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
Results First Received: November 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Catheterization (Clean, Intermittent Urinary Catheterization)
Interventions: Device: LoFric POBE 2.0
Device: LoFric PVC

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

107 subjects were enrolled in the study but 105 started treatment, i.e. two subjects dropped out before start of treatment. Both these subjects missed to fulfil all inclusion criteria.

53 subjects started using LoFric Polyolefin Based Elastomer (POBE) 2.0 and 52 subjects started using LoFric Polyvinyl Chloride (PVC).


Reporting Groups
  Description
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

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.

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.

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.


Participant Flow for 2 periods

Period 1:   First Intervention (7 Days)
    LoFric POBE 2.0 - PVC     LoFric PVC - POBE 2.0  
STARTED     53     52  
COMPLETED     53     51  
NOT COMPLETED     0     1  
Death                 0                 1  

Period 2:   Second Intervention (7days)
    LoFric POBE 2.0 - PVC     LoFric PVC - POBE 2.0  
STARTED     53     51  
COMPLETED     53     51  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

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.

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.

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.

Total Total of all reporting groups

Baseline Measures
    LoFric POBE 2.0 - PVC     LoFric PVC - POBE 2.0     Total  
Number of Participants  
[units: participants]
  53     52     105  
Age  
[units: years]
Mean ± Standard Deviation
  71  ± 10     72  ± 10     72  ± 10  
Gender  
[units: participants]
     
Female     0     0     0  
Male     53     52     105  
Region of Enrollment  
[units: participants]
     
Sweden     53     52     105  



  Outcome Measures

1.  Primary:   Number of Participants With Discomfort   [ Time Frame: At 7 and 14 days after randomization, respectively ]

2.  Secondary:   Perception of Pain   [ Time Frame: At 7 and 14 days after randomization, respectively ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Perception of Burning Sensation   [ Time Frame: At 7 and 14 days after randomization, respectively ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Presence of Bleeding   [ Time Frame: At 7 and 14 days after randomization, respectively ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Perception of “Other Discomfort”   [ Time Frame: At 7 and 14 days after randomization, respectively ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Perception of Stiffness/ Rigidity   [ Time Frame: At 7 and 14 days after randomization, respectively ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Perception of Catheter Eyes   [ Time Frame: At 7 and 14 days after randomization, respectively ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Perception of Catheter Adherence   [ Time Frame: At 7 and 14 days after randomization, respectively ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Perception of Catheter Tip   [ Time Frame: At 7 and 14 days after randomization, respectively ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Perception of Slipperiness   [ Time Frame: At 7 and 14 days after randomization, respectively ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Perception of Smoothness   [ Time Frame: At 7 and 14 days after randomization, respectively ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Perception of Resistance   [ Time Frame: At 7 and 14 days after randomization, respectively ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Perception of Discomfort Due to Other Causes   [ Time Frame: At 7 and 14 days after randomization, respectively ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dikran Shamoun
Organization: Wellspect HealthCare
phone: +46313764275
e-mail: dikran.shamoun@wellspect.com


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