Foley Catheter vs a Self-contained Valved Urinary Catheter

charbel salamon

Status: Completed

Conditions: Urinary Tract Infections; Urogynecologic Surgery; Catheter-Related Infections

Treatments: Device: Foley Catheter vs Self-Contained Valved Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03178734

908398

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Indwelling Foley Catheter

Other group

Description:

These patients will have a traditional foley catheter with attached drainage bag (Indwelling Foley Catheter).

Treatment:

Device: Foley Catheter vs Self-Contained Valved Catheter

Self-Contained Valved Catheter

Other group

Description:

These patients will have a BARD Flip Flo Catheter Valve attached to the original foley catheter (Self-Contained Valved Catheter).

Treatment:

Device: Foley Catheter vs Self-Contained Valved Catheter