Stress Urinary IncontinencePhase 3NCT01799122
Trial Comparing Mini-Arc Precise Pro and the Trans Vaginal Obturator Tape for Stress Urinary Incontinence
A Phase 3 study testing Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0) in people with Stress Urinary Incontinence and Urethral Sling Surgery, run by University of Manitoba at 1 site in Canada.
Trial summary
Randomized comparison of two surgeries for the treatment of female stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence, Urethral Sling Surgery
- What is being tested?
- Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Start not givento Feb 2017
- 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 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women with stress urinary incontinence with a positive cough test
- patient request surgery for treatment
Who cannot join
- prodominantely overactive bladder
- previous failed procedure
- MUCP <20 cm H2O
- presence of vaginal prolapse > stage 1
- voiding dysfunction (PVR>100 mL)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Ken Maslow
Winnipeg, Manitoba, R2H 2A6
Ken D Maslow, MD, 204-235-3039, kmaslow@sbgh.mb.ca
About this study
Official title: Randomized Clinical Trial Comparing Mini-Arc Precise Pro and the Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence
Randomized comparison of two surgeries for the treatment of female stress urinary incontinence.
- Being tested
- Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)
- 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.
Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)Device
| Study group | Role | What they receive |
|---|---|---|
| Precise sling vs TVT-O sling | Active comparator | Not described Receives: Device: Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough test at one year from surgery
Measured: One year
Secondary outcomes (1)
Subjective symptoms, QOL questionaires
Measured: 1 & 2 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Primary completionFeb 2017 (estimated)
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 Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ken Maslow, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799122
- Sponsor's protocol ID
- B2012:047
- Status last verified
- Jan 2016
- First submitted
- 22 Feb 2013
- Last updated
- 12 Jan 2016
- Results posted
- No
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 37888839
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 Mini-Arc Precise Pro and the Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01799122
- Acronym / sponsor ID
- B2012:047
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Primary completion
- Feb 2017 (estimated)
- First posted
- 26 Feb 2013 (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.
Randomized comparison of two surgeries for the treatment of female stress urinary incontinence.
Study design
- Primary purpose
- Treatment
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Precise sling vs TVT-O sling | Active comparator | Device: Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0) |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women with stress urinary incontinence with a positive cough test
- patient request surgery for treatment
Key exclusion criteria (5 listed)
- prodominantely overactive bladder
- previous failed procedure
- MUCP <20 cm H2O
- presence of vaginal prolapse > stage 1
- voiding dysfunction (PVR>100 mL)
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 |
|---|---|---|
| Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0) | Device | Precise sling vs TVT-O sling |
Primary outcome
Cough test at one year from surgery
Time frame: One year
1 secondary outcome
Subjective symptoms, QOL questionaires
Time frame: 1 & 2 years post surgery
Results and safety
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.
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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.
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 Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0) in people with Stress Urinary Incontinence and Urethral Sling Surgery, 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 2 inclusion and 5 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 NCT01799122, 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 12 Jan 2016.