NCT02049840已完成不适用
The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 26
- 主要终点
- Proportion of subjects who meet the criteria of cure at 12 months
研究概览
简要总结
This is a prospective, post-market, single arm, multicenter study comparing Baseline data to the 12 month and 36 month data in 136 female patients with Stress Urinary Incontinence
详细描述
This study is a prospective, European Post-Market, one non-controlled arm, multi-centre clinical trial conducted at up to 10 centers in Europe. It is designed to get more clinical information for users (uro-gynecologists) of the Altis Single Incision Sling System for female stress urinary incontinence treatment in terms of objective and subjective cure rate, quality of life improvement, patient satisfaction and safety, especially in long term follow-up (3 years). Clinical data will be collected at baseline, implantation procedure, post-operative at 6 weeks, 6 months, 1, 2 and 3 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The subject is female at least 18 years of age
- •The subject uses a method of contraception considered effective by the investigator or is not of child-bearing potential
- •The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.
- •The subject has confirmed stress urinary incontinence (SUI) through cough stress test at baseline.
- •The subject has failed first line treatments (non-invasive therapies, eg. behavioral modification, Pelvic Floor/Kegel exercises, or biofeedback) with good compliance for the treatment
排除标准
- •The subject had a prior surgical SUI treatment (including bulking agent).
- •The subject is having a concomitant Pelvic Organ Prolapse repair or hysterectomy during Altis procedure.
- •The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions).
- •The subject has predominant or uncontrolled or primary urge incontinence according to investigator judgment
- •The patient has detrusor overactivity determined through urodynamics
- •The subject has intrinsic sphincter deficiency defined urodynamically as a Maximal Urethral Closure Pressure < 20 cm H2O and/or Valsalva Leak Point Pressure < 60 cm H2O
- •The subject has atonic bladder, a persistent post void residual (PVR) > 100 ml or chronic urinary retention.
- •The subject has untreated urinary malignancy
- •The subject has undergone radiation or brachy therapy or chemotherapy to treat pelvic cancer.
- •The subject has urethrovaginal fistula or urethral diverticulum or congenital urinary anomalies
- •The subject has serious bleeding disorder or requires anticoagulant therapy
- •The subject is pregnant and/or is planning to get pregnant in the future.
- •The subject has a Body Mass Index ≥ 35 (obese class II).
- •The subject has a contraindication to the surgical procedure according to the the Altis SIS System IFU.
- •The subject has an active urogenital infection or active skin infection in region of surgery mainly at the time of implantation.
- •The subject is enrolled in a concomitant clinical trial.
结局指标
主要结局
Proportion of subjects who meet the criteria of cure at 12 months
时间窗: 1 year
Cure is defined as negative Cough Stress Test (CST) and an answer "no" to question 3 "Do you usually experience urine leakage related to coughing, sneezing, or laughing?" of the UDI-6 questionnaire
次要结局
- Postoperatively subject impression of improvement (via PGI-I questionnaire) and satisfaction at each post-operative visit(6 weeks, 6 months, 1 year, 2 year, 3 year)
- Proportion of subjects who have a negative cough stress test at each visit(6 weeks, 6 months, 1 year, 2 year, 3 year)
- Assessment of the operation duration and the type of anaesthesia used(Operative period)
- Assessment of device and procedure related adverse events(Operative period, 6 weeks, 6 months, 1 year, 2 year, 3 year)
- Assessment of postoperative pain(operative period, 6 weeks, 6 months, 1 year)
- Subject continence status measured by the 24-hour pad weight(6 weeks, 1 year)
- Proportion of subjects who meet the criteria of cure at each other visit(6 weeks, 6 months, 2 year, 3 year)
- Assessment of Qmax variations(6 weeks, 1year)
- Assessment of PVR variations(6 weeks, 1 year)
- Assessment of self reported symptoms and subject QoL through the scoring of validated questionnaires: ICIQ-UI SF, I-QOL, UDI-6 and IIQ-7(6 weeks, 6 months, 1 year, 2 year, 3 year)
研究者
研究点 (26)
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