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

This study has been terminated.
(poor recruitment)
Sponsor:
Collaborators:
University of Alberta
Johnson & Johnson
Information provided by (Responsible Party):
Dr. Sue Ross, University of Calgary
ClinicalTrials.gov Identifier:
NCT00685217
First received: May 22, 2008
Last updated: August 14, 2013
Last verified: August 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective evidence of cure [ Time Frame: 12 months following surgery ] [ Designated as safety issue: No ]
  • Incontinence-related quality of life (UDI-6, IIQ-7) [ Time Frame: 6 weeks and 12 months following surgery ] [ Designated as safety issue: No ]
  • Sexual function (PISQ-12) [ Time Frame: 12 months following surgery ] [ Designated as safety issue: No ]
  • Satisfaction with surgical outcome [ Time Frame: 12 months following surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Voiding dysfunction [ Time Frame: 12 months following surgery ] [ Designated as safety issue: Yes ]
  • Surgical complications [ Time Frame: up to 12 months following surgery ] [ Designated as safety issue: Yes ]
  • Cost [ Time Frame: up to 12 momths following surgery ] [ Designated as safety issue: No ]
  • Utility (15-D) [ Time Frame: 6 weeks and 12 months following surgery ] [ Designated as safety issue: No ]

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: A Procedure: TVT Secur (Gynecare)
Sling device for stress urinary incontinence
Active Comparator: B Procedure: TVT (Gynecare)
Sling procedure for stress urinary incontinence

  Eligibility

Genders 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
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: 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
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

No publications provided

Responsible Party: Dr. Sue Ross, Adjunct Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00685217     History of Changes
Other Study ID Numbers: 21528
Study First Received: May 22, 2008
Last Updated: August 14, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 30, 2014