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

This study has been completed.
Sponsor:
Collaborators:
Good Samaritan Hospital, Ohio
Greater Baltimore Medical Center, Baltimore MD
Washington Hospital Center
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
ClinicalTrials.gov Identifier:
NCT00534365
First received: September 20, 2007
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Stress Urinary Incontinence
Device: tension-free vaginal tape
Device: TVT-SECUR device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • The primary outcome will be the subjective cure of urinary incontinence at 12 months after surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications [ Time Frame: 6 week, 6 month, 1 year, 2 years ] [ Designated as safety issue: Yes ]
  • Objective Cure of stress incontinence (standing stress test) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Postoperative pain [ Time Frame: 2 weeks, 6 weeks ] [ Designated as safety issue: No ]
  • HRQOL [ Time Frame: 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
  • Irritative voiding symptoms & urinary retention [ Time Frame: 6 ,12, 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 281
Study Start Date: August 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534365

Locations
United States, District of Columbia
Washington Hospital Center
Washington, 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, Baltimore MD
Washington Hospital Center
Duke University
Foundation for Female Health Awareness
Women and Infants Hospital of Rhode Island
Main Line Health
Investigators
Principal Investigator: Matthew D Barber, MD, MHS The Cleveland Clinic
  More Information

Additional Information:
Publications:
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00534365     History of Changes
Other Study ID Numbers: FFHA 07-01
Study First Received: September 20, 2007
Last Updated: August 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
stress urinary incontinence
sling procedures
tension-free vaginal tape

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 23, 2014