Evaluation of a New Catheter Material for Intermittent Catheterization

Catheterization (Clean, Intermittent Urinary Catheterization) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295281
• Other study ID #: LOF-0018
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: May 2011

Study information

• Verified date: November 2021
• Source: Wellspect HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheterization (Clean, Intermittent Urinary Catheterization)

Intervention

Device:
• LoFric POBE 2.0
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
• LoFric PVC
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.

Locations

Country	Name	City	State
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	Urologmottagningen Uddevalla sjukhus	Uddevalla

Sponsors (1)

Lead Sponsor	Collaborator
Wellspect HealthCare

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Discomfort	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	Perception of Pain	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
Secondary	Perception of Burning Sensation	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
Secondary	Presence of Bleeding	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
Secondary	Perception of "Other Discomfort"	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
Secondary	Perception of Stiffness/ Rigidity	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
Secondary	Perception of Catheter Eyes	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
Secondary	Perception of Catheter Adherence	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
Secondary	Perception of Catheter Tip	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
Secondary	Perception of Slipperiness	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
Secondary	Perception of Smoothness	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
Secondary	Perception of Resistance	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
Secondary	Perception of Discomfort Due to Other Causes	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