CompletedNot Applicable

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

Denmark40 participantsStarted 2022-08-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

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

Timeframe: Baseline (day 0) and Termination (day 28).

Trial details

NCT IDNCT05626686

SponsorColoplast A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-30

Results submitted2023-10-23

View on ClinicalTrials.gov More Urinary Incontinence trials