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Clinical Trials/NCT03763097
NCT03763097
Completed
Not Applicable

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

Bartin State Hospital1 site in 1 country64 target enrollmentNovember 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence,Stress
Sponsor
Bartin State Hospital
Enrollment
64
Locations
1
Primary Endpoint
The correlation of failure with the sonographic features of the mesh
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
November 26, 2018
End Date
April 21, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Bartin State Hospital
Responsible Party
Principal Investigator
Principal Investigator

Murat Yassa

Principal Investigator

Bartin State Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • POP-Q(Evaluation at postoperative 1st and 4th weeks and preoperatively)
  • Nocturia(Evaluation at postoperative 1st and 4th weeks and preoperatively)
  • Subjective success(Evaluation at postoperative 1st and 4th weeks)
  • Anterior compartment mobility angles(Evaluation at postoperative 1st and 4th weeks and preoperatively)
  • Urge symptoms(Evaluation at postoperative 1st and 4th weeks and preoperatively)
  • Anterior compartment mobility distances(Evaluation at postoperative 1st and 4th weeks and preoperatively)

Study Sites (1)

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