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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03387878

Enrollment

Registered

2018-01-02

Start date

2017-07-01

Completion date

2018-01-10

Last updated

2022-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comfort and Performance of Intermittent Catheter

Brief summary

To evaluate the performance of GentleCath Glide™ Intermittent Catheters

Interventions

DEVICEIntermittent Catheter

Intermittent urinary catheter for bladder drainage

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Performance/Ease of Use	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	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	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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026