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

Comfort and Performance of Intermittent Catheter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387878
• Other study ID #: CC-925-17-U378
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: January 10, 2018

Study information

• Verified date: December 2022
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the performance of GentleCath Glide™ Intermittent Catheters

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Comfort and Performance of Intermittent Catheter

Intervention

Device:
• Intermittent Catheter
Intermittent urinary catheter for bladder drainage

Locations

Country	Name	City	State
Poland	Specjalistyczny Gabinet Lekarski	Rzeszow

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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