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Completed

NCT Number: NCT03178734

Foley Catheter vs a Self-contained Valved Urinary Catheter

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.

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Key information

Conditions

Catheter-Related Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urogynecologic Surgery Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atlantic Urogynecology Associates

Morristown, New Jersey, 07960, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of urinary tract infections

    Time frame: Up to 4 weeks after surgery

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

Secondary outcomes

  1. Patient satisfaction

    Time frame: Up to 5 days after surgery

    Foley satisfaction questionnaire will be collected at post-operative voiding trial office visit.

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

    Time frame: Up to 4 weeks after surgery

    Number of days until spontaneous void and number of call for device-related issues.

Sponsors and collaborators

Lead sponsor

charbel salamon

Other

Registry information

Official study title

Foley Catheter vs a Self-contained Valved Urinary Catheter for Patients Who Are Being Discharged Home With a Catheter After Urogynecologic Procedures

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2017
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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