Bladder Voiding Dysfunction
Conditions
Brief summary
An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.
Interventions
DEVICELoFric® OrigoTM and LoFric® SenseTM
The investigational device is either a CE-marked LoFric® OrigoTM , 40 cm, CH12/CH14 or LoFric® SenseTM, 15 cm, CH12. They are all intermittent urinary catheters with a Nelaton tip from a more sustainable manufacturing process. All subjects will use the investigational device for 30 days each.
Sponsors
Wellspect HealthCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For inclusion in the study, subjects must fulfil all of the following criteria: 1. Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form 2. Aged 18 years and over, both gender 3. Bladder dysfunction, all diagnosis practicing IC at least 2 times daily 4. Using catheters in the sizes available in the investigation (15 cm, CH 12 or 40 cm CH 12/14, Nelaton tip) 5. Experienced users of IC defined as a minimum of 4 weeks on therapy prior investigation start 6. 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: 1. 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. 2. Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters. 3. Involvement in the planning and conduct of the investigation (applies to both Wellspect/site staff). 4. Previous enrolment in the present investigation. 5. Simultaneous participation in another clinical investigation that may impact the primary endpoint. 6. Expected or severe non-compliance to the CIP as judged by the investigator and/or Wellspect.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects' satisfaction, when practicing IC (insertion/withdrawal) using study device. | 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
| Measure | Time frame | Description |
|---|---|---|
| Reason for dissatisfaction (if any) when practicing IC with study device. | 30 days | The proportion of subjects that are unsatisfied/completely unsatisfied and specifying the reason in free text. pPRO (Wellspect questionnaire) |
| Experience of any problems before, during and after catheterization with investigational device. | 30 days | The proportion of subjects that experienced any problems. A yes/no scale, if yes, a specification (free text) is required. pPRO (Wellspect questionnaire) |
| Catheter usability (incl. ease of use) when practicing IC with investigational device. | 30 days | The mean of all subject's answers/domain score of ISC-Q (ease of use) completed at the end of investigation visits. pPRO (Wellspect questionnaire) and ISC-Q - domain ease of use. |
| QoL when practicing IC with investigational device. | 30 days | ISC-Q total mean score The mean of all subjects' total score of ISC-Q completed at the end of investigation visits. |
Countries
Germany
Outcome results
None listed