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TVT-SECUR as an Office-based Procedure (TVTSOffice)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01137539
First Posted: June 4, 2010
Last Update Posted: June 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Salil Khandwala MD, Michigan Institution of Women's Health PC
Results First Submitted: April 12, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Urinary Incontinence
Stress Urinary Incontinence
Intervention: Device: Gynecare TVT-SECUR system

  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
Recruitment period: October 2008-May 2009 at medical practice

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
Gynecare TVT-SECUR System

All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence

Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence


Participant Flow:   Overall Study
    Gynecare TVT-SECUR System
STARTED   50 
COMPLETED   50 
NOT COMPLETED   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
Gynecare TVT-SECUR System

All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence

Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence


Baseline Measures
   Gynecare TVT-SECUR System 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      49  98.0% 
>=65 years      1   2.0% 
Age 
[Units: Years]
Median (Standard Deviation)
 46.7  (8.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      50 100.0% 
Male      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
White   47 
Hispanic or Latino   3 
Region of Enrollment 
[Units: Participants]
 
United States   50 


  Outcome Measures
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1.  Primary:   Treatment Success Based on Patient Report on Validated Questionnaire   [ Time Frame: 24 months ]

2.  Secondary:   Patient Satisfaction   [ Time Frame: 12 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Salil Khandwala/Medical Director
Organization: Michigan Institute of Women's Health
phone: 313-982-0200



Responsible Party: Salil Khandwala MD, Michigan Institution of Women's Health PC
ClinicalTrials.gov Identifier: NCT01137539     History of Changes
Other Study ID Numbers: MIWH08-001
First Submitted: May 24, 2010
First Posted: June 4, 2010
Results First Submitted: April 12, 2017
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017