Evaluation of a New Catheter Material for Intermittent Catheterization

Not Applicable

Completed

• Conditions: Catheterization (Clean, Intermittent Urinary Catheterization)
• Interventions: Device: LoFric POBE 2.0; Device: LoFric PVC

• Registration Number: NCT01295281
• Lead Sponsor: Wellspect HealthCare

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-02-11
• Study First Posted: 2011-02-14
• Study Start: 2011-03
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2013-11-22
• Results First Submitted QC: 2014-01-15
• Results First Posted: 2014-03-03
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LoFric POBE 2.0 - PVC	LoFric PVC	First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC
LoFric POBE 2.0 - PVC	LoFric POBE 2.0	First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC
LoFric PVC - POBE 2.0	LoFric POBE 2.0	First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.
LoFric PVC - POBE 2.0	LoFric PVC	First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Discomfort	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 Outcome Measures

Name	Time	Method
Perception of Pain	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.
Perception of Burning Sensation	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.
Presence of Bleeding	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.
Perception of "Other Discomfort"	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).
Perception of Stiffness/ Rigidity	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.
Perception of Catheter Eyes	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.
Perception of Catheter Adherence	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.
Perception of Catheter Tip	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.
Perception of Slipperiness	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.
Perception of Smoothness	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.
Perception of Resistance	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.
Perception of Discomfort Due to Other Causes	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).

Trial Locations

Locations (6)

Urologmottagningen Uddevalla sjukhus; 🇸🇪 Uddevalla, Sweden

Kirurg och Urologmottagningen, Alingsås lasarett; 🇸🇪 Alingsås, Sweden

Urologcentrum; 🇸🇪 Borås, Sweden

Kirurg- och urologmottagningen, Gävle Sjukhus; 🇸🇪 Gävle, Sweden

Urologmottagningen, Lundby Sjukhus; 🇸🇪 Göteborg, Sweden

Uroterapimottagningen Kärnsjukhuset Skövde; 🇸🇪 Skövde, Sweden