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Quality of Life Intermittent Catheter Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01523743
First received: January 9, 2012
Last updated: August 23, 2016
Last verified: August 2016
Results First Received: August 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Neurogenic Bladder Dysfunction Nos
Interventions: Device: SpeediCath Compact
Device: Standard care

  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
No text entered.

Reporting Groups
  Description
First Compact Catheter, Then Standard Care First period: Compact intermittent catheter from Coloplast. Second period: Standard Care: Coated intermittent catheter normally used by subject
First Standard Care; Then Compact Catheter First period: Standard Care: Coated intermittent catheter normally used by subject Second period: Compact catheter: Compact intermittent catheter from Coloplast

Participant Flow for 2 periods

Period 1:   Period 1
    First Compact Catheter, Then Standard Care   First Standard Care; Then Compact Catheter
STARTED   63   62 
COMPLETED   53   60 
NOT COMPLETED   10   2 
Adverse Event                1                0 
Withdrawal by Subject                6                2 
Lost to Follow-up                1                0 
Lack of Efficacy                1                0 
Felt unable to empty bladder                1                0 

Period 2:   Period 2
    First Compact Catheter, Then Standard Care   First Standard Care; Then Compact Catheter
STARTED   53   60 
COMPLETED   52   58 
NOT COMPLETED   1   2 
Withdrawal by Subject                0                2 
Adverse Event                1                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.
The ITT population consistsed of 118 subjects.

Reporting Groups
  Description
All Study Participants

125 subjects were randomized in this study, however 7 subjects discontinued only providing baseline data and were therefore excluded from the ITT population as they did not contribute with any endpoint data.

The baseline and analysis data are based on the ITT population.


Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 118 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.8  (15.5) 
Gender 
[Units: Participants]
 
Female   15 
Male   103 
Region of Enrollment 
[Units: Participants]
 
France   40 
Denmark   27 
Norway   5 
Germany   18 
Sweden   28 


  Outcome Measures

1.  Primary:   Quality of Life (0-100 Point)   [ Time Frame: 6 weeks ]


  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
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  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: Pref. Emmanuel Chartier-kastler
Organization: Hopital Raymond poincare
phone: +33 1 42 17 71 29
e-mail: emmanuel.chartier-kastler@psl.aphp.fr



Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01523743     History of Changes
Other Study ID Numbers: CP220
Study First Received: January 9, 2012
Results First Received: August 6, 2013
Last Updated: August 23, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
Denmark: Ethics Committee
Norway: Ethics Committee
Sweden: Regional Ethical Review Board