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
2
Locations
2
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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

    1. 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

    1. 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

    2. Urine culture results [Within 6 weeks after surgery]

      Results of any urine cultures obtained following patient reporting of urinary tract infection symptoms

    3. 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

    4. 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:
    No
    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

    SiteCityStateCountryPostal Code
    1UC San Diego HealthLa JollaCaliforniaUnited States92037
    2Kaiser Permanente San DiegoSan DiegoCaliforniaUnited States92123

    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)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kaiser Permanente
    ClinicalTrials.gov Identifier:
    NCT04246996
    Other Study ID Numbers:
    • GIVEIT
    • 12297
    • 191835
    First Posted:
    Jan 29, 2020
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 15, 2022