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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Поведенческое 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.

Первичные конечные точки

• Mean Number of Urinary Pads Used Per 24 Hours [Срок оценки: 3 months post-operatively]

Вторичные конечные точки (2)

• Mean Number of Urinary Pads Used Per 24 Hours at 6 Weeks [Срок оценки: 6 weeks post-operatively]
• Time to Continence [Срок оценки: Up to 3 months post-operatively]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Ирландия · 1 центр

• Beaumont RCSI Cancer Centre — Beaumont

Идентификаторы

NCT: NCT07426861 · 25-74

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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