Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean Number of Urinary Pads Used Per 24 Hours
研究概览
简要总结
Urinary incontinence is a common complication following radical prostatectomy and can significantly impact quality of life. Pelvic floor physiotherapy is recommended to reduce post-operative incontinence; however, referral pathways and patient engagement vary.
The PRO-ACT trial is a single-centre, parallel-group randomised controlled trial evaluating whether a structured pre-operative education bundle combined with direct physiotherapy referral reduces urinary incontinence following radical prostatectomy compared to standard care.
Eligible men undergoing radical prostatectomy at Beaumont Hospital will be randomised 1:1 to either:
Standard of care (educational video and recommendation for physiotherapy with patient-initiated referral), or
A structured pre-operative intervention including a one-to-one ANP-led education session, scheduled post-operative follow-up call, and direct referral to supervised pelvic floor physiotherapy.
The primary outcome is mean urinary pad usage per 24 hours at 3 months post-operatively. Secondary outcomes include time to continence, quality of life, physiotherapy adherence, and postoperative complication rates.
详细描述
Radical prostatectomy is a definitive treatment for localised prostate cancer but is frequently associated with post-operative urinary incontinence. Pelvic floor muscle training has been shown to improve continence outcomes; however, inconsistent referral practices and limited early engagement may reduce effectiveness.
The PRO-ACT study evaluates whether a structured pre-operative pathway improves continence outcomes compared to standard care.
This is a prospective, single-centre, parallel-group randomised controlled trial conducted at Beaumont Hospital.
Participants will be randomised 1:1 to:
Control Group (Standard Care):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Blinding is not feasible due to the behavioural and referral-based nature of the intervention. Participants, clinicians, and investigators will be aware of allocation. Outcome measures are primarily patient-reported (pad diary and questionnaires).
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
- •Male patients aged ≥ 18 years Diagnosis of prostate cancer Scheduled for radical prostatectomy (open, laparoscopic, or robotic-assisted) Able to provide written informed consent
排除标准
- •Pre-existing urinary incontinence requiring pad use Prior pelvic radiotherapy Prior prostate surgery affecting continence outcomes Medical contraindication to participation in pelvic floor physiotherapy
- •Inability to provide informed consent
研究组 & 干预措施
Standard Care Pathway
Participants randomised to this group will receive standard pre-operative counselling and educational video material regarding pelvic floor exercises. Physiotherapy referral will be recommended by the Advanced Nurse Practitioner (ANP), but referral will be patient-initiated. No scheduled post-operative follow-up telephone call will be arranged.
干预措施: Standard Pre-Operative Education and Physiotherapy Recommendation (Other)
PRO-ACT Intervention Bundle
Participants randomised to this group will receive a structured pre-operative education session delivered by an ANP, a scheduled post-operative follow-up telephone call at 7-10 days, and direct referral to supervised pelvic floor physiotherapy. The intervention aims to improve engagement with pelvic floor muscle training following radical prostatectomy.
干预措施: Pre-Operative Nurse-Led Education with Direct Physiotherapy Referral (Behavioral)
结局指标
主要结局
Mean Number of Urinary Pads Used Per 24 Hours
时间窗: 3 months post-operatively
Mean number of urinary pads used per 24-hour period at 3 months following radical prostatectomy, recorded using a 7-day pad diary completed by participants.
次要结局
- Mean Number of Urinary Pads Used Per 24 Hours at 6 Weeks(6 weeks post-operatively)
- Time to Continence(Up to 3 months post-operatively)