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

NCT03763097 | Completed

• 1 other identifier: Ba2018-4
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence,Stress

Keywords

pelvic floor ultrasonography; transperineal ultrasound; introital ultrasound; mini-sling; needleless; Urinary Incontinence,Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Nocturia

  Evaluation at postoperative 1st and 4th weeks and preoperatively

• Urge symptoms

  Evaluation at postoperative 1st and 4th weeks and preoperatively

• Subjective success

  Evaluation at postoperative 1st and 4th weeks

• POP-Q

  Evaluation at postoperative 1st and 4th weeks and preoperatively

• Anterior compartment mobility distances

  Evaluation at postoperative 1st and 4th weeks and preoperatively

Study Arms (1)

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

Interventions

Pelvic floor ultrasound DIAGNOSTIC_TEST

Pelvic floor ultrasound will include transperineal and introital ultrasound

participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bartin State Hospital: lead

Study Sites (1)

Bartin State Hospital

Bartın, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 29549394 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

• Murat Yassa, MD

  Bartin State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2018
• First Posted: December 4, 2018
• Study Start: November 26, 2018
• Primary Completion: April 21, 2019
• Study Completion: April 21, 2019
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

TU (1)