A Multi-centre Clinical Investigation to Assess the Performance of GentleCath™ Glide Intermittent Catheters
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Comfort and Performance of Intermittent Catheter
- Sponsor
- ConvaTec Inc.
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Performance/Ease of Use
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
To evaluate the performance of GentleCath Glide™ Intermittent Catheters
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Performance/Ease of Use
Time Frame: 14 Days
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
Ease of Removal
Time Frame: 14 Days
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
Residue Acceptability
Time Frame: 14 Days
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