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

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05626686
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 7.6
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Device: CLINY catheter	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: The investigation is designed as an open-labelled, single-arm investigation including subjects currently using single use catheters.The investigation is designed as an open-labelled, single-arm investigation including subjects currently using single use catheters.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization
• Actual Study Start Date: Aug 12, 2022
• Anticipated Primary Completion Date: Mar 30, 2023
• Anticipated Study Completion Date: Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CLINY reusable catheter 28 days 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; 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

Outcome Measures

Primary Outcome Measures

1. Health-related quality of life (HR-QoL) measured by the intermittent self-catheterization questionnaire, (ISC-Q) index score [28 days]

   Subjects will complete the questionnaire at inclusion and termination

Secondary Outcome Measures

1. Adverse events [28 days]

   Number of Adverse Events during the study

Other Outcome Measures

1. Intermittent Catheterization Satisfaction (InCaSa) questionnaire score [28 days]

   Subjects will complete the questionnaire at inclusion and termination

2. Perception questions (evaluated on a 6-point scale) [28 days]

   Subjects will answer questions at termination

3. Total catheter-associated bacterial count (CFU/mL) [28 days]

   Lab assessment on all used catheters during the study

4. Number of bacterial-positive catheter samples [28 days]

   Lab assessment on all used catheters during the study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odense Universitetshospital	Odense		Denmark	5000

Sponsors and Collaborators

• Coloplast A/S

Investigators

• Principal Investigator: Karin Andersen, Odense Universitetshospital
• Principal Investigator: Nessn Azawi, Zealand University Hospital
• Principal Investigator: Brian Kloster, Ålborg Universitetshospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT05626686
• Other Study ID Numbers: CP352
• First Posted: Nov 25, 2022
• Last Update Posted: Jan 17, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Incontinence

Study Results

No Results Posted as of Jan 17, 2023