Gentamicin Intravesical Efficacy for Infection of Urinary Tract (GIVEIT)

Kaiser Permanente

Status and phase: Completed; Phase 2

Conditions: Postoperative Urinary Tract Infection; Stress Urinary Incontinence; Pelvic Organ Prolapse

Treatments: Other: Catheter clamping only; Drug: gentamicin sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04246996

191835 (Other Identifier)

GIVEIT

12297 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 370 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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370 participants in 2 patient groups

Gentamicin Arm

Active Comparator group

Description:

At the completion of the subjects surgery but prior to awakening from anesthesia, 80mg of gentamicin in 50 mL of normal saline will be infused into the subject's bladder through the standard-of-care transurethral catheter by the surgeon. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.

Treatment:

Drug: gentamicin sulfate

Control Arm

Sham Comparator group

Description:

If the patient is randomized to no instillation, at the end of the surgery but prior to awakening from anesthesia, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for subjects receiving usual care will be to ensure patients are masked to study arm assignment if they wake up and notice their catheter. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.

Treatment:

Other: Catheter clamping only