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

Sponsor
Dentsply International (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04703413
Collaborator
Wellspect HealthCare (Industry)
70
2
1
30.4
35
1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: LoFric® OrigoTM and LoFric® SenseTM
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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.
Actual Study Start Date :
Dec 17, 2020
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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? = completely unsatisfied = unsatisfied = neutral = satisfied = completely satisfied

Secondary Outcome Measures

  1. 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)

  2. 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)

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Leitung der Neuro-Urologie Klinik der Urologie und Kinderurologie Universitätsklinikum Bonn Bonn Germany 53127
2 Zentrum für Kontinenz und Neuro-Urologie Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen, Mönchengladbach Mönchengladbach Germany 41063

Sponsors and Collaborators

  • Dentsply International
  • 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: Albert Kaufmann, Dr. med., Zentrum für Kontinenz und Neuro-Urologie, Kliniken Maria Hilf GmbH, Mönchengladbach

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dentsply International
ClinicalTrials.gov Identifier:
NCT04703413
Other Study ID Numbers:
  • LOF-0036
First Posted:
Jan 11, 2021
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
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

Study Results

No Results Posted as of Aug 18, 2022