Efficacy of the Pelvic Clock® Device on Functional Recovery After Robotic-Assisted Radical Prostatectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Trifecta Achievement Rate
研究概览
简要总结
This randomized controlled trial evaluates the efficacy of the Pelvic Clock® device, a proprioceptive neuromuscular facilitation tool, in accelerating functional recovery following Robotic-Assisted Radical Prostatectomy (RARP). The study compares the device intervention against standard Pelvic Floor Muscle Training (PFMT) instructions. The primary goal is to assess the "Trifecta" achievement rate (cancer control, urinary continence, and potency) at 6 months post-surgery.
详细描述
Functional recovery, specifically urinary continence and erectile potency, remains a major challenge following RARP. Standard PFMT is often limited by poor patient compliance and incorrect muscle isolation. The Pelvic Clock® device is designed to enhance proprioception and facilitate multi-directional control of pelvic floor muscles. Participants undergoing RARP were randomized 1:1 to either the intervention group (Pelvic Clock + Standard PFMT) or the control group (Standard PFMT alone). Functional outcomes, including incontinence (pad weight), erectile function (IIEF-5), and muscle strength (Oxford scale), were assessed at baseline, 1, 3, and 6 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with localized prostate cancer.
- •Scheduled for Robotic-Assisted Radical Prostatectomy (RARP).
- •Age between 55 and 80 years.
排除标准
- •History of neurological disorders affecting pelvic floor function (e.g., -Parkinson's disease, multiple sclerosis, CVA).
- •Adjuvant radiotherapy or androgen deprivation therapy.
- •Salvage prostatectomy.
- •Advanced tumor stage (cT4 or N+).
- •Prior pelvic surgery or radiation.
- •Cognitive impairment or physical inability to perform prescribed exercises .
研究组 & 干预措施
Experimental: Pelvic Clock Group
Participants performed specific exercises using the Pelvic Clock® device in addition to the standard PFMT regimen.
干预措施: Pelvic Clock® (Device)
Active Comparator: Control Group
Participants received standard of care with verbal and written instructions for Pelvic Floor Muscle Training (PFMT).
干预措施: Standard Pelvic Floor Muscle Training (PFMT) (Behavioral)
结局指标
主要结局
Trifecta Achievement Rate
时间窗: 6 months post-surgery
Composite outcome defined as the simultaneous fulfillment of: (1) Cancer control (PSA \< 0.2 ng/mL); (2) Urinary continence (0 pads/day); and (3) Potency (ability to achieve erection sufficient for intercourse)
次要结局
- Erectile Function (IIEF-5 Score)(Baseline, 1, 3, and 6 months post-surgery)
- Urinary Incontinence (24-hour Pad Weight)(Baseline, 1, 3, and 6 months post-surgery)
- Urinary Quality of Life (EPIC-Urinary Domain)(Baseline, 1, 3, and 6 months post-surgery)
- Pelvic Floor Muscle Strength (Modified Oxford Scale)(Baseline, 1, 3, and 6 months post-surgery)
- Postoperative Pain (VAS)(Baseline, 1, 3, and 6 months post-surgery)
研究者
MING-HSIN, YANG
Dr.
Tri-Service General Hospital