Clinical trial NCT04703413: User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process.
Official title: User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process. An Open, Prospective, Post-market Clinical Follow-up Investigation.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bladder Voiding Dysfunction
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.


Eligibility criteria: 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.

Primary outcomes:
measure: Subjects' satisfaction, when practicing IC (insertion/withdrawal) using study device.
timeFrame: 30 days
Secondary outcomes:
measure: Reason for dissatisfaction (if any) when practicing IC with study device.
timeFrame: 30 days
measure: Experience of any problems before, during and after catheterization with investigational device.
timeFrame: 30 days
measure: Catheter usability (incl. ease of use) when practicing IC with investigational device.
timeFrame: 30 days
measure: QoL when practicing IC with investigational device.
timeFrame: 30 days
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Leitung der Neuro-Urologie Klinik der Urologie und Kinderurologie Universitätsklinikum Bonn
city: Dierdorf
country: Germany
facility: Gemeinschaftspraxis für Urologie
city: Mönchengladbach
country: Germany
facility: Zentrum für Kontinenz und Neuro-Urologie Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen, Mönchengladbach
Study officials:
affiliation: Wellspect HealthCare
name: Markus Wittebo, M.Sc. Pharm.
role: STUDY_DIRECTOR
affiliation: Universitätsklinikum Bonn, Germany
name: Ruth Kirschner-Hermanns, Univ.-Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zentrum für Kontinenz und Neuro-Urologie, Kliniken Maria Hilf GmbH, Mönchengladbach
name: Antje Foresti, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gemeinschaftspraxis für Urologie, Dierdorf
name: Alexander Höinghaus, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: