Prospective Randomized Controlled Trial to Compare Early Urinary Continence Recovery After Robotic Assisted Radical Prostatectomy With or Without Posterior Rhabdosphincter Reconstruction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month
研究概览
简要总结
This is a prospective randomized controlled trail to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not. A hundred forty-six patients with clinically localized and histological confirmed prostate cancer will be enrolled. Continence recovery is defined in the present study as declared urinary continence (absence of incontinence episodes) in the physician interview as no pad use. Continence rates will be explored also by EPIC, ICIQ-SF, IPSS questionnaires 1, 6 and 12 months after the procedure. The sexual function as the secondary objective will be assessed by SHIM questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of prostate cancer
- •Localized or locally advanced prostate cancer
- •Informed consent signed
排除标准
- •Presence of urinary incontinence prior to the procedure
- •Previous radiation therapy of the prostate or pelvis
- •Presence of any prostatic surgery prior to the procedure
- •Prior medical history of psychiatric diseases or drug addiction
- •Any condition that contraindicates a radical prostatectomy
结局指标
主要结局
Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month
时间窗: 6 months after surgery
Absence of urinary incontinence (number of PADs/d)
Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st monthNumber of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st month
时间窗: 1 month after surgery
Absence of urinary incontinence (number of PADs/d)
次要结局
- Quality of life III: urinary function(1, 6 and 12 months)
- Quality of life II: urinary function(1, 6 and 12 months)
- Oncological outcome: Biochemical free-recurrence status(1, 6 and 12 months)
- early urinary recovery quantification in Grams (PAD-test 24h)(one day before catheter removal, 2 weeks before and 1 month before)
- Erectile function(1, 6 and 12 months)
- Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 12th month(12 months after surgery)
- Quality of life I: urinary and bowel function(1, 6 and 12 months)
- Anatomopathological parameters: pTNM classification(1 month)
- Anatomopathological parameters: Surgical margins(1 month)