Clinical Trial of New Single-use Compact Intermittent Catheter

Last updated: December 4, 2024
Sponsor: Coloplast A/S
Overall Status: Completed

Phase

N/A

Condition

Enuresis

Urinary Incontinence

Treatment

Investigational device

Comparator device

Clinical Study ID

NCT05841004
CP356
  • Ages > 18
  • Female

Study 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

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 leastone month up to inclusion

  • Is using intermittent self-catheterisation for a minimum of 3 times per day forbladder emptying

  • Has used a compact catheter 50% of the time (or more) for the last two weeks priorto entering the study

  • Has the ability (assessed by investigator) and willingness to follow studyprocedures or is able to use a compact catheter assessed by investigator

Exclusion

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 theinvestigator (if the patient recovers within the recruitment period, a secondinclusion is allowed, under a different subject id)

  • Is an individual with a history of - suspected to be - or showing signs of producingan excessive amount of mucus or large/clustered sediments or debris

  • Has any known allergies towards ingredients in the investigational device

  • Is pregnant

  • Is breastfeeding

Study Design

Total Participants: 73
Treatment Group(s): 2
Primary Treatment: Investigational device
Phase:
Study Start date:
June 20, 2023
Estimated Completion Date:
September 14, 2023

Connect with a study center

  • Odense Universitetshospital

    Odense, 5000
    Denmark

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.