Clinical Trial of New Intermittent Single-use Catheter

NCT05814211 | Completed Results

• 1 other identifier: CP348
• Study Type: interventional
• Target: 82
• Locations: 3 countries
• Sites: 11

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of Flow-stops (Catheterisation Profile, Catheterisation Performed by HCP)

  Tested at site visit after 14 days of device home use.

• Number of Flow-stops (Catheterisation Profile, Self-catheterisation)

  Tested at site visit after 14 days of device home use.

• Residual Volume at 1st Flow-stop

  Tested at site visit after 14 days of device home use.

• Average Residual Volume Post Catheterisation (Bladder Scan)

  Tested at site visit after 14 days of device home use.

• Number of Adverse Events

  From Week 0-4

Other Outcomes (2)

• Exploratory: Perception Questionnaire, Handling

  Tested at site visit after 14 days of device home use.

• Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction

  Tested at site visit after 14 days of device home use.

Study Arms (2)

Investigational device - newly developed intermittent catheter

EXPERIMENTAL

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

Comparator device (#1 OR #2)

ACTIVE COMPARATOR

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; Device: Comparator device #2 - SpeediCath Compact Plus Female

Interventions

Investigational device - newly developed intermittent catheter 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.

Investigational device - newly developed intermittent catheter

Comparator device #1 - SpeediCath Eve 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 (#1 OR #2)

Comparator device #2 - SpeediCath Compact Plus Female 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 (#1 OR #2)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is Female
• Is at least 18 years of age and has full legal capacity
• Has signed an informed consent form
• 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

You may not qualify if:

• Is participating in any other clinical study during this investigation
• Has previously participated in this study
• 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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (11)

Rigshopsitalet

Copenhagen, København Ø, 2100, Denmark

Location

Sanos Clinic

Gandrup, North Denmark, 9362, Denmark

Location

Odense Universitetshospital

Odense, 5000, Denmark

Location

Sanos Clinic Vejle

Vejle, 7100, Denmark

Location

Hôpital Saint- Philibert

Lille, France

Location

Hôpital Tenon

Paris, 75020, France

Location

CHU Toulouse Rangueil

Toulouse, France

Location

Synexus Birmingham

Birmingham, United Kingdom

Location

North Bristol NHS Trust

Bristol, United Kingdom

Location

Addenbrookes

Cambridge, United Kingdom

Location

Synexus Merseyside

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The natural distribution of residual volume at 1st flow-stop values skews positively. This carries a high risk of influence by random occurrences of extreme values. These can occur without systematic relation to product or subject and can obscure interpretability of the analysis. To counter this effect, post hoc responder analyses were included, testing the benefit of treatment through the proportion of individuals who achieve the desired outcome, i.e., complete and effective bladder drainage.

Results Point of Contact

• Title: Christian Riis Forman, Medical writer
• Organization: Coloplast A/S

dkcrif@coloplast.com

49111756

Study Officials

• Karin Andersen, MD

  Odense Universitetshospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 14, 2023
• Study Start: August 4, 2023
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: February 20, 2025
• Results First Posted: February 20, 2025

Record last verified: 2025-01

Locations

DK (4); FR (3); GB (4)