Gentamicin Intravesical Efficacy for Infection of Urinary Tract

Study Overview
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Brief Summary
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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).

Official Title
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Gentamicin Intravesical Efficacy for Infection of Urinary Tract

Conditions
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Postoperative Urinary Tract Infection, Pelvic Organ Prolapse, Stress Urinary Incontinence

Intervention / Treatment
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* Drug: gentamicin sulfate
* Other: Catheter clamping only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gentamicin Arm<br>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<br>* 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.<br>* Other names: gentamicin sulfate transurethral bladder instillation with catheter clamping for 1 hour;|
| Sham Comparator: Control Arm<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Urinary Tract Infection | Number of participants in each arm treated with antibiotics for urinary tract infection symptoms | Within 6 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Hospital readmissions | Within 6 weeks after surgery | 
| Number of Participants With Isolated Uropathogen on Post-operative Urine Culture |  | Within 6 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gentamicin sulfate, pelvic organ prolapse surgery, midurethral sling, bladder instillation