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Phase 2 N=370 Randomized Single-blind Prevention

Gentamicin Intravesical Efficacy for Infection of Urinary Tract

Postoperative Urinary Tract Infection · Pelvic Organ Prolapse · Stress Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT04246996 ↗
Enrolled (actual)
370
Serious AEs
3.0%
Results posted
Nov 2022
Primary outcome: Primary: Post-operative Urinary Tract Infection — 19; 20 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
gentamicin sulfate (Drug); Catheter clamping only (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Kaiser Permanente
Primary completion
Dec 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Post-operative Urinary Tract Infection		 19; 20 —
SECONDARY
Adverse Events		 5; 6 —
SECONDARY
Number of Participants With Isolated Uropathogen on Post-operative Urine Culture		 12; 15 —

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).

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04246996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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