Urinary Incontinence, StressNCT02506309
Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence
A study testing TOT - inside-out trans-obturator tape/sling and SIS - Innovative fixation single incision sling in people with Urinary Incontinence, Stress, run by Brno University Hospital.
Trial summary
Mid-urethral slings (MUS) now represent a gold standard in the treatment of female stress urinary incontinence (SUI). Second generation trans-obturator slings (TOT) have proven to be as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- TOT - inside-out trans-obturator tape/sling and SIS - Innovative fixation single incision sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with pure or predominant urodynamic stress urinary incontinence confirmed during filling cystometry by positive standardized cough stress test (CST) with urinary bladder filling of 250 ml in lithotomy position.
Who cannot join
- patients with predominant urge incontinence
- patients with intrinsic sphincter deficiency (MUCP<20 cmH2O)
- pelvic organ prolapse (POP-Q>2)
- previous urinary incontinence surgery
- previous pelvic organ prolapse surgery
- presence of other pelvic organ pathology.
About this study
Official title: Prospective Randomized Comparison of the Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence
Mid-urethral slings (MUS) now represent a gold standard in the treatment of female stress urinary incontinence (SUI). Second generation trans-obturator slings (TOT) have proven to be as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. A third generation of the MUS inserted through a single vaginal incision (SIS) has become a means to overcome significant post-operative groin pain. Novel types of SIS with a more robust and adjustable anchoring mechanism can assure adequate long-lasting attachment to the obturator membrane (OM). Objective of this study was to compare an inside-out TOT with an innovative fixation SIS in randomized controlled trial on patients undergoing their primary surgery for urodynamic SUI.
Read the detailed description
Objective of this study was to compare an inside-out TOT (Gynecare TVT Obturator System, Ethicon) with an innovative fixation SIS (Ophira, Promedon) in randomized controlled trial on patients undergoing their primary surgery for urodynamic SUI.
A prospective randomized controlled trial (RCT) is performed in one tertiary referral urogynecology center from January 2015 thru December 2015. Study included women with pure or predominant urodynamic SUI confirmed during cystometry by positive standardized cough stress test (CST) with urinary bladder filling of 250 ml in lithotomy position. Study was carried out on a Caucasian Czech (central European) population. A study power analysis was calculated with an expected objective cure rate of minimum 80 % for both patient groups, false non-match rate (alpha) of 0.05, and false match rate (beta) of 0.10. A minimum sample size of 80 patients was required for each group.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- TOT - inside-out trans-obturator tape/sling, SIS - Innovative fixation single incision 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.
TOT - inside-out trans-obturator tape/slingDevice
Also called Gynecare TVT Obturator System (Ethicon)
Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)
SIS - Innovative fixation single incision slingDevice
Also called Ophira (Promedon)
Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)
| Study group | Role | What they receive |
|---|---|---|
| SIS single incision sling | Experimental | SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI). Receives: Device: SIS - Innovative fixation single incision sling |
| TOT trans obturator tape/sling | Active comparator | TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI). Receives: Device: TOT - inside-out trans-obturator tape/sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Negative Cough Stress Test (CST)
Negative cough stress test four years after incontinence surgery.
Measured: four years
Patient Global Impression of Improvement (PGI-I) Score
Patient Global Impression of Improvement (PGI-I) score four years after incontinence surgery. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians
- Very much better
- Much better
- A little better
- No change
- A little worse
- Much worse
- Very much worse
Measured: four years
Secondary outcomes (2)
Number of Participants With Major Perioperative Complications
Measured: one month
Number of Participants With Major Postoperative Complications
Measured: four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence, StressStudies 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
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Huser, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506309
- Sponsor's protocol ID
- BrnoUH
- Status last verified
- Feb 2020
- First submitted
- 21 Jul 2015
- Last updated
- 18 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ogah J, Cody DJ, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women: a short version Cochrane review. Neurourol Urodyn. 2011 Mar;30(3):284-91. doi: 10.1002/nau.20980.
PubMed 21412819Nambiar A, Cody JD, Jeffery ST. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2014 Jun 1;(6):CD008709. doi: 10.1002/14651858.CD008709.pub2.
PubMed 24880654Carter 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 37888839Huser M, Hudecek R, Belkov I, Horvath I, Jarkovsky J, Tvarozek S. Safety and Efficacy of Single Incision Sling Versus Midurethral Sling in the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial. Urogynecology (Phila). 2023 Feb 1;29(2):113-120. doi: 10.1097/SPV.0000000000001284.
