Female Stress Urinary IncontinencePhase 4suiNCT01094353
A Comparative Study Minisling Versus Transobturator (TOT)Sling
A Phase 4 study testing Mini-sling and Transobturator in people with Female Stress Urinary Incontinence, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot with minisling. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Stress Urinary Incontinence
- What is being tested?
- Mini-sling and Transobturator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2008to Jul 2015
- Phase
- Phase 4
- 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 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinical and urodynamic diagnosis of SUI in patients between 18 and 90 years
Who cannot join
- postvoid residual urine volume more than 100 ml, coagulation disorders, current urinary tract infection, sequelae of previous radiation therapy of the pelvis, anticoagulant therapy, vulvovaginitis, and anesthesia contraindication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Trial of Ophira™ Minisling System and Unitape™ for the Treatment of Stress Urinary Incontinence in Women
A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot with minisling.
Read the detailed description
eligibility criteria was : female stress urinary incontinence
- Conditions
- Female Stress Urinary Incontinence
- Being tested
- Mini-sling, Transobturator
- Keywords
- Urodynamic Stress urinary incontinence, Minisling, Ophira™, Unitape™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-slingProcedure or surgery
Also called Mini-sling Ophira™
The minisling is a new intervention therapeutic option for surgical treatment in women with stress urinary incontinence. It is made of polypropylene monofilament mesh, held between two self-anchoring polypropylene columns in a fishbone design connected to two delivering needles.
TransobturatorProcedure or surgery
Also called Transobturator Sling Unitape™
Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence
| Study group | Role | What they receive |
|---|---|---|
| Mini-sling | Active comparator | The minisling Ophira™ is a new intervention therapeutic option for surgical treatment in women with stress urinary incontinence. It is made of polypropylene monofilament mesh, held between two self-anchoring polypropylene columns in a fishbone design connected to two delivering needles. Receives: Procedure: Mini-sling |
| Transobturator | Active comparator | Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence Receives: Procedure: Transobturator |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess efficacy between tot with minisling in cure in women with stress urinary incontinence
to assess efficacy and safety of minisling and transobturator sling in treatment of female stress urinary incontinence
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 posted26 Mar 2010 (estimated)
- Study startJun 2008
- Primary completionDec 2011
- Study completionJul 2015
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 Female 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical, prospective, single-center, randomized controlled trial comparing the efficacy and safety of a single-incision mini-sling and a transobturator midurethral sling for female stress urinary incontinence (SUI) treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Livia Garcia Pascom, Federal University of São Paulo
- Investigators
- Ana LG Pascom, Pg, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094353
- Sponsor's protocol ID
- ophira
- Acronym
- sui
- Status last verified
- Jun 2017
- First submitted
- 24 Mar 2010
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
De Ridder D, Berkers J, Deprest J, Verguts J, Ost D, Hamid D, Van der Aa F. Single incision mini-sling versus a transobutaror sling: a comparative study on MiniArc and Monarc slings. Int Urogynecol J. 2010 Jul;21(7):773-8. doi: 10.1007/s00192-010-1127-z. Epub 2010 Mar 4.
PubMed 20204323Djehdian LM, Araujo MP, Takano CC, Del-Roy CA, Sartori MGF, Girao MJBC, Castro RA. Transobturator sling compared with single-incision mini-sling for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2014 Mar;123(3):553-561. doi: 10.1097/AOG.0000000000000148.
PubMed 24499750
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial of Ophira™ Minisling System and Unitape™ for the Treatment of Stress Urinary Incontinence in Women
- ClinicalTrials.gov ID
- NCT01094353
- Acronym / sponsor ID
- sui / ophira
- Conditions
- Female Stress Urinary Incontinence
- Keywords
- Urodynamic Stress urinary incontinence, Minisling, Ophira™, Unitape™
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jun 2008 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Mar 2010 (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.
A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot with minisling.
Detailed description
eligibility criteria was : female stress urinary incontinence
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Clinical, prospective, single-center, randomized controlled trial comparing the efficacy and safety of a single-incision mini-sling and a transobturator midurethral sling for female stress urinary incontinence (SUI) treatment.
| Arm | Type | Receives |
|---|---|---|
| Mini-sling | Active comparator | Procedure: Mini-slingThe minisling Ophira™ is a new intervention therapeutic option for surgical treatment in women with stress urinary incontinence. It is made of polypropylene monofilament mesh, held between two self-anchoring polypropylene columns in a fishbone design connected to two delivering needles. |
| Transobturator | Active comparator | Procedure: TransobturatorTransobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical and urodynamic diagnosis of SUI in patients between 18 and 90 years
Key exclusion criteria (1 listed)
- postvoid residual urine volume more than 100 ml, coagulation disorders, current urinary tract infection, sequelae of previous radiation therapy of the pelvis, anticoagulant therapy, vulvovaginitis, and anesthesia contraindication
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-slingAlso: Mini-sling Ophira™The minisling is a new intervention therapeutic option for surgical treatment in women with stress urinary incontinence. It is made of polypropylene monofilament mesh, held between two self-anchoring polypropylene columns in a fishbone design connected to two delivering needles. | Procedure or surgery | Mini-sling |
| TransobturatorAlso: Transobturator Sling Unitape™Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence | Procedure or surgery | Transobturator |
Primary outcome
to assess efficacy between tot with minisling in cure in women with stress urinary incontinence
Time frame: one year
to assess efficacy and safety of minisling and transobturator sling in treatment of female stress urinary incontinence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Results publication: PubMed 20204323De Ridder D, Berkers J, Deprest J, Verguts J, Ost D, Hamid D, Van der Aa F. Single incision mini-sling versus a transobutaror sling: a comparative study on MiniArc and Monarc slings. Int Urogynecol J. 2010 Jul;21(7):773-8. doi: 10.1007/s00192-010-1127-z. Epub 2010 Mar 4.
- Derived from this study: PubMed 24499750Djehdian LM, Araujo MP, Takano CC, Del-Roy CA, Sartori MGF, Girao MJBC, Castro RA. Transobturator sling compared with single-incision mini-sling for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2014 Mar;123(3):553-561. doi: 10.1097/AOG.0000000000000148.
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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.
Ana LG Pascom, Pg principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mini-sling and Transobturator in people with Female Stress Urinary Incontinence, run by Federal University of São Paulo at 1 site in Brazil.
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 1 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: finished, as of the sponsor's last update on 21 Jun 2017. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
to assess efficacy between tot with minisling in cure in women with stress urinary incontinence (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 NCT01094353, 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 21 Jun 2017.