Clinical Trial of New Intermittent Single-use Catheter

Coloplast

Status: Completed

Conditions: Urinary Incontinence

Treatments: Device: Comparator device #2 - SpeediCath Compact Plus Female; Device: Investigational device - newly developed intermittent catheter; Device: Comparator device #1 - SpeediCath Eve

Study type: Interventional

Funder types: Industry

Identifiers

NCT05814211

CP348

Details and patient eligibility

About

A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home. Visits 0 and 1 can be performed on the same day. For visit 2 and 3, 2 catheterisations will be performed in a hospital setting (one HCP catheterisation and one self-catheterisation) for bladder emptying and user experience assessments. Visit 1 and 2 are followed by a home-use test period, followed by visit 3 which terminates the study.

Enrollment: 82 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is Female
• Is at least 18 years of age and has full legal capacity
• Has signed an informed consent form
• Has used clean intermittent self-catheterisation (CISC) (CH12 or CH14) for at least one month up to inclusion
• Is using intermittent self-catheterisation for a minimum of 3 times per day for bladder emptying
• Has used a compact catheter 50% of the time (or more) for the last two weeks prior to entering the study
• Has the ability (assessed by investigator) and willingness to follow study procedures

Exclusion criteria

• Is participating in any other clinical study during this investigation
• Has previously participated in this study
• Has symptoms of urinary tract infection at time of inclusion, as judged by the investigator (if the patient recovers within the recruitment period, a second inclusion is allowed, under a different subject id)
• Is an individual with a history of - suspected to be - or showing signs of producing an excessive amount of mucus or large/clustered sediments or debris
• Has any known allergies towards ingredients in the investigational device
• Is pregnant
• Is breastfeeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Investigational device - newly developed intermittent catheter

Experimental group

Description:

Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period.

Treatment:

Device: Investigational device - newly developed intermittent catheter

Comparator device (#1 OR #2)

Active Comparator group

Description:

SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked Coloplast products. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period.

Treatment:

Device: Comparator device #1 - SpeediCath Eve

Device: Comparator device #2 - SpeediCath Compact Plus Female