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NCT05626686
An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization
Conditions: Urinary Incontinence
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 40
Sponsor: Coloplast A/S
Location: Denmark
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 capacitySigned informed consent formUse clean intermittent catheterization to the greatest extent possible (at least three times daily) for at least the last 1 month prior to inclusionAbility (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 productSelf-catheterize using a single use hydrophilic coated catheter for at least 1 month prior to inclusionExclusion Criteria:Participation in any other clinical intervention study during this investigationPrevious participation in this investigationAny known allergies towards ingredients in the investigational deviceSymptoms of UTI at time of inclusion, as judged by the investigatorAntibiotic treatment within 2 weeks prior to the Baseline visit (V1)PregnancyBreastfeeding
Source: ClinicalTrials.gov (NCT05626686). StuddyBuddy aggregates publicly available trial information.