Foley Catheter vs a Self-contained Valved Urinary Catheter

Not Applicable

Completed

• Conditions: Catheter-Related Infections; Urinary Tract Infections; Urogynecologic Surgery
• Interventions: Device: Foley Catheter vs Self-Contained Valved Catheter

• Registration Number: NCT03178734
• Lead Sponsor: charbel salamon

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 Timeline

• Study Start: 2016-07-22
• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-07
• Primary Completion: 2019-06-14
• Study Completion: 2019-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-26
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indwelling Foley Catheter	Foley Catheter vs Self-Contained Valved Catheter	These patients will have a traditional foley catheter with attached drainage bag (Indwelling Foley Catheter).
Self-Contained Valved Catheter	Foley Catheter vs Self-Contained Valved Catheter	These patients will have a BARD Flip Flo Catheter Valve attached to the original foley catheter (Self-Contained Valved Catheter).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Atlantic Urogynecology Associates; 🇺🇸 Morristown, New Jersey, United States