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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05626686
• Other study ID #: CP352
• Status: Completed
• Phase: N/A
• Start date: August 12, 2022
• Est. completion date: March 30, 2023

Study information

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

Clinical Trial 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.

Description:

Throughout the investigation, the impact of switch from single use to multiple reuse catheters will be observed and compared with respect to health-related quality of life (HR-QoL), satisfaction, perception, and preference in female and male catheter-users, who use clean intermittent catheterization (CIC) for bladder management.

Furthermore, the investigation intends to identify microbial contamination of reused catheters and compare proportions to a control single use catheter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. =18 years of age and has full legal capacity

2. Signed informed consent form

3. Use clean intermittent catheterization to the greatest extent possible (at least three times daily) for at least the last 1 month prior to inclusion

4. 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

5. Self-catheterize using a single use hydrophilic coated catheter for at least 1 month prior to inclusion

Exclusion Criteria:

1. Participation in any other clinical intervention study during this investigation

2. Previous participation in this investigation

3. Any known allergies towards ingredients in the investigational device

4. Symptoms of UTI at time of inclusion, as judged by the investigator

5. Antibiotic treatment within 2 weeks prior to the Baseline visit (V1)

6. Pregnancy

7. Breastfeeding

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Device:
• CLINY catheter
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

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
Primary	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	Adverse Events	Number of Adverse Events during the study	28 days