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Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence (SECURiTy)

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.
 
ClinicalTrials.gov Identifier: NCT00534365
Recruitment Status : Completed
First Posted : September 24, 2007
Results First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Sponsor:
Collaborators:
Good Samaritan Hospital, Ohio
Greater Baltimore Medical Center
Medstar Health Research Institute
Duke University
Foundation for Female Health Awareness
Women and Infants Hospital of Rhode Island
Main Line Health
Information provided by (Responsible Party):
The Cleveland Clinic

Study Description
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Brief Summary:
The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary incontinence.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: tension-free vaginal tape Device: TVT-SECUR device Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Tension-free Vaginal Tape (TVT) to the TVT-SECUR for the Surgical Treatment of Stress Urinary Incontinence
Study Start Date : August 2007
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Tension-free vaginal tape procedure (TVT)
 Device: tension-free vaginal tape
Retropubic mid-urethral sling
Other Name: TVT
Active Comparator: 2
TVT-SECUR device
 Device: TVT-SECUR device
Mid-urethral mini-sling


Outcome Measures
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Primary Outcome Measures :
  1. Subjective Cure of Urinary Incontinence at 12 Months After Surgery [ Time Frame: 12 months ]
    Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.


Secondary Outcome Measures :
  1. Post Operative Complications at 6 Week or Less [ Time Frame: 6 week ]
  2. Long Term Complications > 6 Weeks [ Time Frame: 6 weeks-12 months ]
  3. Patient Global Impression Improvement [ Time Frame: 12 months ]
  4. Incontinence Severity Index Score [ Time Frame: 12 months ]
    The incontinence severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe).


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Urinary incontinence symptoms
  • Urodynamic stress incontinence confirmed with multichannel urodynamic testing
  • Age of at least 21 years
  • Desires surgical correction of stress urinary incontinence

Exclusion Criteria:

  • Post-void residual volume >100cc
  • Detrusor overactivity on preoperative multichannel urodynamic testing
  • History of previous synthetic, biologic or fascial sub-urethral sling
  • Desires future childbearing
  • History of bleeding diathesis or current anti-coagulation therapy
  • Current genitourinary fistula or urethral diverticulum
  • Reversible cause of incontinence (i.e. drug effect)
  • Contraindication to surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534365


Locations
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United States, District of Columbia
Washington Hospital Center
Washington, D.C., District of Columbia, United States, 20010
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27706
United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45520
Cleveland Clinic
Cleveland, Ohio, United States, 44145
United States, Pennsylvania
Main Line Health
Paoli, Pennsylvania, United States, 19301
United States, Rhode Island
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Cleveland Clinic
Good Samaritan Hospital, Ohio
Greater Baltimore Medical Center
Medstar Health Research Institute
Duke University
Foundation for Female Health Awareness
Women and Infants Hospital of Rhode Island
Main Line Health
Investigators
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Principal Investigator: Matthew D Barber, MD, MHS The Cleveland Clinic
More Information
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Publications of Results:

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00534365    
Other Study ID Numbers: FFHA 07-01
First Posted: September 24, 2007    Key Record Dates
Results First Posted: June 9, 2017
Last Update Posted: June 9, 2017
Last Verified: May 2017
Keywords provided by The Cleveland Clinic:
stress urinary incontinence
sling procedures
tension-free vaginal tape
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders