N/A
N=39
An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization
Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT05626686 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: 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. — 79.09; 56.66 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CLINY catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
79.09; 56.66 | — |
| SECONDARY Adverse Events |
11 | — |
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.
Eligibility Criteria
Inclusion Criteria
- ≥18 years of age and has full legal capacity
- Signed informed consent form
- Use clean intermittent catheterization to the greatest extent possible (at least three times daily) for at least the last 1 month prior to inclusion
- 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
- Self-catheterize using a single use hydrophilic coated catheter for at least 1 month prior to inclusion
Exclusion Criteria
- Participation in any other clinical intervention study during this investigation
- Previous participation in this investigation
- Any known allergies towards ingredients in the investigational device
- Symptoms of UTI at time of inclusion, as judged by the investigator
- Antibiotic treatment within 2 weeks prior to the Baseline visit (V1)
- Pregnancy
- Breastfeeding
Data sourced from ClinicalTrials.gov (NCT05626686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.