Beaumont RCSI Cancer Centre
Beaumont, Dublin, D09V2N0, Ireland
Location status: Recruiting
NCT Number: NCT07426861
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.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Beaumont, Dublin, D09V2N0, Ireland
Location status: Recruiting
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.
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
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.
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
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Royal College of Surgeons, Ireland
Other
Acronym: PRO-ACT
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.
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