Injury Due to Sling-shotNCT02540525
Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence
A study testing Ophira and Transobturator sling in people with Injury Due to Sling-shot, run by Faculdade de Medicina do ABC at 1 site in Brazil.
Trial summary
1. OBJECTIVE: To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence (SUI) treatment. 2. METHODS: This prospective single-center randomized controlled trial will involve 100 women with a diagnosis of SUI. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Injury Due to Sling-shot
- What is being tested?
- Ophira and Transobturator sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Jul 2014
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years
- Clinical and urodynamic diagnosis of stress urinary incontinence
- Absence of associated neurological diseases
- No clinically significant detrusor instability (ie, to determine which symptoms are proportionally more significant for patient incontinence efforts)
Who cannot join
- urodynamic changes suggesting a reduction in bladder capacity, bladder compliance or suggestive of bladder outlet obstruction
- Coagulopathies
- Pregnancy
- History of sensitivity to foreign body
- Acute Urinary Tract Infection
- Sequelae of high exposure to ionizing radiation
Show all 9Show fewer
- Use of drugs that can result in high and / or risk of significant postoperative complications surgical risk, including any drug that interferes with blood clotting
- anesthetic contraindication to the procedure
- Vulvovaginitis: presence of vaginal discharge with laboratory proven infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial
- OBJECTIVE: To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence (SUI) treatment.
- METHODS:
This prospective single-center randomized controlled trial will involve 100 women with a diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form, operation time, complications, and reoperation rates were also recorded. The efficacy was analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P value >.05 rejects the noninferiority hypothesis of the mini-sling.
- Conditions
- Injury Due to Sling-shot
- Being tested
- Ophira, Transobturator sling
- Keywords
- stress incontinence, transobturator sling, single-incision mini-sling
- 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.
OphiraDevice
The procedure will be perfomed with a single incision in anterior wall vagina
Transobturator slingDevice
Also called Unitape T plus
Safyre T Plus ® system uses two helical needles for securing an average urethral sling mesh polypropylene soft tissue below the pubic bone by means of spinal anesthesia. Short form of the sling implantation is carried out as follows: a small longitudinal incision in the anterior vaginal wall approximately 2 cm is performed at 1 cm from the urethral meatus. Takes place below minimum dissection toward the lower branch of the ischium, and with the aid of the needle obturator and perforated membrane (outside-in maneuver). After that, the sling is attached to the needle carrying the same path. Subsequently, the passage of the needle is held in contraleral side. The procedure finishes performing the adjustment of the track with the aid of Kelly forceps type.
| Study group | Role | What they receive |
|---|---|---|
| Single incision mini-sling | Experimental | Experimental group: surgery to treat stress urinary incontinence with the Ophira mini sling systemt® Receives: Device: Ophira |
| Transobturator sling | Active comparator | Control group: surgery to treat stress urinary incontinence with the Unitape T Plus®. Receives: Device: Transobturator sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the cure rates between the mini sling and classical transobturator tapes
Percentage of patients who are regarded as cured or improved based on the following criteria:
- Negative Cough Stress test 1 year after surgery
- Pad Test < 2 g 1 year after surgery
Measured: Up to one year
Secondary outcomes (1)
Number of participants with adverse events
Comparison of the intra- and postoperative complications between procedures
Measured: 0, 1, 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJul 2014
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 Injury Due to Sling-shotStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina do ABC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emerson Oliveira, Faculdade de Medicina do ABC
- Investigators
- EMERSON OLIVEIRA, PhD, Principal investigator, FACULTY OF MEDICINE OF ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540525
- Sponsor's protocol ID
- URO-2009
- Status last verified
- Sep 2015
- First submitted
- 22 Feb 2014
- Last updated
- 4 Sep 2015
- 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 37888839
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02540525
- Acronym / sponsor ID
- URO-2009
- Conditions
- Injury Due to Sling-shot
- Keywords
- stress incontinence, transobturator sling, single-incision mini-sling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Sep 2015 (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.
- OBJECTIVE: To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence (SUI) treatment.
- METHODS:
This prospective single-center randomized controlled trial will involve 100 women with a diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form, operation time, complications, and reoperation rates were also recorded. The efficacy was analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P value >.05 rejects the noninferiority hypothesis of the mini-sling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single incision mini-sling | Experimental | Device: OphiraExperimental group: surgery to treat stress urinary incontinence with the Ophira mini sling systemt® |
| Transobturator sling | Active comparator | Device: Transobturator slingControl group: surgery to treat stress urinary incontinence with the Unitape T Plus®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged over 18 years
- Clinical and urodynamic diagnosis of stress urinary incontinence
- Absence of associated neurological diseases
- No clinically significant detrusor instability (ie, to determine which symptoms are proportionally more significant for patient incontinence efforts)
Key exclusion criteria (9 listed)
- urodynamic changes suggesting a reduction in bladder capacity, bladder compliance or suggestive of bladder outlet obstruction
- Coagulopathies
- Pregnancy
- History of sensitivity to foreign body
- Acute Urinary Tract Infection
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 |
|---|---|---|
| OphiraThe procedure will be perfomed with a single incision in anterior wall vagina | Device | Single incision mini-sling |
| Transobturator slingAlso: Unitape T plusSafyre T Plus ® system uses two helical needles for securing an average urethral sling mesh polypropylene soft tissue below the pubic bone by means of spinal anesthesia. Short form of the sling implantation is carried out as follows: a small longitudinal incision in the anterior vaginal wall approximately 2 cm is performed at 1 cm from the urethral meatus. Takes place below minimum dissection toward the lower branch of the ischium, and with the aid of the needle obturator and perforated membrane (outside-in maneuver). After that, the sling is attached to the needle carrying the same path. Subsequently, the passage of the needle is held in contraleral side. The procedure finishes performing the adjustment of the track with the aid of Kelly forceps type. | Device | Transobturator sling |
Primary outcome
Comparison of the cure rates between the mini sling and classical transobturator tapes
Time frame: Up to one year
Percentage of patients who are regarded as cured or improved based on the following criteria: * Negative Cough Stress test 1 year after surgery * Pad Test < 2 g 1 year after surgery
1 secondary outcome
Number of participants with adverse events
Time frame: 0, 1, 6 and 12 months after surgery
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 4 Sep 2015.
- 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.
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.
EMERSON OLIVEIRA, PhD principal investigator
FACULTY OF MEDICINE OF ABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ophira and Transobturator sling in people with Injury Due to Sling-shot, run by Faculdade de Medicina do ABC 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 4 inclusion and 9 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 4 Sep 2015. 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.
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?
Comparison of the cure rates between the mini sling and classical transobturator tapes (time frame: Up to 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 NCT02540525, 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 4 Sep 2015.