Gentamicin Intravesical Efficacy for Infection of Urinary Tract

NCT04246996 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: GIVEIT12297191835
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adverse Events

  Within 6 weeks after surgery

• Number of Participants With Isolated Uropathogen on Post-operative Urine Culture

  Within 6 weeks after surgery

Study Arms (2)

Gentamicin Arm

ACTIVE COMPARATOR

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

Control Arm

SHAM COMPARATOR

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

Interventions

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.

Also known as: gentamicin sulfate transurethral bladder instillation with catheter clamping for 1 hour

Gentamicin Arm

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.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All subjects will be female because undergoing surgery for female pelvic organ prolapse and stress urinary incontinence is an inclusion criterion.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• University of California, San Diego: collaborator

Study Sites (2)

UC San Diego Health

La Jolla, California, 92037, United States

Location

Kaiser Permanente San Diego

San Diego, California, 92123, United States

Location

Related Publications (1)

• 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.

  PMID: 36409639 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Mary Rieger, MD, MAS
• Organization: Dell Medical School at The University of Texas at Austin

mary.rieger@austin.utexas.edu

512-324-7036

Study Officials

• Kimberly L Ferrante, M.D., M.A.S.

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Marianna Alperin, M.D., M.S.

  UC San Diego Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: January 29, 2020
• Primary Completion: December 5, 2021
• Study Completion: December 5, 2021
• Last Updated: November 8, 2022
• Results First Posted: November 8, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)