PubMed 36735422
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of the Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02506309
- Acronym / sponsor ID
- BrnoUH
- Conditions
- Urinary Incontinence, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Posted 5 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mid-urethral slings (MUS) now represent a gold standard in the treatment of female stress urinary incontinence (SUI). Second generation trans-obturator slings (TOT) have proven to be as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. A third generation of the MUS inserted through a single vaginal incision (SIS) has become a means to overcome significant post-operative groin pain. Novel types of SIS with a more robust and adjustable anchoring mechanism can assure adequate long-lasting attachment to the obturator membrane (OM). Objective of this study was to compare an inside-out TOT with an innovative fixation SIS in randomized controlled trial on patients undergoing their primary surgery for urodynamic SUI.
Detailed description
Objective of this study was to compare an inside-out TOT (Gynecare TVT Obturator System, Ethicon) with an innovative fixation SIS (Ophira, Promedon) in randomized controlled trial on patients undergoing their primary surgery for urodynamic SUI.
A prospective randomized controlled trial (RCT) is performed in one tertiary referral urogynecology center from January 2015 thru December 2015. Study included women with pure or predominant urodynamic SUI confirmed during cystometry by positive standardized cough stress test (CST) with urinary bladder filling of 250 ml in lithotomy position. Study was carried out on a Caucasian Czech (central European) population. A study power analysis was calculated with an expected objective cure rate of minimum 80 % for both patient groups, false non-match rate (alpha) of 0.05, and false match rate (beta) of 0.10. A minimum sample size of 80 patients was required for each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIS single incision sling | Experimental | Device: SIS - Innovative fixation single incision slingSIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI). |
| TOT trans obturator tape/sling | Active comparator | Device: TOT - inside-out trans-obturator tape/slingTOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI). |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with pure or predominant urodynamic stress urinary incontinence confirmed during filling cystometry by positive standardized cough stress test (CST) with urinary bladder filling of 250 ml in lithotomy position.
Key exclusion criteria (6 listed)
- patients with predominant urge incontinence
- patients with intrinsic sphincter deficiency (MUCP<20 cmH2O)
- pelvic organ prolapse (POP-Q>2)
- previous urinary incontinence surgery
- previous pelvic organ prolapse surgery
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 |
|---|---|---|
| TOT - inside-out trans-obturator tape/slingAlso: Gynecare TVT Obturator System (Ethicon)Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS) | Device | TOT trans obturator tape/sling |
| SIS - Innovative fixation single incision slingAlso: Ophira (Promedon)Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS) | Device | SIS single incision sling |
Primary outcome
Percentage of Participants With Negative Cough Stress Test (CST)
Time frame: four years
Negative cough stress test four years after incontinence surgery.
Patient Global Impression of Improvement (PGI-I) Score
Time frame: four years
Patient Global Impression of Improvement (PGI-I) score four years after incontinence surgery. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians 1. Very much better 2. Much better 3. A little better 4. No change 5. A little worse 6. Much worse 7. Very much worse
2 secondary outcomes
Number of Participants With Major Perioperative Complications
Time frame: one month
Number of Participants With Major Postoperative Complications
Time frame: four years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21412819Ogah J, Cody DJ, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women: a short version Cochrane review. Neurourol Urodyn. 2011 Mar;30(3):284-91. doi: 10.1002/nau.20980.
- Background: PubMed 24880654Nambiar A, Cody JD, Jeffery ST. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2014 Jun 1;(6):CD008709. doi: 10.1002/14651858.CD008709.pub2.
- 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 36735422Huser M, Hudecek R, Belkov I, Horvath I, Jarkovsky J, Tvarozek S. Safety and Efficacy of Single Incision Sling Versus Midurethral Sling in the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial. Urogynecology (Phila). 2023 Feb 1;29(2):113-120. doi: 10.1097/SPV.0000000000001284.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TOT - inside-out trans-obturator tape/sling and SIS - Innovative fixation single incision sling in people with Urinary Incontinence, Stress, run by Brno University Hospital.
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: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 5 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Negative Cough Stress Test (CST) (time frame: four years). The study lists 2 primary outcomes in all. 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 NCT02506309, which also lists 4 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 18 Feb 2020.