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NCT04246996 Clinical Trial

Gentamicin Intravesical Efficacy for Infection of Urinary Tract

Pelvic Organ Prolapse Clinical Trial

— GIVEIT  

Official title:
Gentamicin Intravesical Efficacy for Infection of Urinary Tract

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04246996
Other study ID # GIVEIT
Secondary ID 12297191835
Status Completed
Phase Phase 2
First received
Last updated
Start date January 29, 2020
Est. completion date December 5, 2021

Study information
Verified date October 2022
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 370
Est. completion date December 5, 2021
Est. primary completion date December 5, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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:
• 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.

Locations
Country Name City State
United States UC San Diego Health La Jolla California
United States Kaiser Permanente San Diego San Diego California

Sponsors (2)
Lead Sponsor Collaborator
Kaiser Permanente University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Adverse Events Hospital readmissions Within 6 weeks after surgery
Secondary Number of Participants With Isolated Uropathogen on Post-operative Urine Culture Within 6 weeks after surgery
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