Clinical Trial of New Single-use Compact Intermittent Catheter

Urinary Incontinence Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05841004
• Other study ID #: CP356
• Status: Completed
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: September 14, 2023

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: September 14, 2023
• Est. primary completion date: September 14, 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 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

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

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

Locations

Country	Name	City	State
Denmark	Odense Universitetshospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Discomfort Measure by VAS (Only in DK)	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]	From June 2023 - October 2023 (Up to 5 months)
Primary	Residual volume at 1st flow-stop (catheterisation performed by HCP)	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]	From June 2023 - October 2023 (Up to 5 months)
Secondary	Number of flowstops (catheterisation performed by a healthcare professional)	Measure number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional), [number].	From June 2023 - October 2023 (Up to 5 months)
Secondary	Resdiual volume post catheterisation	Measure average residual volume post catheterisation (PVR) measured with a bladder scanner (triplicate measurements), [mL],	From June 2023 - October 2023 (Up to 5 months)
Secondary	Number of Adverse events	Count number of Adverse events, [number]	From June 2023 - October 2023 (Up to 5 months)