NCT04703413TerminatedNot Applicable
User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process. An Open, Prospective, Post-market Clinical Follow-up Investigation.
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Wellspect HealthCare
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- Subjects' satisfaction, when practicing IC (insertion/withdrawal) using study device.
Study Overview
Brief Summary
An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •For inclusion in the study, subjects must fulfil all of the following criteria:
- •Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form
- •Aged 18 years and over, both gender
- •Bladder dysfunction, all diagnosis practicing IC at least 2 times daily
- •Using catheters in the sizes available in the investigation (15 cm, CH 12 or 40 cm CH 12/14, Nelaton tip)
- •Experienced users of IC defined as a minimum of 4 weeks on therapy prior investigation start
- •Adults able to read, write and understand information given to them regarding the investigation
Exclusion Criteria
- •Any of the following is regarded as a criterion for exclusion from the study:
- •Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥103 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection.
- •Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters.
- •Involvement in the planning and conduct of the investigation (applies to both Wellspect/site staff).
- •Previous enrolment in the present investigation.
- •Simultaneous participation in another clinical investigation that may impact the primary endpoint.
- •Expected or severe non-compliance to the CIP as judged by the investigator and/or Wellspect.
Arms & Interventions
LoFric® OrigoTM or LoFric® SenseTM
Experimental
Hydrophilic male (LoFric Origo) and female (LoFric Sense) urinary catheters for single use. Target subject population are subjects suffering from bladder voiding dysfunction and are experienced in intermittent catheterization (IC).
Intervention: LoFric® OrigoTM and LoFric® SenseTM (Device)
Outcomes
Primary Outcomes
Subjects' satisfaction, when practicing IC (insertion/withdrawal) using study device.
Time Frame: 30 days
The subject's assessment of satisfaction using a five-level scale in a pPRO (Wellspect Follow-up questionnaire): How satisfied have you been with the catheterization (insertion/withdrawal) when using the investigational device? 1. = completely unsatisfied 2. = unsatisfied 3. = neutral 4. = satisfied 5. = completely satisfied
Secondary Outcomes
- Reason for dissatisfaction (if any) when practicing IC with study device.(30 days)
- Catheter usability (incl. ease of use) when practicing IC with investigational device.(30 days)
- QoL when practicing IC with investigational device.(30 days)
- Experience of any problems before, during and after catheterization with investigational device.(30 days)
Investigators
Study Sites (3)
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