Urinary Tract

United States370 participantsStarted 2020-01-29

Plain-language 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).

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Post-operative Urinary Tract Infection

Timeframe: Within 6 weeks after surgery

Trial details

NCT IDNCT04246996

SponsorKaiser Permanente

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-05

Results submitted2022-09-21