Skip to main content
OpenTrials
Completed

NCT Number: NCT03763097

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Incontinence,Stress Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Bartin State Hospital

Bartın, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pelvic Floor Ultrasound

Diagnostic Test

Pelvic floor ultrasound will include transperineal and introital ultrasound

Primary outcomes

  1. 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

  1. Nocturia

    Time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively

    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.

  2. Urge symptoms

    Time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively

    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).

  3. Subjective success

    Time frame: Evaluation at postoperative 1st and 4th weeks

    Patient Global Improvement of Improvement will be used to assess the subjective success

  4. POP-Q

    Time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively

    POP-Q measurements will be assessed to measure the pelvic floor prolapse if exist

  5. Anterior compartment mobility distances

    Time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively

    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)

  6. Anterior compartment mobility angles

    Time frame: Evaluation at postoperative 1st and 4th weeks and preoperatively

    On maximal Valsalva maneuver: Proximal urethral rotation (degree), retrovesical angle (degree)

Sponsors and collaborators

Lead sponsor

Bartin State Hospital

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2018
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.