Urinary Incontinence,StressNCT03763097
Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success
An observational study of Urinary Incontinence,Stress, run by Bartin State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Transperineal ultrasonography is gaining importance in preoperative and postoperative evaluation of the patient with urinary incontinence with allowing well detailed information about the anterior compartment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence,Stress
- What is being tested?
- Pelvic floor ultrasound
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Nov 2018to 21 Apr 2019
- Phase
- Observational
- 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
Study population: Patients who have stress urinary incontinence and who are scheduled for needleless mini-sling operation.
Who may be able to join
- Patients with clinically stress urinary incontinence
- Patients who claim that their condition severely impair their quality of life
- Patients who are failed on conservative management (life style changes and pelvic floor exercises)
Who cannot join
- Patients who have unregulated diabetes mellitus (they will be included after appropriate and sustainable blood glucose regulation)
- Patients who have neurological condition that may affect the incontinence
- Patients who have psychiatric disease that may affect the subjective evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Transperineal ultrasonography is gaining importance in preoperative and postoperative evaluation of the patient with urinary incontinence with allowing well detailed information about the anterior compartment.
There is little evidence that transperineal sonography can aid surgeons to predict the success or failure after mid-urethral slings.
We aimed to investigate the efficacy of sonography in mini-sling operations to predict the success or failure.
Read the detailed description
Women who are scheduled for anti-incontinence operation due to their stress urinary incontinence will be pre- and postoperatively evaluated by transperineal and introital ultrasound.
Patients will be followed for at least 1 year.
- Conditions
- Urinary Incontinence,Stress
- Being tested
- Pelvic floor ultrasound
- Keywords
- pelvic floor ultrasonography, transperineal ultrasound, introital ultrasound, mini-sling, needleless, Urinary Incontinence,Stress
- 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.
Pelvic floor ultrasoundDiagnostic test
Pelvic floor ultrasound will include transperineal and introital ultrasound
| Study group | Role | What they receive |
|---|---|---|
| participants | Patients who are scheduled for single-incision needleless (Contasure-needleless®) mini-sling for their stress urinary incontinence. They will be assessed by Pelvic floor ultrasound Receives: Diagnostic Test: Pelvic floor ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation of failure with the sonographic features of the mesh
Patients will be accepted as failure if their stress test is positive Sonographic features of the mesh includes the shape of the mesh, the distance to the mid-urethra, the position related to the proximal urethra and the angle between the mesh arms on coronal axis
Measured: Evaluation at postoperative 1st and 4th weeks
Secondary outcomes (6)
Nocturia
The nocturia episodes will be evaluated by a "non-validated" Likert scale (between 0-3). Minimum and minimum scores are between 0 and 3. "0" will mean no episode of urinating during the sleep. "1" will mean one episode of nocturia. "2" will mean two episodes of nocturia. "3" will mean three or more episodes of nocturia. Higher values represent worse outcome.
Measured: Evaluation at postoperative 1st and 4th weeks and preoperatively
Urge symptoms
Michigan Incontinence Severity Index (M-ISI) scale will be used to assess subjective outcome including urge symptoms. This scale has ten items, consisting of a total M-ISI domain (the sum of items 1-8) and a distinct Bother domain (the sum of items 9 and 10). The total M-ISI score consists of three subdomains (items 1-3 for stress urinary incontinence [SUI], items 4-6 for urge urinary incontinence [UUI], and items 7 and 8 for Pad usage [PU]. The responses for each item range from 0 to 4 on a Likert-type scale, with higher values representing greater symptoms and greater bother. Total domain and subdomain scores are obtained by simply adding the respective answers. The minimally important difference has been determined for the following domains/subdomains: total M-ISI (4 points), SUI (2 points), UUI (2 points), and PU (1 point).
