TVT-SECUR A Pilot Study for the Treatment of Stress Urinary Incontinence

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. Identifier: NCT00463554
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : January 27, 2009
Information provided by:
Ethicon, Inc.

Brief Summary:
The primary objective of this study is to obtain clinical performance information on the GYNECARE TVT-SECUR* System (Tension-free Support for Incontinence) in women with stress urinary incontinence (SUI).

Condition or disease Intervention/treatment
Stress Urinary Incontinence Device: GYNECARE TVT-SECUR* System

Detailed Description:
The primary variable for effectiveness is > 50% improvement on the subjective symptom Visual Analog Scale (VAS) at Visit 3/Week 5 (35 days post-surgery) to be accepted.

Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Evaluation of the GYNECARE TVT-SECUR* System (Tension-Free Support for Incontinence) for the Treatment of Stress Urinary Incontinence *Trademark
Study Start Date : April 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: GYNECARE TVT-SECUR* System
    A sub-urethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency
    Other Name: Sub-urethral sling

Primary Outcome Measures :
  1. Clinical performance of TVT-SECUR* [ Time Frame: Screening and Day 35 ]

Secondary Outcome Measures :
  1. Assessment of the results of the standing cough stress test [ Time Frame: Screening, Week 5, Months 6 and 12 ]
  2. Intra- and post-operative complications [ Time Frame: Intraoperative, Week 5, Months 6 and 12 ]
  3. Physician questionnaire results [ Time Frame: Months 2 and 12 ]
  4. Urodynamics [ Time Frame: Screening, Week 5, Months 6 and 12 (post-operative optional) ]
  5. QoL measures [ Time Frame: Screening, Week 5, Months 6 and 12 ]
  6. Subject satisfaction. [ Time Frame: Month 12 ]
  7. Anesthesia [ Time Frame: intraoperative ]
  8. Operative time [ Time Frame: Intraoperative ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with stress urinary incontinence

Inclusion Criteria:

  • Must be female with objective, demonstratable signs of SUI or stress predominant mixed incontinence and requires elective, primary surgical intervention.
  • Must be at least 21 years old.
  • Must be postmenopausal (amenorrhea) for at least 1 year or surgically sterile (bilateral salpingo-oophorectomy or tubal ligation or otherwise be incapable of pregnancy) or has a negative pregnancy test prior to study entry and has decided to cease childbearing.
  • Agrees to participate in the study, including all study related procedures and evaluations and documents this agreement by signing the IRB/EC-approved informed consent

Exclusion Criteria:

  • Have any other coexistent pathology requiring concomitant surgery that may impact this procedure i.e. surgeries that involve the anterior vaginal wall (e.g. anterior colporrhaphy, diverticula, anterior Prolift) Any allowable concomitant surgery must be performed prior to the GYNECARE TVT SECUR System surgery.
  • Have intrinsic sphincter deficiency (ISD) [Urethral Pressure Profile (UPP) with a maximum urethral closing pressure (MUCP) < 20cm H2O or Leak Point Pressure (LPP) < 60].
  • Have an active urinary tract infection (UTI) or vaginal infection at time of surgery.
  • Have a fixed urethra (< 30° mobility on Q-Tip Straining Test).
  • Have had prior incontinence surgery.
  • Have a post-void residual volume > 100mL.
  • Have co-existent pelvic organ prolapse that is symptomatic or extends beyond the hymen.
  • Have lower urinary tract pathology in the form of a fistula or diverticulum.
  • Have a malignancy or with a history of malignancy within the past 5 years, except for a basal cell carcinoma that has been treated with local excision and is no longer present.
  • Are on anticoagulant therapy.
  • Have received an experimental drug or used an experimental medical device within 30 days prior to the planned start of treatment.
  • Are deemed by the investigator as medically unfit for surgery or who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings or contraindications outlined in the GYNECARE TVT SECUR System IFU.
  • Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center.

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 identifier (NCT number): NCT00463554

United States, Michigan
Michigan Institute of Women's Health
Dearborn, Michigan, United States, 48124
United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220-2489
United States, Pennsylvania
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States, 18104
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Helsinki University Central Hospital
Helsinki, Finland, 00028
University of Padova
Padova, Italy, 35128
Sponsors and Collaborators
Ethicon, Inc.
Study Director: David Robinson, MD Ethicon, Inc.

Responsible Party: Judith Gauld, BSc (Hons), Ethicon Inc. Identifier: NCT00463554     History of Changes
Other Study ID Numbers: 300-05-002
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: January 27, 2009
Last Verified: January 2009

Keywords provided by Ethicon, Inc.:
Stress Urinary

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