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

User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process. An Open, Prospective, Post-market Clinical Follow-up Investigation.

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

Study Overview

• Status: Terminated
• Conditions: Bladder Voiding Dysfunction
• Intervention / Treatment: Device: LoFric® OrigoTM and LoFric® SenseTM

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany, 53127
    • Leitung der Neuro-Urologie Klinik der Urologie und Kinderurologie Universitätsklinikum Bonn
  • Dierdorf, Germany, 56269
    • Gemeinschaftspraxis für Urologie
  • Mönchengladbach, Germany, 41063
    • Zentrum für Kontinenz und Neuro-Urologie Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen, Mönchengladbach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LoFric® OrigoTM or 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).	Device: LoFric® 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects' satisfaction, when practicing IC (insertion/withdrawal) using study device.	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?; = completely unsatisfied; = unsatisfied; = neutral; = satisfied; = completely satisfied	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reason for dissatisfaction (if any) when practicing IC with study device.	The proportion of subjects that are unsatisfied/completely unsatisfied and specifying the reason in free text. pPRO (Wellspect questionnaire)	30 days
Experience of any problems before, during and after catheterization with investigational device.	The proportion of subjects that experienced any problems. A yes/no scale, if yes, a specification (free text) is required. pPRO (Wellspect questionnaire)	30 days
Catheter usability (incl. ease of use) when practicing IC with investigational device.	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.	30 days
QoL when practicing IC with investigational device.	ISC-Q total mean score The mean of all subjects' total score of ISC-Q completed at the end of investigation visits.	30 days

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Collaborators: Wellspect HealthCare
• Investigators: Study Director: Markus Wittebo, M.Sc. Pharm., Wellspect HealthCare; Principal Investigator: Ruth Kirschner-Hermanns, Univ.-Prof. Dr. med., Universitätsklinikum Bonn, Germany; Principal Investigator: Alexander Höinghaus, Dr. med., Gemeinschaftspraxis für Urologie, Dierdorf; Principal Investigator: Antje Foresti, Dr. med., Zentrum für Kontinenz und Neuro-Urologie, Kliniken Maria Hilf GmbH, Mönchengladbach

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): April 15, 2023

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LOF-0036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No