Phase 2 Completed N=370 Randomized Single-blind Prevention

Gentamicin Intravesical Efficacy for Infection of Urinary Tract

Postoperative Urinary Tract Infection · pelvic organ prolapse · Stress Urinary Incontinence

Source: ClinicalTrials.gov NCT04246996 ↗

Enrolled (actual)

370

Serious AEs

3.0%

Results posted

Nov 2022

Primary outcomePrimary: Post-operative Urinary Tract Infection — 19; 20 Participants

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).

Outcome Measures

Outcome	Result	p-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	—

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. Informational only — not medical advice.