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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care Pathway | Active Comparator | Participants randomised to this group will receive standard pre-operative counselling and educational video material regarding pelvic floor exercises. Physiotherapy referral will be recommended by the Advanced Nurse Practitioner (ANP), but referral will be patient-initiated. No scheduled post-operative follow-up telephone call will be arranged. |
|
| PRO-ACT Intervention Bundle | Experimental | Participants randomised to this group will receive a structured pre-operative education session delivered by an ANP, a scheduled post-operative follow-up telephone call at 7-10 days, and direct referral to supervised pelvic floor physiotherapy. The intervention aims to improve engagement with pelvic floor muscle training following radical prostatectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Pre-Operative Education and Physiotherapy Recommendation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Urinary Pads Used Per 24 Hours | 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. | 3 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Urinary Pads Used Per 24 Hours at 6 Weeks | Mean number of urinary pads used per 24-hour period at 6 weeks following surgery, recorded using a 7-day pad diary. | 6 weeks post-operatively |
| Time to Continence |
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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
Eligibility is based on biological sex due to the surgical indication and not restricted by gender identity beyond the clinical requirement.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara White | Contact | +35318093000 | sarawhite@beaumont.ie |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont RCSI Cancer Centre | Recruiting | Beaumont | Dublin | D09V2N0 | Ireland |
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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.
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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).
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| Pre-Operative Nurse-Led Education with Direct Physiotherapy Referral | Behavioral | 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. |
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Time from surgery to achievement of continence, defined as the first 7 consecutive days with zero pad use.
| Up to 3 months post-operatively |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D014549 | Urinary Incontinence |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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