Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence

NCT07426861 | Recruiting DMC

• 1 other identifier: 25-74
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Urinary Incontinence; Postoperative Complications; Radical Prostatectomy

Keywords

Pelvic Floor Physiotherapy; Preoperative Education; Post-Prostatectomy Incontinence; Continence Recovery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Mean Number of Urinary Pads Used Per 24 Hours at 6 Weeks

  6 weeks post-operatively

• Time to Continence

  Up to 3 months post-operatively

Study Arms (2)

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.

Other: Standard Pre-Operative Education and Physiotherapy Recommendation

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.

Behavioral: Pre-Operative Nurse-Led Education with Direct Physiotherapy Referral

Interventions

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.

Standard Care Pathway

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.

Also known as: PRO ACT CARE BUNDLE

PRO-ACT Intervention Bundle

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is based on biological sex due to the surgical indication and not restricted by gender identity beyond the clinical requirement.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients aged ≥ 18 years Diagnosis of prostate cancer Scheduled for radical prostatectomy (open, laparoscopic, or robotic-assisted) Able to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (1)

Beaumont RCSI Cancer Centre

Beaumont, Dublin, D09V2N0, Ireland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Incontinence; Postoperative Complications

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Sara White

CONTACT

+35318093000; sarawhite@beaumont.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

IE (1)