Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization.

December 4, 2018 updated by: Dentsply International

Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization - A Prospective, Blinded, Randomized, Cross-over, Multicenter Study

This is a prospective, double-blinded, randomized, multi-centre, cross-over study. All subjects will use both the study device (test catheter) and the comparator (control catheter) for one week each.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Borås, Sweden, 503 32
        • Urologcentrum Borås
      • Gothenburg, Sweden, 405 45
        • Urologkliniken vid Carlanderska AB
      • Halmstad, Sweden, 302 46
        • Specialistmottagningen i Urologi, Halmstad
      • Karlstad, Sweden, 651 85
        • Urologmottagningen, Centralsjukhuset Karlstad
      • Stockholm, Sweden, 117 94
        • GHP Urologcentrum Stockholm
      • Torsby, Sweden, 685 34
        • Uroterapimottagningen, Sjukhuset Torsby
      • Uppsala, Sweden, 751 85
        • Urologmottagningen, Akademiska sjukhuset
      • Örebro, Sweden, 701 85
        • Urologiska kliniken, Urologmottagningen Universitetssjukhuset Örebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Provision of informed consent.
  • Males, aged 18 years and over.
  • Maintained urethra sensibility as judged by the subject. (Can you feel the catheter during catheterization? Yes.).
  • Practice CIC at least 2 times daily.
  • Using catheters in the size CH 12 or CH 14, Nelaton tip, and able to use catheter length of 40 cm.
  • Experienced users of CIC defined as a minimum of three months on therapy.
  • Adults able to read, write and understand information given to them regarding the study.

Exclusion Criteria:

  • 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 study (applies to both WHC staff and staff at the study site).
  • Previous enrolment or randomisation of treatment in the present study.
  • Simultaneous participation in another clinical study that may impact the primary endpoint.
  • Severe non-compliance to protocol as judged by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Period One
LoFric, hydrophilic urinary catheter for single use. The study device is based on commercially available hydrophilic urinary catheters for intermittent catheterization, but with a different coating process than the comparator. Treatment Period One will last 1 week.
Device: Treatment Period One
LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip
Active Comparator: Treatment Period Two
CE-marked LoFric®, hydrophilic urinary catheter for single use. The comparator product is today commercially available and produced by WHC. Treatment Period Two will last 1 week.
Device: Treatment Period Two
CE-marked LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tolerability of practicing CIC by using two urinary catheters produced with different coating processes measuring change over time by means of subjective assessment scales
Time Frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two
The primary objective of this study is to compare the subjects' tolerability of practising CIC by using two urinary catheters produced with different coating processes by means of subjective assessment scales.
2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tolerability with regards to perceived pain, when using two different urinary catheters; test vs control catheter.
Time Frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
AE/SAE/ADE/SADE reporting/PRO variables. Assessed in patient questionnaire for each subject. A 5 graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.
2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Tolerability with regards to presence of bleeding, when using two different urinary catheters; test vs control catheter
Time Frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
AE/SAE/ADE/SADE reporting /PRO variables. Assessed in patient questionnaire for each subject. A 5 graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.
2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Tolerability with regards to perceived "other discomfort", when using two different urinary catheters; test vs. control catheter
Time Frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
PRO variables. Frequency of "other discomfort" (yes/ no) will be assessed in patient questionnaire. The frequency of "other discomfort" will be compared between the treatments. "Other discomfort" will be further specified using 5 graded scale (as for the other variables on the 5 graded scale the difference between the treatments will be calculated for each subject).
2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Perception of the catheter's slipperiness, smoothness, flexibility, usability, and resistance, when practicing intermittent self-catheterization with urinary catheters; test vs. control catheter
Time Frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
PRO variables. Assessed in patient questionnaire for each subject. A 5 graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.
2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
To evaluate subject satisfaction with catheter; test vs. control catheter.
Time Frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
PRO variables. Assessed in patient questionnaire for each subject. A 5 graded scale will be used to determine the satisfaction. The difference between the treatments will be calculated for each subject.
2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Total number of DD/AE/SAE/ADE/SADE/ USADE.
Time Frame: 2 weeks in total.
Total number of DD/AE/SAE/ADE/SADE/ USADE observed by the study personnel or spontaneously reported from subject will be calculated. The frequency of DD/AE/SAE/ADE/SADE/ USADE will be calculated for each treatment group.
2 weeks in total.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dentsply International

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wellspect HealthCare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 29, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 19, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOF-0034

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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