Back to resultsTransvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)
Primary Purpose
Urinary Incontinence, Stress
Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
TVT Secur (Gynecare)
TVT (Gynecare)
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Stress
Eligibility 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
Sites / Locations
- Foothills Medical Centre
- Royal Alexandra Hospital
- Penticton Regional Hospital
- Lions Gate Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TVT Secur surgical device
TVT surgical device
Arm Description
Single incision tape device
Usual care retropubic tape device
Outcomes
Primary Outcome Measures
Standardised pad test: "cure" is defined as less than 1g gain in pad weight over the duration of the test
Secondary Outcome Measures
Subjective evidence of cure
Incontinence-related quality of life (UDI-6, IIQ-7)
Sexual function (PISQ-12)
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.
Return to usual activities
Voiding dysfunction
Surgical complications
Cost
Utility (15-D)
Full Information
NCT ID
NCT00685217
First Posted
May 22, 2008
Last Updated
August 29, 2016
Sponsor
University of Calgary
Collaborators
University of Alberta, Johnson & Johnson Medical Companies
1. Study Identification
Unique Protocol Identification Number
NCT00685217
Brief Title
Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)
Official Title
Tension-free Vaginal Tape Management of Stress Incontinence in Women: Randomized Trial of TVT Secur Versus TVT
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
University of Alberta, Johnson & Johnson Medical Companies
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TVT Secur surgical device
Arm Type
Experimental
Arm Description
Single incision tape device
Arm Title
TVT surgical device
Arm Type
Active Comparator
Arm Description
Usual care retropubic tape device
Intervention Type
Procedure
Intervention Name(s)
TVT Secur (Gynecare)
Intervention Description
Sling device for stress urinary incontinence
Intervention Type
Procedure
Intervention Name(s)
TVT (Gynecare)
Intervention Description
Sling procedure for stress urinary incontinence
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Subjective evidence of cure
Time Frame
12 months following surgery
Title
Incontinence-related quality of life (UDI-6, IIQ-7)
Time Frame
6 weeks and 12 months following surgery
Title
Sexual function (PISQ-12)
Time Frame
12 months following surgery
Title
Satisfaction with surgical outcome
Description
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.
Time Frame
12 months following surgery
Title
Return to usual activities
Time Frame
up to 12 months following surgery
Title
Voiding dysfunction
Time Frame
12 months following surgery
Title
Surgical complications
Time Frame
up to 12 months following surgery
Title
Cost
Time Frame
up to 12 momths following surgery
Title
Utility (15-D)
Time Frame
6 weeks and 12 months following surgery
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Ross, PhD
Organizational Affiliation
University of Calgary
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Magali Robert, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jane Schulz, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1C5
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Penticton Regional Hospital
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 3G6
Country
Canada
Facility Name
Lions Gate Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 2L7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The decision to share would depend on the protocol of an IPD analysis protocol
Citations:
PubMed Identifier
25532604
Citation
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.
Results Reference
result
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Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)
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