Gentamicin Intravesical Efficacy for Infection of Urinary Tract
Completed · Phase 2
Conditions studied: Postoperative Urinary Tract Infection, Pelvic Organ Prolapse, Stress Urinary Incontinence
In brief
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).
Key facts
- Study ID
- NCT04246996
- Run by
- Kaiser Permanente
- People needed
- 370
- Starts
- 2020-01-29
- Expected to finish
- 2021-12-05
- Last updated by the study team
- 2022-11-08
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UC San Diego Health — La Jolla, California, United States
- Kaiser Permanente San Diego — San Diego, California, United States
Full record on ClinicalTrials.gov
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