Nurse-led pre-op education with direct physiotherapy referral to reduce leakage after prostate removal
Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence
This project sees if a one-to-one nurse-led pre-operative education session plus automatic referral to supervised pelvic floor physiotherapy reduces urinary leakage in men having radical prostatectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Royal College of Surgeons, Ireland Academic / other |
| Locations | 1 site (Beaumont, Dublin) |
| Trial ID | NCT07426861 on ClinicalTrials.gov |
What this trial studies
The PRO-ACT trial is a single-centre, parallel-group randomized controlled trial at Beaumont RCSI Cancer Centre that randomises men 1:1 to either standard care or a structured pre-operative bundle. The intervention includes a one-to-one advanced nurse practitioner education session, a scheduled 7–10 day post-operative telephone follow-up, and direct referral to supervised pelvic floor physiotherapy, while the control arm receives an educational video and patient-initiated referral. The primary outcome is mean urinary pad use per 24 hours at three months measured using a seven-day pad diary, with secondary outcomes including time to continence, EQ-5D-5L quality-of-life scores, physiotherapy uptake, and 90-day complications. Follow-up visits occur at six weeks and three months post-operatively.
Who should consider this trial
Good fit: Men aged 18 or older with prostate cancer who are scheduled for radical prostatectomy, can give informed consent, and have no pre-existing incontinence or contraindication to pelvic floor physiotherapy.
Not a fit: Patients with pre-existing urinary incontinence, prior pelvic radiotherapy or prior prostate surgery that affects continence, or medical contraindications to physiotherapy are unlikely to benefit from this pathway.
Why it matters
Potential benefit: If successful, the intervention could shorten the time men take to regain continence after prostatectomy and improve post-operative quality of life.
How similar studies have performed: Pelvic floor muscle training has been shown in prior trials to improve post-prostatectomy continence, but structured pre-operative nurse-led education with automatic physiotherapy referral has been less extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beaumont, Dublin
- Beaumont RCSI Cancer Centre — Beaumont, Dublin, Ireland (Recruiting)
Study contacts
- Study coordinator: Sara White
- Email: sarawhite@beaumont.ie
- Phone: +35318093000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.