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Clinical Trial of New Single-use Compact Intermittent Catheter

Sponsor
Coloplast A/S (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05841004
Collaborator
(none)
72
Enrollment
2
Arms
7
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Investigational device
  • Device: Comparator device
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
controlled crossover studycontrolled crossover study
Masking:
None (Open Label)
Primary Purpose:
Prevention
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.
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Investigational device - newly developed intermittent compact catheter

Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use.

Device: Investigational device
Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.

Device: Comparator device
Hollister Infyna Chic, single-use compact catheter.
Active Comparator: Hollister Infyna Chic

The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter.

Device: Investigational device
Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.

Device: Comparator device
Hollister Infyna Chic, single-use compact catheter.

Outcome Measures

Primary Outcome Measures

  1. Residual volume at 1st flow-stop (catheterisation performed by HCP) [From June 2023 - October 2023 (Up to 5 months)]

    Measure residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile, [mL]

Secondary Outcome Measures

  1. Number of flowstops (catheterisation performed by a healthcare professional) [From June 2023 - October 2023 (Up to 5 months)]

    Measure number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional), [number].

  2. Resdiual volume post catheterisation [From June 2023 - October 2023 (Up to 5 months)]

    Measure average residual volume post catheterisation (PVR) measured with a bladder scanner (triplicate measurements), [mL],

  3. Number of Adverse events [From June 2023 - October 2023 (Up to 5 months)]

    Count number of Adverse events, [number]

Other Outcome Measures

  1. Discomfort Measure by VAS (Only in DK) [From June 2023 - October 2023 (Up to 5 months)]

    Discomfort at insertion measured using the visual analog scale (VAS) [cm] Discomfort at withdrawal measured using the VAS, [CM] Discomfort during emptying of bladder measured using the VAS, [CM] Discomfort at end of emptying the bladder measured using the VAS, [CM]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Coloplast A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT05841004
Other Study ID Numbers:
  • CP356
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Urinary Incontinence

Study Results

No Results Posted as of May 3, 2023