Stress Urinary IncontinencePhase 3NCT00527696
Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence
A Phase 3 study testing transvaginal obturator tape in people with Stress Urinary Incontinence, run by University of Manitoba at 1 site in Canada.
Trial summary
To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal obturator tape (TVT-O) procedures for the surgical management of female stress urinary incontinence. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- transvaginal obturator tape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to Oct 2011
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Female patients with symptoms of stress urinary incontinence and a positive cough test who require surgical management. Cough test is positive when leakage of urine is seen from the urethra synchronously with the patient performing a cough or valsalva manuver with a comfortably full bladder in the lying or standing position.
Who cannot join
- Women with predominantly symptoms of urge urinary incontinence
- Presence of prolapse greater than Pelvic organ prolapse quantification (POPQ) Stage 1 or prolapse requiring surgery
- Detrusor overactivity on cystometrogram at urodynamic testing
- Previous surgery for incontinence
- Intrinsic sphincter deficiency (MUCP<20 cm H2O or Q -tip <30o)
- Voiding dysfunction with postvoid residual >100 cc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Comparing TVT SECUR System (TVT S) and Trans Vaginal Obturator Tape (TVT-O) for Surgical Management of Stress Urinary Incontinence
To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal obturator tape (TVT-O) procedures for the surgical management of female stress urinary incontinence.
- Conditions
- Stress Urinary Incontinence
- Being tested
- transvaginal obturator tape
- 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.
transvaginal obturator tapeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| TVT SECURE | Active comparator | sling Receives: Procedure: transvaginal obturator tape |
| TVT O | Active comparator | sling Receives: Procedure: transvaginal obturator tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective cure as defined by the cough test at one year from surgery
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startMay 2008
- Primary completionSep 2011
- Study completionOct 2011
Why it stopped: statistical Significance was reached for primary outcome
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ken Maslow, University of Manitoba
- Investigators
- Ken D Maslow, MD, Principal investigator, St. Boniface Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527696
- Sponsor's protocol ID
- B2007:044
- Status last verified
- Jan 2016
- First submitted
- 10 Sep 2007
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
PubMed 37888839Maslow K, Gupta C, Klippenstein P, Girouard L. Randomized clinical trial comparing TVT Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence. Int Urogynecol J. 2014 Jul;25(7):909-14. doi: 10.1007/s00192-013-2312-7. Epub 2014 Jan 23.
PubMed 24452619
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing TVT SECUR System (TVT S) and Trans Vaginal Obturator Tape (TVT-O) for Surgical Management of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00527696
- Acronym / sponsor ID
- B2007:044
- Conditions
- Stress Urinary Incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: statistical Significance was reached for primary outcome
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Sep 2007 (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.
To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal obturator tape (TVT-O) procedures for the surgical management of female stress urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TVT SECURE | Active comparator | Procedure: transvaginal obturator tapesling |
| TVT O | Active comparator | Procedure: transvaginal obturator tapesling |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients with symptoms of stress urinary incontinence and a positive cough test who require surgical management. Cough test is positive when leakage of urine is seen from the urethra synchronously with the patient performing a cough or valsalva manuver with a comfortably full bladder in the lying or standing position.
Key exclusion criteria (6 listed)
- Women with predominantly symptoms of urge urinary incontinence
- Presence of prolapse greater than Pelvic organ prolapse quantification (POPQ) Stage 1 or prolapse requiring surgery
- Detrusor overactivity on cystometrogram at urodynamic testing
- Previous surgery for incontinence
- Intrinsic sphincter deficiency (MUCP<20 cm H2O or Q -tip <30o)
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 |
|---|---|---|
| transvaginal obturator tape | Procedure or surgery | TVT O, TVT SECURE |
Primary outcome
Objective cure as defined by the cough test at one year from surgery
Time frame: one year
Results and safety
The study was stopped early (reason given: statistical Significance was reached for primary outcome). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Derived from this study: PubMed 37888839Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
- Derived from this study: PubMed 24452619Maslow K, Gupta C, Klippenstein P, Girouard L. Randomized clinical trial comparing TVT Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence. Int Urogynecol J. 2014 Jul;25(7):909-14. doi: 10.1007/s00192-013-2312-7. Epub 2014 Jan 23.
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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.
Ken D Maslow, MD principal investigator
St. Boniface Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing transvaginal obturator tape in people with Stress Urinary Incontinence, run by University of Manitoba at 1 site 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 1 inclusion and 6 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 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: statistical Significance was reached for primary outcome). 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?
Objective cure as defined by the cough test at one year from surgery (time frame: one year). 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 NCT00527696, which also lists 2 linked publications.
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 12 Jan 2016.