Gentamicin Intravesical Efficacy for Infection of Urinary Tract (GIVEIT)

• ClinicalTrials.gov Identifier: NCT04246996
• Recruitment Status: Completed
• First Posted: January 29, 2020
• Results First Posted: November 8, 2022
• Last Update Posted: November 8, 2022
• Sponsor: Kaiser Permanente
• Collaborator: University of California, San Diego
• Information provided by (Responsible Party): Kaiser Permanente

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 (Clinical Trial)
• Actual Enrollment: 370 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: January 29, 2020
• Actual Primary Completion Date: December 5, 2021
• Actual Study Completion Date: December 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 Name: 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 :

1. Post-operative Urinary Tract Infection [ Time Frame: Within 6 weeks after surgery ]
   Number of participants in each arm treated with antibiotics for urinary tract infection symptoms

Secondary Outcome Measures :

1. Adverse Events [ Time Frame: Within 6 weeks after surgery ]
   Hospital readmissions
2. Number of Participants With Isolated Uropathogen on Post-operative Urine Culture [ Time Frame: Within 6 weeks after surgery ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: 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.
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

UC San Diego Health

La Jolla, California, United States, 92037

Kaiser Permanente San Diego

San Diego, California, United States, 92123

Sponsors and Collaborators

Kaiser Permanente

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 Documents (Full-Text)

Documents provided by Kaiser Permanente:

Study Protocol and Statistical Analysis Plan  [PDF] June 9, 2020

More Information

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT04246996
• Other Study ID Numbers: GIVEIT; 12297 ( Other Identifier: Kaiser Permanente Southern California IRB ); 191835 ( Other Identifier: UC San Diego Health IRB )
• First Posted: January 29, 2020
• Results First Posted: November 8, 2022
• Last Update Posted: November 8, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaiser Permanente:

gentamicin sulfate; pelvic organ prolapse surgery; midurethral sling; bladder instillation

Additional relevant MeSH terms:

Infections; Communicable Diseases; Urinary Tract Infections; Urinary Incontinence; Urinary Incontinence, Stress; Prolapse; Pelvic Organ Prolapse; Disease Attributes; Pathologic Processes; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Anatomical; Gentamicins; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action