NCT03650244进行中（未招募）不适用
Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence
Centre Hospitalier Universitaire de Nīmes20 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年11月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 20
- 主要终点
- Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
研究概览
简要总结
We wish to set up a multicentric prospective observational study across France to collate data on the efficacy and tolerance of the Male REMEEX® device in patients with moderate stress urinary incontinence following radical prostatectomy. Patient satisfaction, improvement in quality of life, side effects and complications will also be studied, as will the ease of use of the device from the point of view of the surgeon. A long-term follow-up of 5 years will be conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient has been informed about the study
- •The patient is at least 18 years old
- •Patient suffering from moderate stress incontinence (pure or predominant) following radical prostatectomy surgery, for at least 12 months, unresolved after of pelvic floor reeducation
- •Patient scheduled for REMEEX® implant
排除标准
- •It proves impossible to give the patient clear information
- •Patient refuses to participate
- •Life expectancy of the patient estimated to be less than the 5 year follow-up
- •Impossible to contact patient after hospitalization
- •Radiotherapy of less than 6 month
- •Patient unable to fill in questionnaire
- •Incapably of performing pad test at 24 hours
- •Recurrent symptomatic prostate cancer
- •Mixed incontinence with urgency incontinence
- •Bladder outlet obstruction: stenosis of the vesico-urethral anastomosis or untreated urethral stricture.
- •Post void residual >100ml
- •Other cancer under treatment or progressing
- •Kidney injury, hepatocellular insufficiency
- •Auto-immune disease
- •Neurological-origin urinary incontinence (stroke, MS, Parkinson's)
- •Incontinence arising from surgery other than prostatectomy
- •recurrent gross hematuria
- •Recurrent urinary infection
- •Bladder stones
研究组 & 干预措施
Patients fitted with REMEEX
干预措施: REMEEX implantation (Device)
结局指标
主要结局
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
时间窗: 5 years
PAD test \< 2 g / 24 h
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
时间窗: 1 month
PAD test \< 2 g / 24 h
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
时间窗: 6 months
PAD test \< 2 g / 24 h
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
时间窗: 1 year
PAD test \< 2 g / 24 h
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
时间窗: 2 years
PAD test \< 2 g / 24 h
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
时间窗: 3 years
PAD test \< 2 g / 24 h
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
时间窗: 4 years
PAD test \< 2 g / 24 h
次要结局
- Normal clinical examination(Year 5)
- cystoscopy(year 5)
- urinary output(year 5)
- Volume of urine(year 5)
- Patient incontinence-related quality of life(5 years)
- Patient sexual-related quality of life(5 years)
- Post-void residual urine volume(year 5)
- readjustment of the REMEEX medical device(Year 5)
- Side effects or complications(5 years)
- Reliability and ease of use of the device(5 years)
- Satisfaction of use by the surgeon.(Day 0)
- General improvement of symptoms(5 years)
- Improvement of urinary symptoms(5 years)
- Normal clinical examination(month 1)
- Normal clinical examination(Month 6)
- Normal clinical examination(Year 1)
- Normal clinical examination(Year 2)
- Normal clinical examination(Year 3)
- Normal clinical examination(Year 4)
- urinary output(Month 1)
- urinary output(Month 6)
- urinary output(year 1)
- urinary output(year 2)
- urinary output(year 3)
- urinary output(year 4)
- Volume of urine(month 1)
- Volume of urine(month 6)
- Volume of urine(year 1)
- Volume of urine(year 2)
- Volume of urine(year 3)
- Volume of urine(year 4)
- Post-void residual urine volume(Month 1)
- Post-void residual urine volume(Month 6)
- Post-void residual urine volume(year 1)
- Post-void residual urine volume(year 2)
- Post-void residual urine volume(year 3)
- Post-void residual urine volume(year 4)
- cystoscopy(Month 1)
- cystoscopy(Month 6)
- cystoscopy(year 1)
- cystoscopy(year 2)
- cystoscopy(year 3)
- cystoscopy(year 4)
- readjustment of the REMEEX medical device(Month 1)
- readjustment of the REMEEX medical device(Month 6)
- readjustment of the REMEEX medical device(Year 1)
- readjustment of the REMEEX medical device(Year 2)
- readjustment of the REMEEX medical device(Year 3)
- readjustment of the REMEEX medical device(Year 4)
- General improvement of symptoms(1 month)
- General improvement of symptoms(6 months)
- General improvement of symptoms(1 year)
- General improvement of symptoms(2 years)
- General improvement of symptoms(3 years)
- General improvement of symptoms(4 years)
- Improvement of urinary symptoms(1 month)
- Improvement of urinary symptoms(6 months)
- Improvement of urinary symptoms(1 year)
- Improvement of urinary symptoms(2 years)
- Improvement of urinary symptoms(3 years)
- Improvement of urinary symptoms(4 years)
- Side effects or complications(1 month)
- Side effects or complications(6 months)
- Side effects or complications(1 year)
- Side effects or complications(2 years)
- Side effects or complications(3 years)
- Side effects or complications(4 years)
- Reliability and ease of use of the device(1 month)
- Reliability and ease of use of the device(6 months)
- Reliability and ease of use of the device(1 year)
- Reliability and ease of use of the device(2 years)
- Reliability and ease of use of the device(3 years)
- Reliability and ease of use of the device(4 years)
- Patient incontinence-related quality of life(1 month)
- Patient incontinence-related quality of life(6 months)
- Patient incontinence-related quality of life(1 year)
- Patient incontinence-related quality of life(2 years)
- Patient incontinence-related quality of life(3 years)
- Patient incontinence-related quality of life(4 years)
- Patient sexual-related quality of life(1 month)
- Patient sexual-related quality of life(6 months)
- Patient sexual-related quality of life(1 year)
- Patient sexual-related quality of life(2 years)
- Patient sexual-related quality of life(3 years)
- Patient sexual-related quality of life(4 years)
研究者
研究点 (20)
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