Silver-Coated vs Standard Catheter for UTI Prevention

UTI Clinical Trial

Official title:

Silver-coated Catheter Versus Standard Catheter for UTI Prevention in a Short-term Transurethral Indwelling Catheter Population After Pelvic Reconstructive Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05408533
• Other study ID #: 22-004
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2024
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Aim: To determine whether silver-coated transurethral catheter decreases the incidence of culture-confirmed urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery

Secondary Aims:

To assess difference in bacterial uropathogens isolated in urine cultures Adverse symptoms possibly caused by silver-coated catheter

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 310
• Est. completion date: June 1, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who undergo major or minor pelvic organ prolapse surgery of any compartment, or urinary incontinence surgery that are diagnosed with POUR via failed retrograde voiding trial and require an indwelling transurethral catheter upon hospital discharge. Sacral neuromodulation procedures and intradetrusor onabotulinumtoxinA (Botox) injections are excluded.

Exclusion Criteria:

• Unwilling or unable to participate in the study.

• Unwilling or unable to do a catheter self-removal at home.

• Inability to understand English.

• Pregnant women

• Patient personal history of urogenital anomaly, neurogenic bladder, use of chronic self-intermittent catheterization or suprapubic tubes, ureteral stents or other genitourinary indwelling devices, immunosuppressed state or chronic use of steroids.

• Currently (prior 3 months) undergoing medical management for recurrent UTI or interstitial cystitis

• Active urinary tract infection.

• Intraoperative bladder injury or cystotomy

• Physical or mental impairment that would affect the subject's ability to perceive urinary tract infection symptoms

• Reported allergy to silver metal

Related Conditions & MeSH terms

• UTI

Intervention

Device:
• 2-Way Foley Urethral Urinary Catheter
Comparing two types of catheter (silver-coated silicone versus silicone) after Pelvic Reconstructive Surgery (PRS) to compare Urinary Tract Infection (UTI) rates

Locations

Country	Name	City	State
United States	Cincinnati Urogynecology Associates	Cincinnati	Ohio
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of UTIs requiring treatment	Post-operative UTI rate	approximately 4 weeks
Secondary	Assess the types of bacterial uropathogens isolated from the urine cultures		approximately 4 weeks
Secondary	Adverse symptoms possibly causes by silver-coated catheter		approximately 4 weeks