Prostate CancerPRO-ACTNCT07426861
Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence
A study testing Standard Pre-Operative Education and Physiotherapy Recommendation and Pre-Operative Nurse-Led Education with Direct Physiotherapy Referral in people with Prostate Cancer and Urinary Incontinence, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Urinary Incontinence, Postoperative Complications
- What is being tested?
- Standard Pre-Operative Education and Physiotherapy Recommendation and Pre-Operative Nurse-Led Education with Direct Physiotherapy Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIreland
- Study dates
- 20 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged ≥ 18 years Diagnosis of prostate cancer Scheduled for radical prostatectomy (open, laparoscopic, or robotic-assisted) Able to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Beaumont RCSI Cancer Centre
Beaumont, Dublin, D09V2N0
Aisling Hegarty, 0876382425, Aislinghegarty@rcsi.ie
About this study
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Standard Pre-Operative Education and Physiotherapy Recommendation, Pre-Operative Nurse-Led Education with Direct Physiotherapy Referral
- Keywords
- Pelvic Floor Physiotherapy, Preoperative Education, Post-Prostatectomy Incontinence, Continence Recovery
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Pre-Operative Education and Physiotherapy RecommendationOther
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 ReferralBehavioural
Also called PRO ACT CARE BUNDLE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Pre-Operative Nurse-Led Education with Direct Physiotherapy Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-operatively
Secondary outcomes (2)
Mean Number of Urinary Pads Used Per 24 Hours at 6 Weeks
Mean number of urinary pads used per 24-hour period at 6 weeks following surgery, recorded using a 7-day pad diary.
Measured: 6 weeks post-operatively
Time to Continence
Time from surgery to achievement of continence, defined as the first 7 consecutive days with zero pad use.
Measured: Up to 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start20 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426861
- Sponsor's protocol ID
- 25-74
- Acronym
- PRO-ACT
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence
- ClinicalTrials.gov ID
- NCT07426861
- Acronym / sponsor ID
- PRO-ACT / 25-74
- Keywords
- Pelvic Floor Physiotherapy, Preoperative Education, Post-Prostatectomy Incontinence, Continence Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Care Pathway | Active comparator | Other: Standard Pre-Operative Education and Physiotherapy RecommendationParticipants 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. |
| PRO-ACT Intervention Bundle | Experimental | Behavioral: Pre-Operative Nurse-Led Education with Direct Physiotherapy ReferralParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male patients aged ≥ 18 years Diagnosis of prostate cancer Scheduled for radical prostatectomy (open, laparoscopic, or robotic-assisted) Able to provide written informed consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Pre-Operative Education and Physiotherapy RecommendationProvision of educational video material and verbal recommendation for pelvic floor physiotherapy. Referral is patient-initiated, and no scheduled follow-up telephone support is provided. | Other | Standard Care Pathway |
| Pre-Operative Nurse-Led Education with Direct Physiotherapy ReferralAlso: PRO ACT CARE BUNDLEOne-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. | Behavioural | PRO-ACT Intervention Bundle |
Primary outcome
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.
2 secondary outcomes
Mean Number of Urinary Pads Used Per 24 Hours at 6 Weeks
Time frame: 6 weeks post-operatively
Time to Continence
Time frame: Up to 3 months post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Pre-Operative Education and Physiotherapy Recommendation and Pre-Operative Nurse-Led Education with Direct Physiotherapy Referral in people with Prostate Cancer and Urinary Incontinence, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara White (+35318093000, sarawhite@beaumont.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Number of Urinary Pads Used Per 24 Hours (time frame: 3 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.