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Completed

NCT Number: NCT03628833

Incontinence Management System ICU Field Evaluation

The objective of this Field Evaluation is to assess usage and satisfaction associated with the Hill-Rom Incontinence Management System.

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Key information

Conditions

Urinary Incontinence Digestive System Diseases Fecal Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph Hospital

Lexington, Kentucky, 40504, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with urinary, fecal, or dual incontinence who are ≥ 18 years old
  • The patient, or the patient's legal authorized representative (LAR), is willing and able to provide written informed consent

Exclusion criteria

  • Patients that are considered to be near death or require palliative care

Treatment and study plan

Incontinence Management System

Device

Incontinence detection device

Primary outcomes

  1. Staff satisfaction surveys on product performance

    Time frame: Through study completion, an average of 4 months

    Following product use, staff can complete an optional, Likert scale survey

Secondary outcomes

  1. Patient exposure time following an incontinence event

    Time frame: Through study completion, an average of 4 months

Sponsors and collaborators

Lead sponsor

Hill-Rom

Industry

Registry information

Official study title

Hill-Rom Incontinence Management System ICU Field Evaluation

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2018
Registry last updated
Jan 11, 2019

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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