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

NCT00463554 | Completed

• 1 other identifier: 300-05-002
• Study Type: observational
• Target: 72
• Locations: 3 countries
• Sites: 6

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).

Conditions

Stress Urinary Incontinence

Keywords

Incontinence; Stress Urinary

Outcome Measures

Primary Outcomes (1)

• Clinical performance of TVT-SECUR*

  Screening and Day 35

Secondary Outcomes (8)

• 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

Interventions

GYNECARE TVT-SECUR* System DEVICE

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

Also known as: Sub-urethral sling

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with stress urinary incontinence

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (6)

Michigan Institute of Women's Health

Dearborn, Michigan, 48124, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220-2489, United States

Location

The Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, 18104, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Helsinki University Central Hospital

Helsinki, 00028, Finland

Location

University of Padova

Padua, 35128, Italy

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

• David Robinson, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 20, 2007
• Study Start: April 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

FI (1); IT (1); US (4)