User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process.

Not Applicable

Terminated

• Conditions: Bladder Voiding Dysfunction
• Interventions: Device: LoFric® OrigoTM and LoFric® SenseTM

• Registration Number: NCT04703413
• Lead Sponsor: Wellspect HealthCare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-17
• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-11
• Status Verified: 2023-04
• Primary Completion: 2023-04-15
• Study Completion: 2023-04-15
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LoFric® OrigoTM or LoFric® SenseTM	LoFric® OrigoTM and LoFric® SenseTM	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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.
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)

Trial Locations

Locations (3)

Leitung der Neuro-Urologie Klinik der Urologie und Kinderurologie Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Gemeinschaftspraxis für Urologie; 🇩🇪 Dierdorf, Germany

Zentrum für Kontinenz und Neuro-Urologie Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen, Mönchengladbach; 🇩🇪 Mönchengladbach, Germany