Working… Menu

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

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. Identifier: NCT00685217
Recruitment Status : Terminated (poor recruitment)
First Posted : May 28, 2008
Last Update Posted : August 31, 2016
University of Alberta
Johnson & Johnson Medical Companies
Information provided by (Responsible Party):
Dr. Sue Ross, University of Calgary

Brief Summary:
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 or disease Intervention/treatment Phase
Urinary Incontinence, Stress Procedure: TVT Secur (Gynecare) Procedure: TVT (Gynecare) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Subjective evidence of cure [ Time Frame: 12 months following surgery ]
  2. Incontinence-related quality of life (UDI-6, IIQ-7) [ Time Frame: 6 weeks and 12 months following surgery ]
  3. Sexual function (PISQ-12) [ Time Frame: 12 months following surgery ]
  4. 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.

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

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.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00685217

Layout table for location information
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
Layout table for investigator information
Study Director: Sue Ross, PhD University of Calgary
Principal Investigator: Magali Robert, MD University of Calgary
Principal Investigator: Jane Schulz, MD University of Alberta

Publications of Results:
Layout table for additonal information
Responsible Party: Dr. Sue Ross, Adjunct Professor, University of Calgary Identifier: NCT00685217     History of Changes
Other Study ID Numbers: 21528
First Posted: May 28, 2008    Key Record Dates
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:
Layout table for MeSH terms
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms