Catheter-Related Infections, Urinary Tract Infections, Urogynecologic Surgery
Conditions
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.
Interventions
DEVICEFoley Catheter vs Self-Contained Valved Catheter
This study aims to compare UTI rates and patient satisfaction between an indwelling Foley catheter group (established SOC); and a relatively (FDA-approved) new valved addition to the Foley catheter which requires no drainage bag.
Sponsors
charbel salamon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This study aim is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter vs a valved catheter in patients who are being discharged home with a catheter after urogynecologic proecures via a Randomized Clinical Trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter.
Exclusion criteria
* Intra-operative bladder injury during index surgery * Intra-operative complication requiring continuous bladder drainage * Dementia / altered cognitive function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of urinary tract infections | Up to 4 weeks after surgery | Number of urine cultures positive for infection (taken at voiding trial visit and post-operative visit). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | Up to 5 days after surgery | Foley satisfaction questionnaire will be collected at post-operative voiding trial office visit. |
| Number of days until spontaneous void/Number of calls for device-related issues | Up to 4 weeks after surgery | Number of days until spontaneous void and number of call for device-related issues. |
Countries
United States
Outcome results
None listed