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

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Device: CLINY catheter

• Registration Number: NCT05626686
• Lead Sponsor: Coloplast A/S

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.

Detailed 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.

Study Timeline

• Study Start: 2022-08-12
• Study First Submitted: 2022-08-25
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-25
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2023-10
• Results First Submitted: 2023-10-23
• Results First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Results First Posted: 2024-04-15
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CLINY reusable catheter 28 days	CLINY catheter	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.

Primary Outcome Measures

Name	Time	Method
Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score.	Baseline (day 0) and Termination (day 28).	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)

Secondary Outcome Measures

Name	Time	Method
Adverse Events	28 days	Number of Adverse Events during the study

Trial Locations

Locations (1)

Odense Universitetshospital; 🇩🇰 Odense, Denmark