Clinical trial NCT05814211: Clinical Trial of New Intermittent Single-use Catheter
Official title: A Randomized, Open-labelled, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter in a Population of Adult Female Intermittent Catheter Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)
timeFrame: Tested at site visit after 14 days of device home use.
Secondary outcomes:
measure: Number of Flow-stops (Catheterisation Profile, Catheterisation Performed by HCP)
timeFrame: Tested at site visit after 14 days of device home use.
measure: Number of Flow-stops (Catheterisation Profile, Self-catheterisation)
timeFrame: Tested at site visit after 14 days of device home use.
measure: Residual Volume at 1st Flow-stop
timeFrame: Tested at site visit after 14 days of device home use.
measure: Average Residual Volume Post Catheterisation (Bladder Scan)
timeFrame: Tested at site visit after 14 days of device home use.
measure: Number of Adverse Events
timeFrame: From Week 0-4
Other outcomes:
measure: Exploratory: Perception Questionnaire, Handling
timeFrame: Tested at site visit after 14 days of device home use.
measure: Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction
timeFrame: Tested at site visit after 14 days of device home use.
Locations:
city: Copenhagen
country: Denmark
facility: Rigshopsitalet
state: København Ø
city: Gandrup
country: Denmark
facility: Sanos Clinic
state: Nordjylland
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Vejle
country: Denmark
facility: Sanos Clinic Vejle
city: Lille
country: France
facility: Hôpital Saint- Philibert
city: Paris
country: France
facility: Hôpital Tenon
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Birmingham
country: United Kingdom
facility: Synexus Birmingham
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Cambridge
country: United Kingdom
facility: Addenbrookes
city: Liverpool
country: United Kingdom
facility: Synexus Merseyside
Study officials:
affiliation: Odense Universitetshospital
name: Karin Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References: