Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success

Urinary Incontinence,Stress Clinical Trial

Official title:

Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763097
• Other study ID #: Ba2018-4
• Status: Completed
• Start date: November 26, 2018
• Est. completion date: April 21, 2019

Study information

• Verified date: April 2019
• Source: Bartin State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 21, 2019
• Est. primary completion date: April 21, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

Diagnostic Test:
• Pelvic floor ultrasound
Pelvic floor ultrasound will include transperineal and introital ultrasound

Locations

Country	Name	City	State
Turkey	Bartin State Hospital	Bartin

Sponsors (1)

Lead Sponsor	Collaborator
Bartin State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Dogan O, Kaya AE, Pulatoglu C, Basbug A, Yassa M. A randomized comparison of a single-incision needleless (Contasure-needleless®) mini-sling versus an inside-out transobturator (Contasure-KIM®) 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation at postoperative 1st and 4th weeks
Secondary	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.	Evaluation at postoperative 1st and 4th weeks and preoperatively
Secondary	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).	Evaluation at postoperative 1st and 4th weeks and preoperatively
Secondary	Subjective success	Patient Global Improvement of Improvement will be used to assess the subjective success	Evaluation at postoperative 1st and 4th weeks
Secondary	POP-Q	POP-Q measurements will be assessed to measure the pelvic floor prolapse if exist	Evaluation at postoperative 1st and 4th weeks and preoperatively
Secondary	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)	Evaluation at postoperative 1st and 4th weeks and preoperatively
Secondary	Anterior compartment mobility angles	On maximal Valsalva maneuver: Proximal urethral rotation (degree), retrovesical angle (degree)	Evaluation at postoperative 1st and 4th weeks and preoperatively