GIVEIT: Gentamicin Intravesical Efficacy for Infection of Urinary Tract
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).
Arms and Interventions
|Active Comparator: Gentamicin Arm|
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.
Drug: gentamicin sulfate
Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter.
|Sham Comparator: Control Arm|
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.
Other: Catheter clamping only
Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm.
Primary Outcome Measures
- Post-operative urinary tract infection [Within 6 weeks after surgery]
The proportion of subjects in each arm treated with antibiotics for urinary tract infection symptoms
Secondary Outcome Measures
- Adverse events [Within 6 weeks after surgery]
The proportion of subjects in each arm with an untoward or unfavorable medical occurrence in a subject, including any abnormal sign (physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the study, whether or not considered related to the subject's participation in the research
- Urine culture results [Within 6 weeks after surgery]
Results of any urine cultures obtained following patient reporting of urinary tract infection symptoms
- Treatment of urinary symptoms with negative urine culture [Within 6 weeks after surgery]
Number of times in each study arm that a subject is treated for urinary tract symptoms but ultimately has a negative urine culture
- Genitourinary microbiome effects [Perioperative (immediately pre-operative and immediately post-operative)]
Results of immediately pre-operative and post-operative urinary and vaginal microbiome samples (UCSD site only)
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
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
Contacts and Locations
|1||UC San Diego Health||La Jolla||California||United States||92037|
|2||Kaiser Permanente San Diego||San Diego||California||United States||92123|
Sponsors and Collaborators
- Kaiser Permanente
- University of California, San Diego
- Principal Investigator: Kimberly L Ferrante, M.D., M.A.S., Kaiser Permanente
- Principal Investigator: Marianna Alperin, M.D., M.S., UC San Diego Health
Study Documents (Full-Text)None provided.