Status:
TERMINATED
User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process.
Lead Sponsor:
Wellspect HealthCare
Conditions:
Bladder Voiding Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04703413
Start Date
December 17 2020
End Date
April 15 2023
Last Update
April 28 2023
Active Locations (3)
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1
Leitung der Neuro-Urologie Klinik der Urologie und Kinderurologie Universitätsklinikum Bonn
Bonn, Germany, 53127
2
Gemeinschaftspraxis für Urologie
Dierdorf, Germany, 56269
3
Zentrum für Kontinenz und Neuro-Urologie Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen, Mönchengladbach
Mönchengladbach, Germany, 41063