Overview
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.
Description
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):
ANP recommendation for pelvic floor physiotherapy
Provision of educational video
Patient-initiated physiotherapy referral
No scheduled post-operative follow-up call
Intervention Group (PRO-ACT Bundle):
One-to-one pre-operative education session delivered by an Advanced Nurse Practitioner
Scheduled follow-up telephone call 7-10 days post-operatively
Direct referral to supervised pelvic floor physiotherapy
Follow-up will occur at 6 weeks and 3 months post-operatively.
The primary endpoint is mean pad usage per 24 hours at 3 months, measured using a 7-day pad diary. Secondary endpoints include time to continence (defined as 7 consecutive days with zero pad use), EQ-5D-5L quality-of-life measures, physiotherapy uptake, and 90-day postoperative complications.
Eligibility
Inclusion Criteria:
Male patients aged ≥ 18 years Diagnosis of prostate cancer Scheduled for radical prostatectomy (open, laparoscopic, or robotic-assisted) Able to provide written informed consent
Exclusion Criteria:
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