Back to resultsGentamicin Intravesical Efficacy for Infection of Urinary Tract (GIVEIT)
Primary Purpose
Postoperative Urinary Tract Infection, Pelvic Organ Prolapse, Stress Urinary Incontinence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gentamicin sulfate
Catheter clamping only
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Urinary Tract Infection focused on measuring gentamicin sulfate, pelvic organ prolapse surgery, midurethral sling, bladder instillation
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
Sites / Locations
- UC San Diego Health
- Kaiser Permanente San Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Gentamicin Arm
Control Arm
Arm 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.
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.
Outcomes
Primary Outcome Measures
Post-operative Urinary Tract Infection
Number of participants in each arm treated with antibiotics for urinary tract infection symptoms
Secondary Outcome Measures
Adverse Events
Hospital readmissions
Number of Participants With Isolated Uropathogen on Post-operative Urine Culture
Full Information
NCT ID
NCT04246996
First Posted
January 27, 2020
Last Updated
October 17, 2022
Sponsor
Kaiser Permanente
Collaborators
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT04246996
Brief Title
Gentamicin Intravesical Efficacy for Infection of Urinary Tract
Acronym
GIVEIT
Official Title
Gentamicin Intravesical Efficacy for Infection of Urinary Tract
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 29, 2020 (Actual)
Primary Completion Date
December 5, 2021 (Actual)
Study Completion Date
December 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Urinary Tract Infection, Pelvic Organ Prolapse, Stress Urinary Incontinence
Keywords
gentamicin sulfate, pelvic organ prolapse surgery, midurethral sling, bladder instillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
370 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gentamicin Arm
Arm Type
Active Comparator
Arm 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.
Arm Title
Control Arm
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
gentamicin sulfate
Other Intervention Name(s)
gentamicin sulfate transurethral bladder instillation with catheter clamping for 1 hour
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Catheter clamping only
Intervention Description
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 Measure Information:
Title
Post-operative Urinary Tract Infection
Description
Number of participants in each arm treated with antibiotics for urinary tract infection symptoms
Time Frame
Within 6 weeks after surgery
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Hospital readmissions
Time Frame
Within 6 weeks after surgery
Title
Number of Participants With Isolated Uropathogen on Post-operative Urine Culture
Time Frame
Within 6 weeks after surgery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
All subjects will be female because undergoing surgery for female pelvic organ prolapse and stress urinary incontinence is an inclusion criterion.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly L Ferrante, M.D., M.A.S.
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marianna Alperin, M.D., M.S.
Organizational Affiliation
UC San Diego Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Kaiser Permanente San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gentamicin Intravesical Efficacy for Infection of Urinary Tract
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