Clinical Trial of New Intermittent Single-use Catheter

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: Investigational device - newly developed intermittent catheter; Device: Comparator device #1 - SpeediCath Eve; Device: Comparator device #2 - SpeediCath Compact Plus Female

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense Universitetshospital
  • Vejle, Denmark, 7100
    • Sanos Clinic Vejle
  • København Ø
    • Copenhagen, København Ø, Denmark, 2100
      • Rigshopsitalet
  • Nordjylland
    • Gandrup, Nordjylland, Denmark, 9362
      • Sanos Clinic
• France
  • Lille, France
    • Hôpital Saint- Philibert
  • Paris, France, 75020
    • Hopital Tenon
  • Toulouse, France
    • CHU TOULOUSE Rangueil
• United Kingdom
  • Birmingham, United Kingdom
    • Synexus Birmingham
  • Bristol, United Kingdom
    • North Bristol NHS Trust
  • Cambridge, United Kingdom
    • Addenbrookes
  • Liverpool, United Kingdom
    • Synexus Merseyside

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Tested at site visit after 14 days of device home use.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Tested at site visit after 14 days of device home use.
Number of Flow-stops (Catheterisation Profile, Self-catheterisation)	Number of flow-stop episodes derived from a catheterisation profile (self-catheterisation)	Tested at site visit after 14 days of device home use.
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)	Tested at site visit after 14 days of device home use.
Average Residual Volume Post Catheterisation (Bladder Scan)	Average residual volume post catheterisation measured with the BladderScanner (triplicate measurements)	Tested at site visit after 14 days of device home use.
Number of Adverse Events	Number of Adverse events (number)	From Week 0-4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory: Perception Questionnaire, Handling	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	Tested at site visit after 14 days of device home use.
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction	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	Tested at site visit after 14 days of device home use.

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Karin Andersen, MD, Odense Universitetshospital

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2023
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence
• Other Study ID Numbers: CP348

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No