Foley Catheter vs a Self-contained Valved Urinary Catheter

NCT03178734 | Completed DMC FDA Device

• 1 other identifier: 908398
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter-Related Infections; Urinary Tract Infections; Urogynecologic Surgery

Outcome Measures

Primary Outcomes (1)

• Number of urinary tract infections

  Number of urine cultures positive for infection (taken at voiding trial visit and post-operative visit).

  Up to 4 weeks after surgery

Secondary Outcomes (2)

• Patient satisfaction

  Up to 5 days after surgery

• Number of days until spontaneous void/Number of calls for device-related issues

  Up to 4 weeks after surgery

Study Arms (2)

Indwelling Foley Catheter

OTHER

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

Device: Foley Catheter vs Self-Contained Valved Catheter

Self-Contained Valved Catheter

OTHER

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

Device: Foley Catheter vs Self-Contained Valved Catheter

Interventions

Foley Catheter vs Self-Contained Valved Catheter DEVICE

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.

Indwelling Foley Catheter; Self-Contained Valved Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter.

You may not qualify if:

• Intra-operative bladder injury during index surgery
• Intra-operative complication requiring continuous bladder drainage
• Dementia / altered cognitive function

Sponsors & Collaborators

• charbel salamon: lead

Study Sites (1)

Atlantic Urogynecology Associates

Morristown, New Jersey, 07960, United States

Location

Related Publications (1)

• Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.

  PMID: 34184246 DERIVED

MeSH Terms

Conditions

Catheter-Related Infections; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Charbel G Salamon, MD, MS

  Atlantic Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Charbel Salamon, MD, MS, FACOG

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: June 7, 2017
• Study Start: July 22, 2016
• Primary Completion: June 14, 2019
• Study Completion: June 30, 2019
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)