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

Coloplast

Status: Completed

Conditions: Urinary Incontinence

Treatments: Device: CLINY catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05626686

CP352

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

CLINY reusable catheter 28 days

Experimental group

Description:

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.

Treatment:

Device: CLINY catheter