Status:
COMPLETED
Silver-Coated vs Standard Catheter for UTI Prevention
Lead Sponsor:
TriHealth Inc.
Conditions:
UTI
Eligibility:
FEMALE
18+ years
Phase:
NA
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 pelv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT05408533
Start Date
June 14 2022
End Date
May 1 2024
Last Update
November 25 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Cincinnati Urogynecology Associates
Cincinnati, Ohio, United States, 45220
2
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220