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

This study has been completed.
Sponsor:
Information provided by:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00463554
First received: April 18, 2007
Last updated: January 26, 2009
Last verified: January 2009
  Purpose

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 Intervention
Stress Urinary Incontinence
Device: GYNECARE TVT-SECUR* System

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Clinical performance of TVT-SECUR* [ Time Frame: Screening and Day 35 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the results of the standing cough stress test [ Time Frame: Screening, Week 5, Months 6 and 12 ] [ Designated as safety issue: No ]
  • Intra- and post-operative complications [ Time Frame: Intraoperative, Week 5, Months 6 and 12 ] [ Designated as safety issue: Yes ]
  • Physician questionnaire results [ Time Frame: Months 2 and 12 ] [ Designated as safety issue: No ]
  • Urodynamics [ Time Frame: Screening, Week 5, Months 6 and 12 (post-operative optional) ] [ Designated as safety issue: No ]
  • QoL measures [ Time Frame: Screening, Week 5, Months 6 and 12 ] [ Designated as safety issue: No ]
  • Subject satisfaction. [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Anesthesia [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • Operative time [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: April 2006
Study Completion Date: December 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with stress urinary incontinence

Criteria

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.
  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: NCT00463554

Locations
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
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00028
Italy
University of Padova
Padova, Italy, 35128
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: David Robinson, MD Ethicon, Inc.
  More Information

No publications provided

Responsible Party: Judith Gauld, BSc (Hons), Ethicon Inc.
ClinicalTrials.gov Identifier: NCT00463554     History of Changes
Other Study ID Numbers: 300-05-002
Study First Received: April 18, 2007
Last Updated: January 26, 2009
Health Authority: United States: Institutional Review Board
Italy: Ethics Committee
Finland: Ethics Committee

Keywords provided by Ethicon, Inc.:
Incontinence
Stress Urinary

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 November 19, 2014