Clinical trial NCT05841004: Clinical Trial of New Single-use Compact Intermittent Catheter
Official title: A Randomized, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter vs. Infyna Chic in a Pop-ulation 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: 2023-05-03
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: controlled crossover study
Primary purpose: PREVENTION

Brief summary: The study is a randomised, single-blinded, controlled crossover study. The total study duration for the individual subject will be between two days - two weeks, consisting of three site visits. Visits 0 and 1 can be performed on the same day. Visit 2 can be performed the day after visit 1. For visit 1 and 2, catheterizations will be performed in a hospital setting by a health care professional for bladder emptying assessment and collection of urine samples for haematuria assessment. A sub-group of subjects (all enrolled subjects at DK sites) will be asked to conduct a self-catheterization at visit 2 after hcp catheterization and evaluate discomfort and PVR.

The total study duration for the individual subject will be up to 14 days.


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 or is able to use a compact catheter assessed by investigator

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: At Visit 1 and Visit 2
Secondary outcomes:
measure: Number of Flowstops (Catheterisation Performed by a Healthcare Professional)
timeFrame: At Visit 1 and Visit 2
measure: Residual Volume Post Catheterisation
timeFrame: At Visit 1 and Visit 2
measure: Number of Adverse Events
timeFrame: At Visit 1 and Visit 2
Other outcomes:
measure: Discomfort Measure by VAS (Only in DK)
timeFrame: At Visit 1 and Visit 2
Locations:
city: Odense
country: Denmark
facility: Odense Universitetshospital
Study officials:
affiliation: Odense Universitetshospital
name: Karin Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References: