A Prospective Randomized Controlled Study Comparing the Efficacy of Pelvic Floor Muscle Training and Oral Duloxetine in the Recovery of Continence After Robotic Assisted Radical Prostatectomy
试验速览
- 阶段
- 3 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Urinary continence proportion
研究概览
简要总结
Objectives:
Primary: Comparison of proportion of patient achieving continence between the four arms at 6 months.
Secondary:
- Comparison of time to achieve continence between the four arms.
- Comparison of urinary symptoms and quality of life improvement between the four arms.
- Assessment of adverse events in Duloxetine arms.
Primary outcome/ time frame: Proportion of patient achieving continence at 6 months. Continence is defined as "using no pad"or "only security pad".
Secondary outcome:
- time to achieve continence
- Quality of life tested in relation to incontinence according to Visual Analog Scale (VAS) and King's Health Questionnaire (KQH).
- Urinary symptoms measured with International Prostate Symptom Score (IPSS).
No. of subjects entered: 300 patients informed and included, 240 patients will be randomized.
Statistical methods
- Proportion of patients who achieve continence and time to achieve continence will be compared between the four arms.
- Comparison of quality of life outcomes between the four arms
- Comparison of clinical variables that can affect the primary/secondary outcome - univariate and multivariate analysis (ITT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients undergoing Robotic Assisted Radical Prostatectomy for clinically organ confined prostate cancer
排除标准
- •Prior urethral, bladder or prostate surgery
- •Pelvic radiotherapy.
- •Overactive bladder
- •Known neurological disease associated to LUTS
- •Hepatic impairment with hepatic insufficiency.
- •Severe renal impairment (creatinine clearance < 30ml/min)
- •Hypersensitivity to duloxetine
- •Uncontrolled hypertension
- •Narrow angle glaucoma
- •Post-operative criteria:
- •Post-void residual urine volume > 100ml measured 15 days after the RARP
研究组 & 干预措施
Pelvic Floor Muscle Training
PMFT weekly for 3 months
干预措施: Pelvic Floor Muscle Training (Behavioral)
Duloxetine
Duloxetine 60mg for 3 months
干预措施: Duloxetine (Drug)
Duloxetine + PMFT
Duloxetine 60mg for 3 months PMFT weekly for 3 months
干预措施: Duloxetine (Drug)
Duloxetine + PMFT
Duloxetine 60mg for 3 months PMFT weekly for 3 months
干预措施: Pelvic Floor Muscle Training (Behavioral)
结局指标
主要结局
Urinary continence proportion
时间窗: 6 months
Proportion of patient achieving continence at 6 months
次要结局
- Urinary quality of life(6 months)
- Urinary continence time(6 months)