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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence,Stress
• Intervention / Treatment: Diagnostic test: Pelvic floor ultrasound

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.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Turkey
  • Bartin, Turkey
    • Bartin State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients who have stress urinary incontinence and who are scheduled for needleless mini-sling operation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
participants; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Subjective success	Patient Global Improvement of Improvement will be used to assess the subjective success	Evaluation at postoperative 1st and 4th weeks
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
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
Anterior compartment mobility angles	On maximal Valsalva maneuver: Proximal urethral rotation (degree), retrovesical angle (degree)	Evaluation at postoperative 1st and 4th weeks and preoperatively

Collaborators and Investigators

• Sponsor: Bartin State Hospital

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 26, 2018
• Primary Completion (ACTUAL): April 21, 2019
• Study Completion (ACTUAL): April 21, 2019

Study Registration Dates

• First Submitted: November 24, 2018
• First Submitted That Met QC Criteria: December 1, 2018
• First Posted (ACTUAL): December 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 21, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: transperineal ultrasound; pelvic floor ultrasonography; introital ultrasound; mini-sling; needleless; Urinary Incontinence,Stress
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: Ba2018-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No