A Multi-centre Clinical Investigation to Assess the Performance of GentleCath™ Glide Intermittent Catheters

To evaluate the performance of GentleCath Glide™ Intermittent Catheters

Study Overview

• Status: Completed
• Conditions: Comfort and Performance of Intermittent Catheter
• Intervention / Treatment: Device: Intermittent Catheter

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Rzeszow, Poland, 35-326
    • Specjalistyczny Gabinet Lekarski

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects of 18 years old and above who require intermittent bladder drainage may be recruited into the study
• Subjects must be willing and able to provide written informed consent
• Subjects may be either inpatients or outpatients but must all be capable of completing a patient diary card to record study data
• Subjects must currently use intermittent catheters and have been using intermittent catheters for the last six months
• Patients who self-catheterise at least three times per day
• Able to attend final assessment visit at day 14

Exclusion Criteria

• Subjects who require intermittent catheterisation to administer irrigation or instillation.
• Subjects who are presently participating in another clinical trial.
• Subjects exhibiting any other medical condition which, according to the investigator, justifies the subject's exclusion from the study
• Subjects with known sensitivity to the device components

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm Study; This is a single arm study with no comparator	Device: Intermittent Catheter; Intermittent urinary catheter for bladder drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance/Ease of Use	Performance and ease of use will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement	14 Days
Ease of Removal	Ease of removal will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement	14 Days
Residue Acceptability	Residue acceptability will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement	14 Days

Collaborators and Investigators

• Sponsor: ConvaTec Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): January 10, 2018
• Study Completion (Actual): January 10, 2018

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CC-925-17-U378

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No