Evaluation of a New Catheter Material for Intermittent Catheterization

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wellspect HealthCare
ClinicalTrials.gov Identifier:
NCT01295281
First received: January 21, 2011
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Catheterization (Clean, Intermittent Urinary Catheterization)
Device: LoFric POBE 2.0
Device: LoFric PVC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Cross-over Study - Evaluation of a New Catheter Material for Intermittent Catheterization

Further study details as provided by Wellspect HealthCare:

Primary Outcome Measures:
  • Number of Participants With Discomfort [ Time Frame: At 7 and 14 days after randomization, respectively ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Perception of Pain [ Time Frame: At 7 and 14 days after randomization, respectively ] [ Designated as safety issue: Yes ]
    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.

  • Perception of Burning Sensation [ Time Frame: At 7 and 14 days after randomization, respectively ] [ Designated as safety issue: Yes ]
    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.

  • Presence of Bleeding [ Time Frame: At 7 and 14 days after randomization, respectively ] [ Designated as safety issue: Yes ]
    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.

  • Perception of "Other Discomfort" [ Time Frame: At 7 and 14 days after randomization, respectively ] [ Designated as safety issue: Yes ]
    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).

  • Perception of Stiffness/ Rigidity [ Time Frame: At 7 and 14 days after randomization, respectively ] [ Designated as safety issue: No ]
    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.

  • Perception of Catheter Eyes [ Time Frame: At 7 and 14 days after randomization, respectively ] [ Designated as safety issue: No ]
    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.

  • Perception of Catheter Adherence [ Time Frame: At 7 and 14 days after randomization, respectively ] [ Designated as safety issue: No ]
    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.

  • Perception of Catheter Tip [ Time Frame: At 7 and 14 days after randomization, respectively ] [ Designated as safety issue: No ]
    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.

  • Perception of Slipperiness [ Time Frame: At 7 and 14 days after randomization, respectively ] [ Designated as safety issue: No ]
    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.

  • Perception of Smoothness [ Time Frame: At 7 and 14 days after randomization, respectively ] [ Designated as safety issue: No ]
    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.

  • Perception of Resistance [ Time Frame: At 7 and 14 days after randomization, respectively ] [ Designated as safety issue: No ]
    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.

  • Perception of Discomfort Due to Other Causes [ Time Frame: At 7 and 14 days after randomization, respectively ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 107
Study Start Date: March 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: LoFric POBE 2.0
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
Device: LoFric PVC
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.
Device: LoFric POBE 2.0
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
Device: LoFric PVC
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295281

Locations
Sweden
Kirurg och Urologmottagningen, Alingsås lasarett
Alingsås, Sweden, 441 33
Urologcentrum
Borås, Sweden, 501 32
Kirurg- och urologmottagningen, Gävle Sjukhus
Gävle, Sweden, 801 87
Urologmottagningen, Lundby Sjukhus
Göteborg, Sweden, 417 17
Uroterapimottagningen Kärnsjukhuset Skövde
Skövde, Sweden, 541 85
Urologmottagningen Uddevalla sjukhus
Uddevalla, Sweden, 451 80
Sponsors and Collaborators
Wellspect HealthCare
Investigators
Principal Investigator: Birgit Johansson, Urotherapist Kärnsjukhuset Skövde
  More Information

No publications provided

Responsible Party: Wellspect HealthCare
ClinicalTrials.gov Identifier: NCT01295281     History of Changes
Other Study ID Numbers: LOF-0018
Study First Received: January 21, 2011
Results First Received: November 22, 2013
Last Updated: January 15, 2014
Health Authority: Sweden: Regional Ethical Review Board

ClinicalTrials.gov processed this record on July 20, 2014