Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:23 AM
Study NCT ID:
NCT07426861
Status:
RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Blinding is not feasible due to the behavioural and referral-based nature of the intervention. Participants, clinicians, and investigators will be aware of allocation. Outcome measures are primarily patient-reported (pad diary and questionnaires).'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Number of Urinary Pads Used Per 24 Hours', 'timeFrame': '3 months post-operatively', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mean Number of Urinary Pads Used Per 24 Hours at 6 Weeks', 'timeFrame': '6 weeks post-operatively', 'description': 'Mean number of urinary pads used per 24-hour period at 6 weeks following surgery, recorded using a 7-day pad diary.'}, {'measure': 'Time to Continence', 'timeFrame': 'Up to 3 months post-operatively', 'description': 'Time from surgery to achievement of continence, defined as the first 7 consecutive days with zero pad use.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pelvic Floor Physiotherapy', 'Preoperative Education', 'Post-Prostatectomy Incontinence', 'Continence Recovery'], 'conditions': ['Prostate Cancer', 'Urinary Incontinence', 'Postoperative Complications', 'Radical Prostatectomy']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nEligible men undergoing radical prostatectomy at Beaumont Hospital will be randomised 1:1 to either:\n\nStandard of care (educational video and recommendation for physiotherapy with patient-initiated referral), or\n\nA 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.\n\nThe 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.', 'detailedDescription': '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.\n\nThe PRO-ACT study evaluates whether a structured pre-operative pathway improves continence outcomes compared to standard care.\n\nThis is a prospective, single-centre, parallel-group randomised controlled trial conducted at Beaumont Hospital.\n\nParticipants will be randomised 1:1 to:\n\nControl Group (Standard Care):\n\nANP recommendation for pelvic floor physiotherapy\n\nProvision of educational video\n\nPatient-initiated physiotherapy referral\n\nNo scheduled post-operative follow-up call\n\nIntervention Group (PRO-ACT Bundle):\n\nOne-to-one pre-operative education session delivered by an Advanced Nurse Practitioner\n\nScheduled follow-up telephone call 7-10 days post-operatively\n\nDirect referral to supervised pelvic floor physiotherapy\n\nFollow-up will occur at 6 weeks and 3 months post-operatively.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Eligibility is based on biological sex due to the surgical indication and not restricted by gender identity beyond the clinical requirement.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale patients aged ≥ 18 years Diagnosis of prostate cancer Scheduled for radical prostatectomy (open, laparoscopic, or robotic-assisted) Able to provide written informed consent\n\nExclusion Criteria:\n\nPre-existing urinary incontinence requiring pad use Prior pelvic radiotherapy Prior prostate surgery affecting continence outcomes Medical contraindication to participation in pelvic floor physiotherapy\n\nInability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07426861', 'acronym': 'PRO-ACT', 'briefTitle': 'Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Royal College of Surgeons, Ireland'}, 'officialTitle': 'Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence', 'orgStudyIdInfo': {'id': '25-74'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care Pathway', 'description': '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.', 'interventionNames': ['Other: Standard Pre-Operative Education and Physiotherapy Recommendation']}, {'type': 'EXPERIMENTAL', 'label': 'PRO-ACT Intervention Bundle', 'description': '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.', 'interventionNames': ['Behavioral: Pre-Operative Nurse-Led Education with Direct Physiotherapy Referral']}], 'interventions': [{'name': 'Standard Pre-Operative Education and Physiotherapy Recommendation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Standard Care Pathway']}, {'name': 'Pre-Operative Nurse-Led Education with Direct Physiotherapy Referral', 'type': 'BEHAVIORAL', 'otherNames': ['PRO ACT CARE BUNDLE'], 'description': '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.', 'armGroupLabels': ['PRO-ACT Intervention Bundle']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D09V2N0', 'city': 'Beaumont', 'state': 'Dublin', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Aisling Hegarty', 'role': 'CONTACT', 'email': 'Aislinghegarty@rcsi.ie', 'phone': '0876382425'}], 'facility': 'Beaumont RCSI Cancer Centre', 'geoPoint': {'lat': 53.38721, 'lon': -6.22713}}], 'centralContacts': [{'name': 'Sara White', 'role': 'CONTACT', 'email': 'sarawhite@beaumont.ie', 'phone': '+35318093000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal College of Surgeons, Ireland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}