Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)

This study has been terminated.
(Study design required a change in device)
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01029106
First received: October 19, 2009
Last updated: July 27, 2011
Last verified: July 2011
  Purpose

This is a prospective, non-randomized, observational, multicentre (5 sites) study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a TVT SECUR operative procedure.

The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires, Intraoperative procedural data will be collected.

Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals up to 24 months. The anatomic position of the device will be characterize by transvaginal ultrasound testing.

To determine the rate and/or improvement rate of patients who have received the Gynecare Secur device after 12 months and after 24 months.


Condition Intervention
Stress Urinary Incontinence
Procedure: Gynecare TVT Secur

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective, Non-Randomized, Observational, Multicentre, Study of the TVT Secur in the Surgical Management of Women With Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • The primary endpoints are the cure/improvement rate in the cohort at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distribution of percentage of subjects having a decrease of pad weight as compared to baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Decrease in number of pads used within a 24-hour period as compared to baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Change in patient questionnaires from baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Change in the sling position on transvaginal ultrasound [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Cure/improvement rate at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: September 2009
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Gynecare TVT Secur
    Implant of the Gynecare TVT Secur
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Approximately 125 women with SUI from 5 centres across Canada will participate in this study.

Criteria

Inclusion Criteria:

To be considered eligible to participate in this study, subjects must meet the following requirements:

  1. Subject has agreed to undergo surgical implantation of the TVT SECUR System
  2. Subject has the complaint of SUI for at least 6 months prior to the Preoperative Evaluation Visit.
  3. Subject has confirmed SUI resulting from urethral hypermobility on cough stress testing.
  4. Subject has at least 4 gm of urine leakage on 1-hour pad testing during the Preoperative Screening Visit.
  5. Subject is at least 18 years of age to maximum of 85 years of age
  6. Subject is willing and able to give written informed consent prior to any study related procedures.
  7. Subject is willing to return for follow-up evaluation and questionnaire completion at 4-6 weeks, and at 3, 6, 12 and 24 month follow-ups.
  8. Subject is willing to undergo transvaginal ultrasound evaluation at the 4 weeks and 12 month follow-up visit.

Exclusion Criteria:

Subjects will not be eligible for entry into the study if they meet one of the following criteria:

  1. Subject is pregnant.
  2. Subject has had any previous synthetic sub-urethral sling procedure.
  3. Subject has current urinary tract or vaginal infections.
  4. Subject has blood coagulation disorders.
  5. Subject has a compromised immune system or any other conditions that would compromise healing.
  6. Subject has upper urinary tract obstruction.
  7. Subject is unwilling to provide written informed consent.
  8. Subject is unwilling or unable to return for evaluation at 4-6 weeks, and at 3, 6, 12, and 24 months.
  9. Subject has uncontrolled detrusor overactivity.
  10. Subject has PVR greater than 100 cc.
  11. Subject has Peak Flow Rate less than 10 ml/sec.
  12. Subject has urethral diverticulum.
  13. Subject has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
  14. Subject has had radiation therapy to the pelvic area at any time.
  15. Subject has current or active history of pelvic cancer.
  16. Subject who in the opinion of the investigator is unable and/or unlikely to comprehend the nature, scope and possible consequences of the study and to follow the study procedures and instructions and complete all study related measurements.
  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: NCT01029106

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Johnson & Johnson
Investigators
Principal Investigator: Sender Herschorn, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Sender Herschorn, MD, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01029106     History of Changes
Other Study ID Numbers: TVTSecur, 047-2009
Study First Received: October 19, 2009
Last Updated: July 27, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
SUI
Stress Urinary Incontinence
Patients with Stress Urinary Incontinence

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

ClinicalTrials.gov processed this record on August 19, 2014