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

NCT04703413 | Terminated

• 1 other identifier: LOF-0036
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Bladder Voiding Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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? 1. = completely unsatisfied 2. = unsatisfied 3. = neutral 4. = satisfied 5. = completely satisfied

  30 days

Secondary Outcomes (4)

• Reason for dissatisfaction (if any) when practicing IC with study device.

  30 days

• Experience of any problems before, during and after catheterization with investigational device.

  30 days

• Catheter usability (incl. ease of use) when practicing IC with investigational device.

  30 days

• QoL when practicing IC with investigational device.

  30 days

Study Arms (1)

LoFric® OrigoTM or LoFric® SenseTM

EXPERIMENTAL

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

Interventions

LoFric® OrigoTM and LoFric® SenseTM DEVICE

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.

LoFric® OrigoTM or LoFric® SenseTM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wellspect HealthCare: lead

Study Sites (3)

Leitung der Neuro-Urologie Klinik der Urologie und Kinderurologie Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Gemeinschaftspraxis für Urologie

Dierdorf, 56269, Germany

Location

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

Mönchengladbach, 41063, Germany

Location

Study Officials

• Markus Wittebo, M.Sc. Pharm.

  Wellspect HealthCare

  STUDY DIRECTOR

• Ruth Kirschner-Hermanns, Univ.-Prof. Dr. med.

  Universitätsklinikum Bonn, Germany

  PRINCIPAL INVESTIGATOR

• Antje Foresti, Dr. med.

  Zentrum für Kontinenz und Neuro-Urologie, Kliniken Maria Hilf GmbH, Mönchengladbach

  PRINCIPAL INVESTIGATOR

• Alexander Höinghaus, Dr. med.

  Gemeinschaftspraxis für Urologie, Dierdorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: December 17, 2020
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

DE (3)