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Completed

NCT Number: NCT00534365

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

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Washington Hospital Center, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tension-free Vaginal Tape

Device

Retropubic mid-urethral sling

Other names: TVT

TVT-SECUR device

Device

Mid-urethral mini-sling

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Duke University
  • Foundation for Female Health Awareness
  • Good Samaritan Hospital, Ohio
  • Greater Baltimore Medical Center
  • Main Line Health
  • Medstar Health Research Institute
  • Women and Infants Hospital of Rhode Island

Registry information

Official study title

A Randomized Trial Comparing Tension-free Vaginal Tape (TVT) to the TVT-SECUR for the Surgical Treatment of Stress Urinary Incontinence

Acronym: SECURiTy

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 24, 2007
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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