Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Pre-Operative Education and Physiotherapy Recommendation, Pre-Operative Nurse-Led Education with Direct Physiotherapy Referral.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Urinary Incontinence, Postoperative Complications, Radical Prostatectomy. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
Interventions
- 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.
Primary outcome measures
- Mean Number of Urinary Pads Used Per 24 Hours [Time frame: 3 months post-operatively]
Secondary outcome measures (2)
- Mean Number of Urinary Pads Used Per 24 Hours at 6 Weeks [Time frame: 6 weeks post-operatively]
- Time to Continence [Time frame: Up to 3 months post-operatively]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Ireland · 1 center
- Beaumont RCSI Cancer Centre — Beaumont
Identifiers
NCT: NCT07426861 · 25-74