GIVEIT: Gentamicin Intravesical Efficacy for Infection of Urinary Tract

Sponsor

Kaiser Permanente (Other)

Overall Status

Completed

CT.gov ID

NCT04246996

Collaborator

University of California, San Diego (Other)

368

Enrollment

Locations

Arms

22.2

Actual Duration (Months)

184

Patients Per Site

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Postoperative Urinary Tract Infection Pelvic Organ Prolapse Stress Urinary Incontinence	Drug: gentamicin sulfate Other: Catheter clamping only	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

368 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

The subject will be masked as to whether she has been assigned to the gentamicin arm or the control arm. The subject will be unmasked at the completion of the 6 week follow up period.

Primary Purpose:

Prevention

Official Title:

Gentamicin Intravesical Efficacy for Infection of Urinary Tract

Actual Study Start Date :

Jan 29, 2020

Actual Primary Completion Date :

Dec 5, 2021

Actual Study Completion Date :

Dec 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
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. Other Names: gentamicin sulfate transurethral bladder instillation with catheter clamping for 1 hour
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.

Arm

Intervention/Treatment

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.

Other Names:

gentamicin sulfate transurethral bladder instillation with catheter clamping for 1 hour

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.

Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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