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

Tension-free Vaginal Tape Management of Stress Incontinence in Women: Randomized Trial of TVT Secur Versus TVT

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.

Study Overview

• Status: Terminated
• Conditions: Urinary Incontinence, Stress
• Intervention / Treatment: Procedure: TVT Secur (Gynecare); Procedure: TVT (Gynecare)

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1C5
      • Foothills Medical Centre
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital
  • British Columbia
    • Penticton, British Columbia, Canada, V2A 3G6
      • Penticton Regional Hospital
    • Vancouver, British Columbia, Canada, V7L 2L7
      • Lions Gate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective evidence of cure		12 months following surgery
Incontinence-related quality of life (UDI-6, IIQ-7)		6 weeks and 12 months following surgery
Sexual function (PISQ-12)		12 months following surgery
Satisfaction with surgical outcome	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.	12 months following surgery
Return to usual activities		up to 12 months following surgery
Voiding dysfunction		12 months following surgery
Surgical complications		up to 12 months following surgery
Cost		up to 12 momths following surgery
Utility (15-D)		6 weeks and 12 months following surgery

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: University of Alberta; Johnson & Johnson Medical Companies
• Investigators: Study Director: Sue Ross, PhD, University Of Calgary; Principal Investigator: Jane Schulz, MD, University of Alberta

Publications and helpful links

General Publications

• Ross S, Tang S, Schulz J, Murphy M, Goncalves J, Kaye S, Dederer L, Robert M. Single incision device (TVT Secur) versus retropubic tension-free vaginal tape device (TVT) for the management of stress urinary incontinence in women: a randomized clinical trial. BMC Res Notes. 2014 Dec 22;7:941. doi: 10.1186/1756-0500-7-941.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: May 22, 2008
• First Submitted That Met QC Criteria: May 27, 2008
• First Posted (Estimate): May 28, 2008

Study Record Updates

• Last Update Posted (Estimate): August 31, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: 21528

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The decision to share would depend on the protocol of an IPD analysis protocol