Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07426861

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

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: PRO ACT CARE BUNDLE

Primary outcomes

  1. Mean Number of Urinary Pads Used Per 24 Hours

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Time to Continence

    Time frame: Up to 3 months post-operatively

    Time from surgery to achievement of continence, defined as the first 7 consecutive days with zero pad use.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara White

CONTACT

[email protected]

+35318093000

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Registry information

Acronym: PRO-ACT

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.