NCT07426861 Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence
| NCT ID | NCT07426861 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal College of Surgeons, Ireland |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-12-20 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-12-20 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07426861 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07426861 currently recruiting?
Yes, NCT07426861 is actively recruiting participants. Contact the research team at sarawhite@beaumont.ie for enrollment information.
Where is the NCT07426861 trial being conducted?
This trial is being conducted at Beaumont, Ireland.
Who is sponsoring the NCT07426861 clinical trial?
NCT07426861 is sponsored by Royal College of Surgeons, Ireland. The trial plans to enroll 80 participants.
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