Gentamicin Intravesical Efficacy for Infection of Urinary Tract

NCT ID: NCT04246996

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-29
• Study Completion Date: 2021-12-05

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).

Conditions

Postoperative Urinary Tract Infection; Pelvic Organ Prolapse; Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

gentamicin sulfate

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Catheter clamping only

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

gentamicin sulfate transurethral bladder instillation with catheter clamping for 1 hour

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly L Ferrante, M.D., M.A.S.

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Marianna Alperin, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

UC San Diego Health

Locations

UC San Diego Health

La Jolla, California, United States

Kaiser Permanente San Diego

San Diego, California, United States

Countries

United States

References

Rieger MM, Shah NM, Ferrante KL, Tan-Kim J, Jacobs MB, Brubaker L, Alperin M. Intraoperative Gentamicin Intravesical Instillation for Prevention of Urinary Tract Infection After Urogynecologic Surgery: A Randomized Controlled Trial. Urogynecology (Phila). 2022 Dec 1;28(12):825-833. doi: 10.1097/SPV.0000000000001233. Epub 2022 Aug 23.

Reference Type: DERIVED

PMID: 36409639 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

12297

Identifier Type: OTHER

Identifier Source: secondary_id

191835

Identifier Type: OTHER

Identifier Source: secondary_id

GIVEIT

Identifier Type: -

Identifier Source: org_study_id