Gentamicin Intravesical Efficacy for Infection of Urinary Tract (GIVEIT)

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).

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Stress Urinary Incontinence; Postoperative Urinary Tract Infection
• Intervention / Treatment: Drug: gentamicin sulfate; Other: Catheter clamping only

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • UC San Diego Health
    • San Diego, California, United States, 92123
      • Kaiser Permanente San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: University of California, San Diego
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Actual): December 5, 2021
• Study Completion (Actual): December 5, 2021

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: gentamicin sulfate; pelvic organ prolapse surgery; midurethral sling; bladder instillation
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Disease Attributes; Urination Disorders; Pathological Conditions, Anatomical; Urinary Incontinence; Infections; Communicable Diseases; Prolapse; Pelvic Organ Prolapse; Urinary Tract Infections; Urinary Incontinence, Stress; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins
• Other Study ID Numbers: GIVEIT; 12297 (Other Identifier: Kaiser Permanente Southern California IRB); 191835 (Other Identifier: UC San Diego Health IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No