NCT04829175招募中不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 18
- 主要终点
- Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry:
- •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
- •Urodynamic testing (optional)
- •Female patient ≥ 21 years of age
- •Desired surgical correction of POP using synthetic mesh
- •Planned surgery for uterine or vaginal vault prolapse with or without concomitant SUI surgery
- •Patient able and willing to participate in follow-up
- •Patient or authorized representative has signed the approved Informed consent
排除标准
- •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
结局指标
主要结局
Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change
时间窗: Post-surgery through registry completion, approximately 5-10 yrs
Objective cure (success) approximately 5-10 years after surgery, defined as a negative standardized cough stress test (CST)
Pelvic Organ Prolapse (POP)- Physical Examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment Change
时间窗: Post-surgery through registry completion, approximately 5-10 yrs
Objective cure (success) approximately 5-10 years after surgery, defined as the absence of prolapse beyond the hymen as determined by a physical examination with POP-Q
次要结局
- POP: Patient Global Impression of Improvement questionnaire (PGI-I)(Post-surgery through registry completion, approximately 10 yrs)
- SUI: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)(Baseline and post-surgery through registry completion, approximately 10 yrs)
- SUI: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)(Baseline and post-surgery through registry completion, approximately 10 yrs)
- SUI: Patient Global Impression of Improvement questionnaire (PGI-I)(Post-surgery through registry completion, approximately 10 yrs)
- SUI: Wong-Baker FACES Pain Rating Scale(Post-surgery through registry completion, approximately 10 yrs)
- POP: Pelvic Floor Distress Inventory (PFDI-20) Questionnaire(Baseline and post-surgery through registry completion, approximately 10 yrs)
- POP: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)(Baseline and post-surgery through registry completion, approximately 10 yrs)
- POP: Wong-Baker FACES Pain Rating Scale(Post-surgery through registry completion, approximately 10 yrs)
研究者
研究点 (18)
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