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Investigation of Non-CE Marked Intermittent Catheters.

Sponsor
Coloplast A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT04543136
Collaborator
(none)
16
Enrollment
1
Location
3
Arms
3.9
Actual Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter

Condition or Disease Intervention/Treatment Phase
  • Device: SpeediCath® Standard male
  • Device: New intermittent Variant 1 catheter for males
  • Device: New intermittent Variant 2 catheter for males
 N/A

Detailed Description

The CP323 study investigated a novel non-CE marked intermittent catheter, designed in two different variants, Variant 1 and Variant 2, respectively, and was conducted in Denmark. The study was a randomized, single blinded, cross-over investigation, comparing the two new variant catheters with a comparator catheter in 15 male IC users.

For each participant, the study thus contains three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 15 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Exploratory Investigation on Performance and Safety of Newly Developed Intermittent Catheters in Male Users of Intermittent Catheters
Actual Study Start Date :
Oct 3, 2020
Actual Primary Completion Date :
Jan 31, 2021
Actual Study Completion Date :
Jan 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intermittent catheter; SpeediCath® Standard male

Participants underwent two catheterizations with standard of care intermittent catheter: The first was performed by a trained nurse, the second by the participant later the same day.

Device: SpeediCath® Standard male
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male.
Experimental: New intermittent catheter Variant 1 for males

Participants underwent two catheterizations with the new intermittent catheter Variant 1 for males: The first was performed by a trained nurse, the second by the participant later the same day.

Device: New intermittent Variant 1 catheter for males
Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.
Experimental: New intermittent catheter Variant 2 for males

Participants underwent two catheterizations with the new intermittent catheter Variant 2 for males: The first was performed by a trained nurse, the second by the participant later the same day.

Device: New intermittent Variant 2 catheter for males
Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.

Outcome Measures

Primary Outcome Measures

  1. Residual urine at 1st clogging [Immediately after procedure/catherterization]

    Volume of residual urine at 1st clogging assessed by a pressure sensor with time-logged weighing.

Secondary Outcome Measures

  1. Residual urine post catheterisation [Immediately after procedure/catherterization]

    Volume of residual urine post catheterization assessed by ultrasound scan

  2. Discomfort [Immediately after procedure/catherterization]

    Discomfort measured using Visual Analogue Scale (VAS). A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain/discomfort is a straight line of 10 cm with one end meaning no pain/discomfort and the other end meaning the worst pain/discomfort imaginable. The subject marks a point on the line that matches the amount of pain/discomfort he or she feels.

  3. Adverse events [Up to 42 days]

    Number of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male

  • Minimum 18 years of age and with full legal capacity

  • Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months

  • Ability to self-catheterize

  • Written informed consent, signed letter of authority and signed secrecy agreement given

Exclusion Criteria:

  • Participation in any other clinical study during this investigation

  • Symptoms of urinary tract infection as judged by the investigator

  • Any know allergies towards ingredients in the products

  • Relevant medical history that would prevent the subject from participation in the investigation (investigators judgement)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet Copenhagen Denmark

Sponsors and Collaborators

  • Coloplast A/S

Investigators

  • Principal Investigator: Per Bagi, MD, Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT04543136
Other Study ID Numbers:
  • CP323
First Posted:
Sep 9, 2020
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Urinary Retention

Study Results

No Results Posted as of Aug 11, 2022