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

Convatec

Status: Completed

Conditions: Comfort and Performance of Intermittent Catheter

Treatments: Device: Intermittent Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT03387878

CC-925-17-U378

Details and patient eligibility

About

To evaluate the performance of GentleCath Glide™ Intermittent Catheters

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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
• Subjects with known sensitivity to the device components

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Single Arm Study

Other group

Description:

This is a single arm study with no comparator

Treatment:

Device: Intermittent Catheter