Postoperative Complications, Prostate Cancer, Radical Prostatectomy, Urinary Incontinence
Conditions
Keywords
Pelvic Floor Physiotherapy, Preoperative Education, Post-Prostatectomy Incontinence, Continence Recovery
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.
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
OTHERStandard 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.
BEHAVIORALPre-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.
Sponsors
Royal College of Surgeons, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Blinding is not feasible due to the behavioural and referral-based nature of the intervention. Participants, clinicians, and investigators will be aware of allocation. Outcome measures are primarily patient-reported (pad diary and questionnaires).
Intervention model description
This is a prospective, single-centre, parallel-group randomised controlled trial. Eligible men undergoing radical prostatectomy will be randomised in a 1:1 ratio to either standard care or a structured pre-operative nurse-led education bundle with direct referral to supervised pelvic floor physiotherapy. Randomisation will be computer-generated with allocation concealed until assignment. Follow-up assessments will occur at 6 weeks and 3 months post-operatively. Analysis will be conducted on an intention-to-treat basis.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Continence | Up to 3 months post-operatively | Time from surgery to achievement of continence, defined as the first 7 consecutive days with zero pad use. |
| Mean Number of Urinary Pads Used Per 24 Hours at 6 Weeks | 6 weeks post-operatively | Mean number of urinary pads used per 24-hour period at 6 weeks following surgery, recorded using a 7-day pad diary. |
Countries
Ireland
Contacts
CONTACTSara White
Outcome results
None listed