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Silver-Coated vs Standard Catheter for UTI Prevention

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TriHealth

Status

Completed

Conditions

UTI

Treatments

Device: 2-Way Foley Urethral Urinary Catheter

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

310 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

310 participants in 2 patient groups, including a placebo group

Silver-Coated Catheter
Active Comparator group
Treatment:
Device: 2-Way Foley Urethral Urinary Catheter
Standard Catheter
Placebo Comparator group
Treatment:
Device: 2-Way Foley Urethral Urinary Catheter

Trial contacts and locations

2

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Central trial contact

Kelsey Lewis, MD

Data sourced from clinicaltrials.gov

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