An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization

NCT05626686 | Completed Results

• 1 other identifier: CP352
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the investigation is to investigate the effect of repeated reuse of intermittent urinary catheters and to observe the impact of switch from single use to multiple reuse catheters.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score.

  The Intermittent Self-Catheterization Questionnaire is a validated, self-reported questionnaire which is scored on a 5-point Likert scale and is translated to a value ranging from 0 (strongly disagree) to 4 (strongly agree) with higher values corresponding to greater Health-related Quality of Life. The aggregate scores across domains and the total score are calculated by averaging and multiplying by 25 to achieve a 100-point scale. Change = (Termination score - Baseline score)

  Baseline (day 0) and Termination (day 28).

Secondary Outcomes (1)

• Adverse Events

  28 days

Study Arms (1)

CLINY reusable catheter 28 days

EXPERIMENTAL

The investigation is designed as an open-labelled, single-arm investigation, in which the reuse CLINY catheter will be compared to single use catheters at baseline.

Device: CLINY catheter

Interventions

CLINY catheter DEVICE

Subjects using a single use catheter for bladder management at inclusion. During the study period, subjects will use the reusable CLINY catheter for 28 test-days

CLINY reusable catheter 28 days

Eligibility Criteria

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

You may qualify if:

• ≥18 years of age and has full legal capacity
• Signed informed consent form
• Ability (assessed by the investigator) and willingness to participate in a 4-week study period with at least three catheterizations a day using the investigational test product

You may not qualify if:

• Participation in any other clinical intervention study during this investigation
• Previous participation in this investigation
• Any known allergies towards ingredients in the investigational device
• Antibiotic treatment within 2 weeks prior to the Baseline visit (V1)
• Pregnancy
• 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

Results Point of Contact

• Title: Zenia Størling, Senior Director of Clinical Strategies
• Organization: Coloplast

dkzenst@coloplast.com

+4549111869

Study Officials

• Karin Andersen

  Odense Universitetshospital

  PRINCIPAL INVESTIGATOR

• Nessn Azawi

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

• Brian Kloster

  Ålborg Universitetshospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The investigation is designed as an open-labelled, single-arm investigation including subjects currently using single use catheters.

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: November 25, 2022
• Study Start: August 12, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: April 15, 2024
• Results First Posted: April 15, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)