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Clinical Trials in Ireland / NCT07426861
Recruiting Not applicable

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

NCT07426861 · tracked via the Priya Life Science Ireland tracker
Sponsor
Royal College of Surgeons, Ireland
Phase
Not applicable
Started
2025-12-20
Last updated
2026-02-23

Condition(s) studied

Prostate CancerUrinary IncontinencePostoperative ComplicationsRadical Prostatectomy

Investigational drug(s) / intervention(s)

Standard Pre-Operative Education and Physiotherapy RecommendationPre-Operative Nurse-Led Education with Direct Physiotherapy Referral

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.

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.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Mean Number of Urinary Pads Used Per 24 Hours — 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.

Trial sites (1)

FacilityCityRegionStatus
Beaumont RCSI Cancer Centre Beaumont Dublin Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07426861 on ClinicalTrials.gov ↗ ← All trials in Ireland