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ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males (ProACT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Uromedica
ClinicalTrials.gov Identifier:
NCT00277095
First received: January 11, 2006
Last updated: January 4, 2016
Last verified: January 2016
Results First Received: January 30, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Urinary Incontinence
Intervention: Device: ProACT (Adjustable Continence Therapy)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Implantable Device ProACT Implantable device for treatment of post-prostatectomy stress urinary incontinence in males.

Participant Flow:   Overall Study
    Implantable Device
STARTED   124 [1] 
COMPLETED   103 [2] 
NOT COMPLETED   21 
Death                2 
Explanted                7 
Lost to Follow-up                2 
Missed Follow-up                9 
Physician Decision                1 
[1] Anatomy of 1 patient did not allow ProACT to be implanted, hence only 123 patients were implanted.
[2] Details of patients who did not complete study are given below.



  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.
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Reporting Groups
  Description
ProACT Implantable device

Baseline Measures
   ProACT 
Overall Participants Analyzed 
[Units: Participants]
 124 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.7  (7.9) 
Gender 
[Units: Participants]
 
Female   0 
Male   124 
Region of Enrollment 
[Units: Participants]
 
United States   68 
Canada   44 
New Zealand   12 


  Outcome Measures

1.  Primary:   Primary Efficacy: Demonstrate the Efficacy of the ProACT Device in Reducing Incontinence as Measured by the 24-hour Pad Weight at 18 Months Compared to Baseline. A Subject is a Success if he Demonstrates a 50% Reduction.   [ Time Frame: 18 month follow-up ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Sabitha R Shriram
Organization: Uromedica
phone: 763-694-9880 ext 216
e-mail: sshriram@uromedica-inc.com



Responsible Party: Uromedica
ClinicalTrials.gov Identifier: NCT00277095     History of Changes
Other Study ID Numbers: UM02
Study First Received: January 11, 2006
Results First Received: January 30, 2013
Last Updated: January 4, 2016
Health Authority: United States: Food and Drug Administration