NCT00521066已完成不适用
A Prospective, Multi-centre Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Pelvic Organ Prolapse
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 11
- 主要终点
- Success based on overall POP-Q score at 12 months post-procedure.
研究概览
简要总结
The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP.
(*TRADEMARK)
详细描述
The GYNECARE PROSIMA* system provides a simplified mesh repair, avoiding the need for dissection outside the pelvic cavity.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy, perineal repair and/or mid urethral sling procedures for incontinence may be performed concurrently.
- •Age ≥ 18 years.
- •Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee / IRB approved informed consent.
排除标准
- •Additional surgical intervention concurrent to the PROSIMA procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation).
- •Previous repair of pelvic organ prolapse involving insertion of mesh.
- •Previous hysterectomy within 6 months of scheduled surgery.
- •Experimental drug or experimental medical device within 3 months prior to the planned procedure.
- •Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
- •Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
- •History of chemotherapy or pelvic radiation therapy.
- •Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).
- •Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
- •Nursing or pregnant or intends future pregnancy.
- •In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
结局指标
主要结局
Success based on overall POP-Q score at 12 months post-procedure.
时间窗: 12-months
Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP.
次要结局
- Mean change from baseline in UIQ score(24 months)
- EuroQol (EQ-5D health state) change from baseline(24 months)
- Mean change from baseline in PISQ-12 score(24 months)
- Success based on treated compartment ICS POP-Q stage(24 months)
- Mean PFDI-20 score(24 months)
- Mean change from baseline in PFDI-20 scores(12 months)
- Mean change from baseline in POPDI score(24 months)
- Mean change from baseline in CRADI score(24 months)
- Mean CRAIQ score(24 months)
- Mean PISQ-12 score(24 months)
- Mean POPIQ score(24 months)
- Discomfort of balloon removal, measured using VAS at time of removal.(24 hrs post-surgical)
- Subject perception of VSD: Awareness(3-4 week visit)
- Success based on overall POP-Q score at 24 months post-procedure.(24 months)
- Success defined as the leading edge within the hymen(24 months)
- Mean change from baseline in CRAIQ score(24 months)
- Mean UIQ score(24 months)
- Mean POPDI score(24 months)
- Mean UDI score(24 months)
- Mean change from baseline in UDI score(24 months)
- Mean PFIQ-7 score(24 months)
- Mean change from baseline in PFIQ-7 score(24 months)
- Subject perception of VSD: Discomfort(3-4 week visit)
- Mean CRADI score(24 months)
- Mean change from baseline in POPIQ score(24 months)
- Pain score measured using Visual Analog Scale (VAS).(24 hours post surgery and at the 3-4 week visit)
- Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia(ongoing)
- Length of procedure(perioperative)
- Subject perception of VSD: Acceptability of discharge(3-4 week visit)
- Subject global impression(24 month visit)
研究者
研究点 (11)
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