Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

Официальное название

A Long Term Prospective Observational Post Market Clinical Follow-Up (PMCF) Registry of Ethicon Gynecare Pelvic Mesh Products for The Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

Обзор

The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP.

Вмешательства

• Устройство Intervention
  There is no intervention, beyond necessary clinical care, in this registry. The surgical procedures being performed within the registry are identical to the surgical procedures patients would receive as part of SOC.

Первичные конечные точки

• Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change [Срок оценки: Post-surgery through registry completion, approximately 5-10 yrs]
• Pelvic Organ Prolapse (POP)- Physical Examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment Change [Срок оценки: Post-surgery through registry completion, approximately 5-10 yrs]

Вторичные конечные точки (8)

• SUI: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) [Срок оценки: Baseline and post-surgery through registry completion, approximately 10 yrs]
• SUI: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) [Срок оценки: Baseline and post-surgery through registry completion, approximately 10 yrs]
• SUI: Patient Global Impression of Improvement questionnaire (PGI-I) [Срок оценки: Post-surgery through registry completion, approximately 10 yrs]
• SUI: Wong-Baker FACES Pain Rating Scale [Срок оценки: Post-surgery through registry completion, approximately 10 yrs]
• POP: Pelvic Floor Distress Inventory (PFDI-20) Questionnaire [Срок оценки: Baseline and post-surgery through registry completion, approximately 10 yrs]
• POP: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) [Срок оценки: Baseline and post-surgery through registry completion, approximately 10 yrs]
• POP: Patient Global Impression of Improvement questionnaire (PGI-I) [Срок оценки: Post-surgery through registry completion, approximately 10 yrs]
• POP: Wong-Baker FACES Pain Rating Scale [Срок оценки: Post-surgery through registry completion, approximately 10 yrs]

Критерии участия

Критерии включения

Patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry:

SUI

• Stress urinary incontinence symptoms
• Urodynamic stress incontinence confirmed with urodynamic testing
• Female patient ≥ 21 years of age
• Desired surgical correction of SUI using synthetic pubo-urethral vaginal sling
• Planned surgery for primary SUI
• Patient able and willing to participate in follow-up
• Patient or authorized representative has signed the approved Informed consent POP

1\. Uterine or vaginal vault prolapse symptoms 2. Urodynamic testing (optional) 3. Female patient ≥ 21 years of age 4. Desired surgical correction of POP using synthetic mesh 5. Planned surgery for uterine or vaginal vault prolapse with or without concomitant SUI surgery 6. Patient able and willing to participate in follow-up 7. Patient or authorized representative has signed the approved Informed consent

Критерии исключения

Patients meeting any of the following criteria will be considered not eligible for enrollment in this registry:

• Physical or psychological condition which would impair registry participation or are unwilling or unable to participate in all required registry visits and are unable to complete the questionnaires
• Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of registry products
• History of previous synthetic, biologic or fascial sub-urethral sling (SUI) or pelvic mesh (POP)
• Pregnancy or plans for future pregnancy
• History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice
• Current genitourinary fistula or urethral diverticulum
• Reversible cause of incontinence (i.e. drug effect) for SUI only
• Severe vaginal atrophy
• History of pelvic irradiation therapy
• Contraindication to surgery

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 4 центра

• Yale University — New Haven
• Duke University — Durham
• University of Pennsylvania — Philadelphia
• UPMC — Pittsburgh

Австрия · 1 центр

• Krankenhaus der barmherzigen Schwestern — Linz

Дания · 1 центр

• Herlev Hospital — Hillerød

Франция · 1 центр

• Hopital Jeanne de Flandres — Lille

Германия · 1 центр

• Universitatsklinikum Tubingen — Tübingen

Италия · 1 центр

• Bio-Medical University Rome — Rome

Швеция · 1 центр

• Karolinska Institute — Stockholm

Идентификаторы

NCT: NCT04829175 · ESC_2020_03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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