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OpenTrials
Completed

NCT Number: NCT05408533

Silver-Coated vs Standard Catheter for UTI Prevention

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

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Key information

Conditions

UTI

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Urogynecology Associates, Cincinnati, Ohio, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2-Way Foley Urethral Urinary Catheter

Device

Comparing two types of catheter (silver-coated silicone versus silicone) after Pelvic Reconstructive Surgery (PRS) to compare Urinary Tract Infection (UTI) rates

Primary outcomes

  1. Incidence of UTIs requiring treatment

    Time frame: approximately 4 weeks

    Post-operative UTI rate

Secondary outcomes

  1. Assess the types of bacterial uropathogens isolated from the urine cultures

    Time frame: approximately 4 weeks

  2. Adverse symptoms possibly causes by silver-coated catheter

    Time frame: approximately 4 weeks

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2022
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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