NCT07426861

Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Royal College of Surgeons, Ireland · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Prostate Cancer
• Urinary Incontinence
• Postoperative Complications
• Radical Prostatectomy

Interventions

Type	Name	Description
OTHER	Standard Pre-Operative Education and Physiotherapy Recommendation	Provision of educational video material and verbal recommendation for pelvic floor physiotherapy. Referral is patient-initiated, and no scheduled follow-up telephone support is provided.
BEHAVIORAL	Pre-Operative Nurse-Led Education with Direct Physiotherapy Referral	One-to-one pre-operative education session delivered by an Advanced Nurse Practitioner, scheduled follow-up telephone call 7-10 days post-operatively, and direct referral to supervised pelvic floor physiotherapy.

Timeline

• Start date: 2025-12-20
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Ireland