Urinary Incontinence, StressPhase 3NCT00685217
Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)
A Phase 3 study testing TVT Secur (Gynecare) and TVT (Gynecare) in people with Urinary Incontinence, Stress, run by University of Calgary at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- TVT Secur (Gynecare) and TVT (Gynecare)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 4 sitesCanada
- Study dates
- May 2008to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with stress incontinence, defined as leaking with increased abdominal pressure
- Eligible for both types of surgery
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Foothills Medical Centre
Calgary, Alberta, T2N 1C5
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Penticton Regional Hospital
Penticton, British Columbia, V2A 3G6
Lions Gate Hospital
Vancouver, British Columbia, V7L 2L7
About this study
Official title: 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.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- TVT Secur (Gynecare), TVT (Gynecare)
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVT Secur (Gynecare)Procedure or surgery
Sling device for stress urinary incontinence
TVT (Gynecare)Procedure or surgery
Sling procedure for stress urinary incontinence
| Study group | Role | What they receive |
|---|---|---|
| TVT Secur surgical device | Experimental | Single incision tape device Receives: Procedure: TVT Secur (Gynecare) |
| TVT surgical device | Active comparator | Usual care retropubic tape device Receives: Procedure: TVT (Gynecare) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardised pad test: "cure" is defined as less than 1g gain in pad weight over the duration of the test
Measured: 12 months following surgery
Secondary outcomes (9)
Subjective evidence of cure
Measured: 12 months following surgery
Incontinence-related quality of life (UDI-6, IIQ-7)
Measured: 6 weeks and 12 months following surgery
Sexual function (PISQ-12)
Measured: 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.
Measured: 12 months following surgery
Return to usual activities
Measured: up to 12 months following surgery
Voiding dysfunction
Measured: 12 months following surgery
Surgical complications
Measured: up to 12 months following surgery
Cost
Measured: up to 12 momths following surgery
Utility (15-D)
Measured: 6 weeks and 12 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2011
- Study completionApr 2012
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, Johnson & Johnson Medical Companies
- Responsible party
- Principal investigator, Dr. Sue Ross, University of Calgary
- Investigators
- Sue Ross, PhD, Study director, University of CalgaryMagali Robert, MD, Principal investigator, University of CalgaryJane Schulz, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685217
- Sponsor's protocol ID
- 21528
- Status last verified
- Aug 2016
- First submitted
- 22 May 2008
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The decision to share would depend on the protocol of an IPD analysis protocol
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.
PubMed 25532604
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tension-free Vaginal Tape Management of Stress Incontinence in Women: Randomized Trial of TVT Secur Versus TVT
- ClinicalTrials.gov ID
- NCT00685217
- Acronym / sponsor ID
- 21528
- Conditions
- Urinary Incontinence, Stress
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Alberta, Johnson & Johnson Medical Companies
- Study start
- May 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TVT Secur surgical device | Experimental | Procedure: TVT Secur (Gynecare)Single incision tape device |
| TVT surgical device | Active comparator | Procedure: TVT (Gynecare)Usual care retropubic tape device |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women with stress incontinence, defined as leaking with increased abdominal pressure
- Eligible for both types of surgery
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TVT Secur (Gynecare)Sling device for stress urinary incontinence | Procedure or surgery | TVT Secur surgical device |
| TVT (Gynecare)Sling procedure for stress urinary incontinence | Procedure or surgery | TVT surgical device |
Primary outcome
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
9 secondary outcomes
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
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
Results and safety
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Results publication: PubMed 25532604Ross 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.
- Individual participant dataSharing planned: Undecided. The decision to share would depend on the protocol of an IPD analysis protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue Ross, PhD study director
University of Calgary
Magali Robert, MD principal investigator
University of Calgary
Jane Schulz, MD principal investigator
University of Alberta
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TVT Secur (Gynecare) and TVT (Gynecare) in people with Urinary Incontinence, Stress, run by University of Calgary at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00685217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.