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Completed

NCT Number: NCT01295281

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.

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Key information

Conditions

Catheterization (Clean, Intermittent Urinary Catheterization)

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kirurg och Urologmottagningen, Alingsås lasarett, Alingsås, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LoFric POBE 2.0

Device

To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.

LoFric PVC

Device

To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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).

Sponsors and collaborators

Lead sponsor

Wellspect HealthCare

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 14, 2011
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.