Measured: Evaluation at postoperative 1st and 4th weeks and preoperatively
Subjective success
Patient Global Improvement of Improvement will be used to assess the subjective success
Measured: Evaluation at postoperative 1st and 4th weeks
POP-Q
POP-Q measurements will be assessed to measure the pelvic floor prolapse if exist
Measured: Evaluation at postoperative 1st and 4th weeks and preoperatively
Anterior compartment mobility distances
On maximal Valsalva maneuver: Bladder neck descent (mm), pubourethral distance (mm), urethral thickness (mm, measured at proximal, mid and distal portions) and urethral length (mm)
Measured: Evaluation at postoperative 1st and 4th weeks and preoperatively
Anterior compartment mobility angles
On maximal Valsalva maneuver: Proximal urethral rotation (degree), retrovesical angle (degree)
Measured: Evaluation at postoperative 1st and 4th weeks and preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start26 Nov 2018
- Primary completion21 Apr 2019
- Study completion21 Apr 2019
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartin State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Murat Yassa, Bartin State Hospital
- Investigators
- Murat Yassa, MD, Principal investigator, Bartin State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763097
- Sponsor's protocol ID
- Ba2018-4
- Status last verified
- Apr 2019
- First submitted
- 24 Nov 2018
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dogan O, Kaya AE, Pulatoglu C, Basbug A, Yassa M. A randomized comparison of a single-incision needleless (Contasure-needleless(R)) mini-sling versus an inside-out transobturator (Contasure-KIM(R)) mid-urethral sling in women with stress urinary incontinence: 24-month follow-up results. Int Urogynecol J. 2018 Sep;29(9):1387-1395. doi: 10.1007/s00192-018-3624-4. Epub 2018 Mar 16.
PubMed 29549394
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success
- ClinicalTrials.gov ID
- NCT03763097
- Acronym / sponsor ID
- Ba2018-4
- Conditions
- Urinary Incontinence,Stress
- Keywords
- pelvic floor ultrasonography, transperineal ultrasound, introital ultrasound, mini-sling, needleless, Urinary Incontinence,Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bartin State HospitalOther government
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 21 Apr 2019 (actual)
- Study completion
- 21 Apr 2019 (actual)
- First posted
- 4 Dec 2018 (actual)
- 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.
Transperineal ultrasonography is gaining importance in preoperative and postoperative evaluation of the patient with urinary incontinence with allowing well detailed information about the anterior compartment.
There is little evidence that transperineal sonography can aid surgeons to predict the success or failure after mid-urethral slings.
We aimed to investigate the efficacy of sonography in mini-sling operations to predict the success or failure.
Detailed description
Women who are scheduled for anti-incontinence operation due to their stress urinary incontinence will be pre- and postoperatively evaluated by transperineal and introital ultrasound.
Patients will be followed for at least 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants | – | Diagnostic Test: Pelvic floor ultrasoundPatients who are scheduled for single-incision needleless (Contasure-needleless®) mini-sling for their stress urinary incontinence. They will be assessed by Pelvic floor ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have stress urinary incontinence and who are scheduled for needleless mini-sling operation.
Key inclusion criteria (3 listed)
- Patients with clinically stress urinary incontinence
- Patients who claim that their condition severely impair their quality of life
- Patients who are failed on conservative management (life style changes and pelvic floor exercises)
Key exclusion criteria (3 listed)
- Patients who have unregulated diabetes mellitus (they will be included after appropriate and sustainable blood glucose regulation)
- Patients who have neurological condition that may affect the incontinence
- Patients who have psychiatric disease that may affect the subjective evaluation.
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 |
|---|---|---|
| Pelvic floor ultrasoundPelvic floor ultrasound will include transperineal and introital ultrasound | Diagnostic test | participants |
Primary outcome
The correlation of failure with the sonographic features of the mesh
Time frame: Evaluation at postoperative 1st and 4th weeks
Patients will be accepted as failure if their stress test is positive Sonographic features of the mesh includes the shape of the mesh, the distance to the mid-urethra, the position related to the proximal urethra and the angle between the mesh arms on coronal axis
6 secondary outcomes
Nocturia
Time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively
Urge symptoms
Time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively
Subjective success
Time frame: Evaluation at postoperative 1st and 4th weeks
POP-Q
Time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively
Anterior compartment mobility distances
Time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively
Anterior compartment mobility angles
Time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively
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 23 Apr 2019.
- Background: PubMed 29549394Dogan O, Kaya AE, Pulatoglu C, Basbug A, Yassa M. A randomized comparison of a single-incision needleless (Contasure-needleless(R)) mini-sling versus an inside-out transobturator (Contasure-KIM(R)) mid-urethral sling in women with stress urinary incontinence: 24-month follow-up results. Int Urogynecol J. 2018 Sep;29(9):1387-1395. doi: 10.1007/s00192-018-3624-4. Epub 2018 Mar 16.
- Individual participant dataSharing planned: Undecided
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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.
Murat Yassa, MD principal investigator
Bartin State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence,Stress, run by Bartin State Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 23 Apr 2019. 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 Turkey (Türkiye). 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?
The correlation of failure with the sonographic features of the mesh (time frame: Evaluation at postoperative 1st and 4th weeks). 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 NCT03763097, 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 23 Apr 2019.