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Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00937833
First received: July 10, 2009
Last updated: November 5, 2014
Last verified: November 2014
Results First Received: October 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Urinary Incontinence
Prostate Cancer
Intervention: Device: Surgisis Male Sling

  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
Urethrovesical Sling Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
Control No sling placed at the time of prostatectomy

Participant Flow:   Overall Study
    Urethrovesical Sling     Control  
STARTED     73     77  
COMPLETED     58     60  
NOT COMPLETED     15     17  
Protocol Violation                 1                 2  
Procedure delayed; enrollment closed                 0                 1  
Lost to Follow-up                 10                 8  
Withdrawal by Subject                 4                 6  



  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.
147 patients were treated with the study procedure.

Reporting Groups
  Description
Urethrovesical Sling Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
Control No sling placed at the time of prostatectomy
Total Total of all reporting groups

Baseline Measures
    Urethrovesical Sling     Control     Total  
Number of Participants  
[units: participants]
  73     74     147  
Age  
[units: years]
Mean ± Standard Deviation
  60.9  ± 6.1     60.6  ± 7.1     60.8  ± 6.6  
Gender  
[units: participants]
     
Female     0     0     0  
Male     73     74     147  



  Outcome Measures

1.  Primary:   Number of Continent Patients Post Prostatectomy   [ Time Frame: 1 Month ]


  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: Jason Hodde, Clinical Affairs Manager
Organization: Cook Biotech Incorporated
phone: 765-497-3355
e-mail: jhodde@CookBiotech.com


No publications provided


Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00937833     History of Changes
Other Study ID Numbers: 08-015, 350017
Study First Received: July 10, 2009
Results First Received: October 1, 2014
Last Updated: November 5, 2014
Health Authority: United States: Institutional Review Board