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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-12

Study Completion Date

2023-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter

NCT05224544

Urinary Incontinence

COMPLETED NA

Evaluation of Residual Urine After Intermittent Catheterisation

NCT00324233

Healthy

COMPLETED NA

Efficacy of Conservative Treatments for Urinary Incontinence in Women

NCT05977231

Urinary Incontinence

RECRUITING

Comparison of Two Intermittent Urinary Catheters

NCT01284361

Urinary Retention

COMPLETED NA

Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence

NCT03942549

Stress Urinary Incontinence

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

CLINY catheter

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No