Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-01-09 @ 11:26 AM
Study NCT ID:
NCT03178734
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2017-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Foley Catheter vs a Self-contained Valved Urinary Catheter
Sponsor:
charbel salamon
Organization:
Study Overview
Official Title:
Foley Catheter vs a Self-contained Valved Urinary Catheter for Patients Who Are Being Discharged Home With a Catheter After Urogynecologic Procedures
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial.
Detailed Description:
The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial. Total number of participants will be 100. Inclusion criteria is all patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter. Exclusion criteria is intra-operative bladder injury during index surgery; intra-operative complication requiring continuous bladder drainage; and/or dementia/altered cognitive function.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: