RecruitingNot ApplicableNCT07426861

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


Sponsor

Royal College of Surgeons, Ireland

Enrollment

80 participants

Start Date

Dec 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria1

  • 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 Criteria2

  • 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

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.


Locations(1)

Beaumont RCSI Cancer Centre

Beaumont, Dublin, Ireland

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NCT07426861


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