NCT04829994进行中（未招募）不适用
A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT EXACT® Continence System for the Treatment of Stress Urinary Incontinence
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 198
- 试验地点
- 13
- 主要终点
- Cough Stress Test (CST) Assessment Change
研究概览
简要总结
The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
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
- •Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
- •Stress urinary incontinence symptoms
- •Stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test
- •Female subjects ≥ 21 years of age requiring treatment of SUI
- •Desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling
- •Planned surgery for primary stress incontinence without concomitant prolapse surgery
- •Patient able and willing to participate in follow-up
- •Subject or authorized representative has signed the approved informed consent
排除标准
- •Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:
- •Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study 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 study product
- •History of previous synthetic, biologic or fascial pubo-urethral sling
- •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)
- •Contraindication to surgery
结局指标
主要结局
Cough Stress Test (CST) Assessment Change
时间窗: Post-surgery through study completion, approximately 5-10 yrs
Objective cure of Stress Urinary Incontinence (SUI) (treatment success) sproximately 5-10 years after surgery, defined as a negative CST
次要结局
- Patient Global Impression of Improvement (PGI-I)(Post-surgery through study completion, approximately 10 yrs)
- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)(Baseline and post-surgery through study completion, approximately 10 yrs)
- Wong-Baker FACES® Pain Rating Scale(Post-surgery through study completion, approximately 10 yrs)
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)(Baseline and post-surgery through study, approximately 10 yrs completion)
研究者
研究点 (13)
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