Silver-Coated vs Standard Catheter for UTI Prevention

Not Applicable

Completed

• Conditions: UTI
• Interventions: Device: 2-Way Foley Urethral Urinary Catheter

• Registration Number: NCT05408533
• Lead Sponsor: TriHealth Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-29
• Study First Submitted QC: 2022-06-03
• Study First Posted: 2022-06-07
• Study Start: 2022-06-14
• Primary Completion: 2024-02-16
• Study Completion: 2024-05-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 310

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silver-Coated Catheter	2-Way Foley Urethral Urinary Catheter	-
Standard Catheter	2-Way Foley Urethral Urinary Catheter	-

Primary Outcome Measures

Name	Time	Method
Incidence of UTIs requiring treatment	approximately 4 weeks	Post-operative UTI rate

Secondary Outcome Measures

Name	Time	Method
Adverse symptoms possibly causes by silver-coated catheter	approximately 4 weeks
Assess the types of bacterial uropathogens isolated from the urine cultures	approximately 4 weeks

Trial Locations

Locations (2)

Cincinnati Urogynecology Associates; 🇺🇸 Cincinnati, Ohio, United States

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States