APAS Study: Pragmatic Evaluation of the Performance and Safety of the Anchorsure System® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women. A Post-market Multicentre Prospective Observational Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Successful performance after sacrospinous fixation of the Anchorsure System®.
研究概览
简要总结
Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most common types of prolapse. Treatment for apical prolapse ranges from observation, non-surgical treatment or surgical repair. An anchoring device can reduce dissection and operative time and is meant to provide strong fixation whilst minimizing potential postoperative pain by avoiding neurovascular injuries. These potential advantages must be evaluated in terms of performance and safety. This cohort study will be on patients undergoing sacrospinous fixation with the Anchorsure® system with a follow-up of 36 months.
详细描述
Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most frequent. Treatment options for women with apical prolapse range from observation, non-surgical treatment or surgical repair. The use of an anchoring device reduces dissection and operative time and is supposed to provide a strong fixation while minimizing potential postoperative pain by avoiding neurovascular injuries. These potential advantages have to be evaluated in terms of performance and safety. This is a cohort study on patients undergoing sacrospinous fixation with the Anchorsure® system with a follow-up of 36 months.The primary objective of the study is to evaluate the performance of the Anchorsure System® for sacrospinous suspension 12 months after surgical treatment of women with apical prolapse in real-life settings.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with pelvic organ prolapse with leading edge at or beyond the hymen as confirmed by the pelvic organ prolapse quantification system (POP-Q), i.e. Ba ≥ -1 cm for the anterior compartment, and/or Bp ≥ -1 cm for the posterior compartment, and/or C ≥ -1 cm for the apical compartment including recurrence.
- •Women due for POP surgery using the Anchorsure System® for apical prolapse suspension with or without concomitant native tissue repair, with or without concomitant hysterectomy and with or without concomitant sling for stress urinary incontinence.
- •All women who have not indicated any objection to participating in the study.
- •All women who have been correctly informed.
排除标准
- •Patient taking part or having taken part in a device or drug interventional study within the last three months (except for VIGI-MESH national registry).
- •Patients due for pelvic organ prolapse repair without apical suspension or with anything other than native tissue repair and the Anchorsure System®.
- •Patients with uncontrolled diabetes mellitus.
- •Patients with active non-controlled or chronic gynaecologic or urinary tract infection and/or local tissue necrosis.
- •Patients with ongoing pelvic organ cancer (e.g. uterine, ovarian, bladder, cervix …).
- •Patients with a history of radiotherapy in the pelvic area.
- •Patients on therapy with immunosuppressive or immunomodulatory treatment within the previous month.
- •patients under ongoing oral anticoagulant therapy.
- •Patients with stage 0 and 1 pelvic organ prolapse at the time of surgery
- •Patients with a preoperative infection contraindicating the surgery
结局指标
主要结局
Successful performance after sacrospinous fixation of the Anchorsure System®.
时间窗: 12 months after fixation
YES /NO
次要结局
- Device or procedure-related adverse events: Daily Pain score(Day 0 to Day 30)
- Device or procedure-related adverse events: Anchor palpability(36 months after surgery)
- Device or procedure-related adverse events: Abnormal findings on clinical examination(36 months after surgery)
- Type of sacrospinous fixation technique used(Day 0)
- Success of the intervention(36 months after surgery)
- Complications/adverse events(36 months after surgery)
- Severity of adverse events(36 months after surgery)
- Compartments treated(36 months after surgery)
- Potential risk factors for the success/failure of the treatment at baseline: Age(Day 0)
- Potential risk factors for the success/failure of the treatment at baseline: Body Mass Index(Day 0)
- Potential risk factors for the success/failure of the treatment at baseline: Previous history of pelvic surgery(Day 0)
- Potential risk factors for the success/failure of the treatment at baseline: Chronic constipation(Day 0)
- Potential risk factors for the success/failure of the treatment at baseline: Chronic pulmonary conditions(Day 0)
- Potential risk factors for the success/failure of the treatment at baseline: Vaginal compartment(Day 0)
- Potential risk factors for the success/failure of the treatment at baseline: Type of prolapse(Day 0)
- Potential risk factors for the success/failure of the treatment at baseline: Pelvic organ Prolapse Q grade(Day 0)
- Potential risk factors for the success/failure of the treatment at baseline: Concomitant surgery(Day 0)
- Potential risk factors for the occurrence of complications: Age(Day 0)
- Potential risk factors for the occurrence of complications: Body Mass Index(Day 0)
- Potential risk factors for the occurrence of complications: Smoking.(Day 0)
- Potential risk factors for the occurrence of complications: Sexual intercourse.(Day 0)
- Potential risk factors for the occurrence of complications: concomitant surgery(Day 0)
- Evolution of the PFDI-20 quality of life score(Up to 36 months after surgery.)
- Evolution of quality of life scores : PFIQ-7(Up to 36 months after surgery.)
- Evolution of quality of life scores : PISQ-IR(Up to 36 months after surgery.)
- Patient satisfaction(Up to 36 months after surgery.)
- Global impression of improvement (PGI-I)(Up to 36 months after surgery)
- Frequency of revision and/or surgical re-intervention(Up to 36 months)