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

NCT ID: NCT00463554

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-04-01
• Study Completion Date: 2007-12-01

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).

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.

Conditions

Stress Urinary Incontinence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

GYNECARE TVT-SECUR* System

A sub-urethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency

Intervention Type: DEVICE

Other Intervention Names

Sub-urethral sling

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Robinson, MD

Role: STUDY_DIRECTOR

Ethicon, Inc.

Locations

Michigan Institute of Women's Health

Dearborn, Michigan, United States

Good Samaritan Hospital

Cincinnati, Ohio, United States

The Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

Helsinki University Central Hospital

Helsinki, , Finland

University of Padova

Padua, , Italy

Countries

United States; Finland; Italy

Other Identifiers

300-05-002

Identifier Type: -

Identifier Source: org_study_id