Clinical Trial of New Single-use Compact Intermittent Catheter

NCT05841004 | Completed Results

• 1 other identifier: CP356
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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, \[mL\]

  At Visit 1 and Visit 2

Secondary Outcomes (3)

• Number of Flowstops (Catheterisation Performed by a Healthcare Professional)

  At Visit 1 and Visit 2

• Residual Volume Post Catheterisation

  At Visit 1 and Visit 2

• Number of Adverse Events

  At Visit 1 and Visit 2

Other Outcomes (1)

• Discomfort Measure by VAS (Only in DK)

  At Visit 1 and Visit 2

Study Arms (2)

Investigational device - newly developed intermittent compact 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.

Device: Investigational device; Device: Comparator device

Hollister Infyna Chic

ACTIVE COMPARATOR

The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter.

Device: Investigational device; Device: Comparator device

Interventions

Investigational device 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.

Hollister Infyna Chic; Investigational device - newly developed intermittent compact catheter

Comparator device DEVICE

Hollister Infyna Chic, single-use compact catheter.

Hollister Infyna Chic; Investigational device - newly developed intermittent compact catheter

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 or is able to use a compact catheter assessed by investigator

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 (1)

Odense Universitetshospital

Odense, 5000, Denmark

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: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: controlled crossover study

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: May 3, 2023
• Study Start: June 20, 2023
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: January 23, 2025
• Results First Posted: January 23, 2025

Record last verified: 2024-12

Locations

DK (1)