We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)

This study has been terminated.
(poor recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00685217
First Posted: May 28, 2008
Last Update Posted: August 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Alberta
Johnson & Johnson Medical Companies
Information provided by (Responsible Party):
Dr. Sue Ross, University of Calgary
  Purpose
This randomized multi-centre trial will recruit women with stress urinary incontinence who need surgical treatment for their condition. 300 women will be allocated either to receive a TVT Secur or a standard TVT surgical procedure. The main outcome is effectiveness of the procedure, determined using a 1-hour pad test (which tests for urine leakage) 12 months after surgery. The study will be carried out in 4 to 6 centers and will involve urogynaecologists, urologists and general obstetrician-gynaecologists: all clinicians will have received adequate training.

Condition Intervention Phase
Urinary Incontinence, Stress Procedure: TVT Secur (Gynecare) Procedure: TVT (Gynecare) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tension-free Vaginal Tape Management of Stress Incontinence in Women: Randomized Trial of TVT Secur Versus TVT

Resource links provided by NLM:


Further study details as provided by Dr. Sue Ross, University of Calgary:

Primary Outcome Measures:
  • Standardised pad test: "cure" is defined as less than 1g gain in pad weight over the duration of the test [ Time Frame: 12 months following surgery ]

Secondary Outcome Measures:
  • Subjective evidence of cure [ Time Frame: 12 months following surgery ]
  • Incontinence-related quality of life (UDI-6, IIQ-7) [ Time Frame: 6 weeks and 12 months following surgery ]
  • Sexual function (PISQ-12) [ Time Frame: 12 months following surgery ]
  • Satisfaction with surgical outcome [ Time Frame: 12 months following surgery ]
    Patients will be asked about the expectations they had before surgery, and asked if the outcome had met expectations. Women will be asked about satisfaction with the surgical outcome, if they would have the same operation again under the same circumstances, and if they would recommend the same operation to someone else with the same problem.

  • Return to usual activities [ Time Frame: up to 12 months following surgery ]
  • Voiding dysfunction [ Time Frame: 12 months following surgery ]
  • Surgical complications [ Time Frame: up to 12 months following surgery ]
  • Cost [ Time Frame: up to 12 momths following surgery ]
  • Utility (15-D) [ Time Frame: 6 weeks and 12 months following surgery ]

Enrollment: 74
Study Start Date: May 2008
Study Completion Date: April 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TVT Secur surgical device
Single incision tape device
Procedure: TVT Secur (Gynecare)
Sling device for stress urinary incontinence
Active Comparator: TVT surgical device
Usual care retropubic tape device
Procedure: TVT (Gynecare)
Sling procedure for stress urinary incontinence

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with stress incontinence, defined as leaking with increased abdominal pressure
  • Eligible for both types of surgery

Exclusion Criteria:

Women who:

  • Have vaginal prolapse requiring surgical repair
  • Have had previous incontinence surgery
  • Have overactive bladder or incontinence is caused only by bladder overflow
  • Intend to have further children
  • Have Alzheimer's or Parkinson's disease, progressive neurological disease such as multiple sclerosis, or are immunocompromised
  • Are unable to understand English
  • Will be unavailable for follow-up
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685217


Locations
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 1C5
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Penticton Regional Hospital
Penticton, British Columbia, Canada, V2A 3G6
Lions Gate Hospital
Vancouver, British Columbia, Canada, V7L 2L7
Sponsors and Collaborators
University of Calgary
University of Alberta
Johnson & Johnson Medical Companies
Investigators
Study Director: Sue Ross, PhD University of Calgary
Principal Investigator: Magali Robert, MD University of Calgary
Principal Investigator: Jane Schulz, MD University of Alberta
  More Information

Publications:
Responsible Party: Dr. Sue Ross, Adjunct Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00685217     History of Changes
Other Study ID Numbers: 21528
First Submitted: May 22, 2008
First Posted: May 28, 2008
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The decision to share would depend on the protocol of an IPD analysis protocol

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