Clinical Trial of New Intermittent Single-use Catheter

NCT ID: NCT05814211

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-04
• Study Completion Date: 2023-11-29

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Investigational device - newly developed intermittent catheter

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

Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period.

Group Type: EXPERIMENTAL

Investigational device - newly developed intermittent catheter

Intervention Type: 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.

Comparator device (#1 OR #2)

SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked Coloplast products.

Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period.

Group Type: ACTIVE_COMPARATOR

Comparator device #1 - SpeediCath Eve

Intervention Type: DEVICE

During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one.

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

Comparator device #2 - SpeediCath Compact Plus Female

Intervention Type: DEVICE

During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one.

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

Interventions

Investigational device - newly developed intermittent catheter

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

Intervention Type: DEVICE

Comparator device #1 - SpeediCath Eve

During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one.

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

Intervention Type: DEVICE

Comparator device #2 - SpeediCath Compact Plus Female

During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one.

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karin Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Odense Universitetshospital

Locations

Rigshopsitalet

Copenhagen, København Ø, Denmark

Sanos Clinic

Gandrup, North Denmark, Denmark

Odense Universitetshospital

Odense, , Denmark

Sanos Clinic Vejle

Vejle, , Denmark

Hôpital Saint- Philibert

Lille, , France

Hôpital Tenon

Paris, , France

CHU Toulouse Rangueil

Toulouse, , France

Synexus Birmingham

Birmingham, , United Kingdom

North Bristol NHS Trust

Bristol, , United Kingdom

Addenbrookes

Cambridge, , United Kingdom

Synexus Merseyside

Liverpool, , United Kingdom

Countries

Denmark; France; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP348

Identifier Type: -

Identifier Source: org_study_id