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OpenTrials
Completed

NCT Number: NCT04246996

Gentamicin Intravesical Efficacy for Infection of Urinary Tract

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).

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Key information

Conditions

Postoperative Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Signs and Symptoms Stress Urinary Incontinence Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

UC San Diego Health, La Jolla, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gentamicin Sulfate

Drug

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

Catheter clamping only

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • University of California, San Diego

Registry information

Acronym: GIVEIT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 29, 2020
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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