Clinical Trial of New Intermittent Single-use Catheter

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Device: Investigational device - newly developed intermittent catheter; Device: Comparator device #1 - SpeediCath Eve; Device: Comparator device #2 - SpeediCath Compact Plus Female

• Registration Number: NCT05814211
• Lead Sponsor: Coloplast A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-14
• Study Start: 2023-08-04
• Primary Completion: 2023-11-29
• Study Completion: 2023-11-29
• Results First Submitted: 2024-09-11
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Results First Posted: 2025-02-20
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Investigational device - newly developed intermittent catheter	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.
Comparator device (#1 OR #2)	Comparator device #1 - SpeediCath Eve	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.
Comparator device (#1 OR #2)	Comparator device #2 - SpeediCath Compact Plus Female	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.

Primary Outcome Measures

Name	Time	Method
Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)	Tested at site visit after 14 days of device home use.	Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (catheterisation performed by a healthcare professional)

Secondary Outcome Measures

Name	Time	Method
Number of Flow-stops (Catheterisation Profile, Catheterisation Performed by HCP)	Tested at site visit after 14 days of device home use.	Number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional)
Number of Flow-stops (Catheterisation Profile, Self-catheterisation)	Tested at site visit after 14 days of device home use.	Number of flow-stop episodes derived from a catheterisation profile (self-catheterisation)
Residual Volume at 1st Flow-stop	Tested at site visit after 14 days of device home use.	Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (self-catheterisation)
Average Residual Volume Post Catheterisation (Bladder Scan)	Tested at site visit after 14 days of device home use.	Average residual volume post catheterisation measured with the BladderScanner (triplicate measurements)
Number of Adverse Events	From Week 0-4	Number of Adverse events (number)

Trial Locations

Locations (11)

Rigshopsitalet; 🇩🇰 Copenhagen, København Ø, Denmark

Hôpital Tenon; 🇫🇷 Paris, France

Sanos Clinic Vejle; 🇩🇰 Vejle, Denmark

Addenbrookes; 🇬🇧 Cambridge, United Kingdom

Hôpital Saint- Philibert; 🇫🇷 Lille, France

Odense Universitetshospital; 🇩🇰 Odense, Denmark

Synexus Birmingham; 🇬🇧 Birmingham, United Kingdom

CHU Toulouse Rangueil; 🇫🇷 Toulouse, France

North Bristol NHS Trust; 🇬🇧 Bristol, United Kingdom

Synexus Merseyside; 🇬🇧 Liverpool, United Kingdom

Sanos Clinic; 🇩🇰 Gandrup, Nordjylland, Denmark