An observational study in Urinary Incontinence,Stress, sponsored by Bartin State Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by Bartin State Hospital · Observational
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.
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 64 is below the median of 120 across 305 observational studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Bartin State Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Patients who have stress urinary incontinence and who are scheduled for needleless mini-sling operation.
Exclusion Criteria:
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
Diagnostic Test: Pelvic floor ultrasound
Pelvic floor ultrasound will include transperineal and introital ultrasound
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
Time frame: Evaluation at postoperative 1st and 4th weeks
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.
Time frame: 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).
Time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively
Subjective success
Patient Global Improvement of Improvement will be used to assess the subjective success
Time frame: Evaluation at postoperative 1st and 4th weeks
POP-Q
POP-Q measurements will be assessed to measure the pelvic floor prolapse if exist
Time frame: 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)
Time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively
Anterior compartment mobility angles
On maximal Valsalva maneuver: Proximal urethral rotation (degree), retrovesical angle (degree)
Time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively
Plan to share: Undecided
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Bartin State Hospital