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

An Evaluation of the GYNECARE TVT-SECUR* System (Tension-free Support for Incontinence) for the Treatment of Stress Urinary Incontinence *Trademark

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).

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: 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
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00028
    • Helsinki University Central Hospital
• Italy
  • Padova, Italy, 35128
    • University of Padova
• United States
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Michigan Institute of Women's Health
  • Ohio
    • Cincinnati, Ohio, United States, 45220-2489
      • Good Samaritan Hospital
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • The Institute for Female Pelvic Medicine and Reconstructive Surgery
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women with stress urinary incontinence

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical performance of TVT-SECUR*	Screening and Day 35

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of the results of the standing cough stress test	Screening, Week 5, Months 6 and 12
Intra- and post-operative complications	Intraoperative, Week 5, Months 6 and 12
Physician questionnaire results	Months 2 and 12
Urodynamics	Screening, Week 5, Months 6 and 12 (post-operative optional)
QoL measures	Screening, Week 5, Months 6 and 12
Subject satisfaction.	Month 12
Anesthesia	intraoperative
Operative time	Intraoperative

Collaborators and Investigators

• Sponsor: Ethicon, Inc.
• Investigators: Study Director: David Robinson, MD, Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2006
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: April 18, 2007
• First Submitted That Met QC Criteria: April 18, 2007
• First Posted (Estimated): April 20, 2007

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Incontinence; Stress Urinary
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 300-05-002