Clinical Trial of New Intermittent Single-use Catheter

Urinary Incontinence Clinical Trial

Official title:

A Randomized, Open-labelled, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter in a Population of Adult Female Intermittent Catheter Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05814211
• Other study ID #: CP348
• Status: Completed
• Phase: N/A
• Start date: August 4, 2023
• Est. completion date: November 29, 2023

Study information

• Verified date: November 2023
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Device:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	Rigshopsitalet	Copenhagen	København Ø
Denmark	Sanos Clinic	Gandrup	Nordjylland
Denmark	Odense Universitetshospital	Odense
Denmark	Sanos Clinic Vejle	Vejle
France	Hôpital Saint- Philibert	Lille
France	Hôpital Tenon	Paris
France	CHU Toulouse Rangueil	Toulouse
United Kingdom	Synexus Birmingham	Birmingham
United Kingdom	North Bristol NHS Trust	Bristol
United Kingdom	Addenbrookes	Cambridge
United Kingdom	Synexus Merseyside	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

Denmark,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Perception questionnaire	Perception questions evaluated on a 5-point scale assessed on V2 and V3 (perception questionnaire). Perception questionary based on perception of catheterisations in test period leading up to the visit	Week 2 and 4
Primary	Residual volume at 1st flow-stop (catheterisation performed by HCP)	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)	Week 2 and 4
Secondary	Number of flow-stops (catheterisation profile, catheterisation performed by HCP)	Number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional)	Week 2 and 4
Secondary	Number of flow-stops (catheterisation profile, self-catheterisation)	Number of flow-stop episodes derived from a catheterisation profile (self-catheterisation)	Week 2 and 4
Secondary	Residual volume at 1st flow-stop	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)	Week 2 and 4
Secondary	Average residual volume post catheterisation (bladder scan)	Average residual volume post catheterisation measured with the BladderScanner (triplicate measurements)	Week 2 and 4
Secondary	Number of Adverse events	Number of Adverse events (number)	From Week 0-4