Evaluation of a New Catheter Material for Intermittent Catheterization

November 10, 2021 updated by: Wellspect HealthCare

A Prospective, Randomized, Cross-over Study - Evaluation of a New Catheter Material for Intermittent Catheterization

The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e. clinically non-inferior when using POBE 2.0 compared to PVC.

Secondary objectives are to evaluate the safety and the subject's perception associated with the use of the catheters, assessed by the recording of adverse events and the ease of handling by means of a subjective assessment scale.

Study Overview

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • 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

      • Alingsås, Sweden, 441 33
        • Kirurg och Urologmottagningen, Alingsås lasarett
      • Borås, Sweden, 501 32
        • Urologcentrum
      • Gävle, Sweden, 801 87
        • Kirurg- och urologmottagningen, Gävle Sjukhus
      • Göteborg, Sweden, 417 17
        • Urologmottagningen, Lundby Sjukhus
      • Skövde, Sweden, 541 85
        • Uroterapimottagningen Kärnsjukhuset Skövde
      • Uddevalla, Sweden, 451 80
        • Urologmottagningen Uddevalla sjukhus

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

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
  • Practice intermittent self-catheterization at least 2 times daily
  • Using catheters in the length of 40 cm and size charrière (Ch) 12 or Ch 14
  • Experienced practitioners of intermittent self-catheterization defined as a minimum of three months on therapy
  • Experience of using LoFric catheter within the last 12 months prior to study entry
  • Adults able to read, write and understand information given to them regarding the study

Exclusion Criteria:

  • Ongoing, symptomatic urinary tract infection (UTI) at enrolment as judged by investigator
  • Known urethral stricture at enrolment as judged by investigator
  • Involvement in the planning and/or conduct of the study (applies to both Astra Tech staff or staff at the study site)
  • Previous enrolment or randomisation of treatment in the present study

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: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LoFric POBE 2.0 - PVC
First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
EXPERIMENTAL: LoFric PVC - POBE 2.0
First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Discomfort
Time Frame: At 7 and 14 days after randomization, respectively
The primary objective of this study is to compare the subject's tolerability, with regards to perceived discomfort, when using two different urinary catheters. Perception of discomfort (yes/ no) will be assessed in patient questionnaire for each subject. The frequency of discomfort will be compared between the treatments.
At 7 and 14 days after randomization, respectively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of Pain
Time Frame: At 7 and 14 days after randomization, respectively
To compare subject's tolerability with regards to perceived pain, when using two different urinary catheters; PVC vs. POBE 2.0. 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.
At 7 and 14 days after randomization, respectively
Perception of Burning Sensation
Time Frame: At 7 and 14 days after randomization, respectively
To compare subject's tolerability with regards to perceived burning sensation, when using two different urinary catheters; PVC vs. POBE 2.0. 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.
At 7 and 14 days after randomization, respectively
Presence of Bleeding
Time Frame: At 7 and 14 days after randomization, respectively
To compare subject's tolerability with regards to presence of bleeding, when using two different urinary catheters; PVC vs. POBE 2.0. 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.
At 7 and 14 days after randomization, respectively
Perception of "Other Discomfort"
Time Frame: At 7 and 14 days after randomization, respectively
To compare subject's tolerability with regards to perceived "other discomfort", when using two different urinary catheters; PVC vs. POBE 2.0. 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).
At 7 and 14 days after randomization, respectively
Perception of Stiffness/ Rigidity
Time Frame: At 7 and 14 days after randomization, respectively
To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. 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.
At 7 and 14 days after randomization, respectively
Perception of Catheter Eyes
Time Frame: At 7 and 14 days after randomization, respectively
To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. 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.
At 7 and 14 days after randomization, respectively
Perception of Catheter Adherence
Time Frame: At 7 and 14 days after randomization, respectively
To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. 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.
At 7 and 14 days after randomization, respectively
Perception of Catheter Tip
Time Frame: At 7 and 14 days after randomization, respectively
To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. 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.
At 7 and 14 days after randomization, respectively
Perception of Slipperiness
Time Frame: At 7 and 14 days after randomization, respectively
To evaluate subject perception related to the properties of the catheter's coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. 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.
At 7 and 14 days after randomization, respectively
Perception of Smoothness
Time Frame: At 7 and 14 days after randomization, respectively
To evaluate subject perception related to the properties of the catheter's coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. 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.
At 7 and 14 days after randomization, respectively
Perception of Resistance
Time Frame: At 7 and 14 days after randomization, respectively
To evaluate subject perception related to the properties of the catheter's coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. 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.
At 7 and 14 days after randomization, respectively
Perception of Discomfort Due to Other Causes
Time Frame: At 7 and 14 days after randomization, respectively
To compare subject's tolerability with regards to perceived discomfort due to other causes, when using two different urinary catheters 2.0. Frequency of discomfort due to other causes (yes/ no) will be assessed in patient questionnaire. The frequency of discomfort due to other causes will be compared between the treatments. Discomfort due to other causes 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).
At 7 and 14 days after randomization, respectively

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Birgit Johansson, Urotherapist, Kärnsjukhuset Skövde

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

March 1, 2011

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

January 21, 2011

First Submitted That Met QC Criteria

February 11, 2011

First Posted (ESTIMATE)

February 14, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 10, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • LOF-0018

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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