Summary

for females ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion
Marianna Alperin, M.D., M.S.

Description

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).

Keywords

Postoperative Urinary Tract Infection Pelvic Organ Prolapse Stress Urinary Incontinence gentamicin sulfate pelvic organ prolapse surgery midurethral sling bladder instillation Infection Communicable Diseases Urinary Tract Infections Urinary Incontinence Urinary Incontinence, Stress Prolapse Gentamicins Catheter clamping only

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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 CAN'T join 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

Locations

  • UC San Diego Health not yet accepting patients
    La Jolla California 92037 United States
  • Kaiser Permanente San Diego accepting new patients
    San Diego California 92123 United States

Lead Scientist

  • Marianna Alperin, M.D., M.S.
    Associate Professor, Reproductive Medicine. Authored (or co-authored) 42 research publications. Research interests: Women's Health · Pelvic Floor Disorders · Childbirth Injury · Biological Senescence

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kaiser Permanente
ID
NCT04246996
Phase
Phase 2
Study Type
Interventional
Last Updated