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

Bartin State Hospital64 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Urinary Incontinence,Stress

Interventions

Pelvic floor ultrasoundDIAGNOSTIC_TEST

Pelvic floor ultrasound will include transperineal and introital ultrasound

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Bartin State Hospital

Bartın, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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