[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625763":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":33,"locations":39,"responsibleParty":59,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Royal College of Surgeons, Ireland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Other: Standard Pre-Operative Education and Physiotherapy Recommendation",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Behavioral: Pre-Operative Nurse-Led Education with Direct Physiotherapy Referral",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","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.",[15],[32],"PRO ACT CARE BUNDLE",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Sara White","CONTACT","+35318093000","sarawhite@beaumont.ie",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Beaumont RCSI Cancer Centre","RECRUITING","Beaumont","Dublin","D09V2N0","Ireland","IE",{"type":49,"coordinates":50},"Point",[51,52],-6.22713,53.38721,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":57,"phoneExt":25,"email":58},"Aisling Hegarty","0876382425","Aislinghegarty@rcsi.ie",{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100625763","pre-operative-nurse-led-education-with-direct-physiotherapy-referral-to-reduce-post-prostatectomy-incontinence-100625763",false,"NCT07426861","Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence","PRO-ACT","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","MALE","18 Years",{"count":71,"type":72},80,"ESTIMATED","INTERVENTIONAL",[75],"NA","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.",[78,79,80,81],"Prostate Cancer","Urinary Incontinence","Postoperative Complications","Radical Prostatectomy",[83,84,85,86],"Pelvic Floor Physiotherapy","Preoperative Education","Post-Prostatectomy Incontinence","Continence Recovery","2026-02-16",{"date":89,"type":90},"2026-02-23","ACTUAL",{"date":92,"type":90},"2025-12-20",{"date":94,"type":72},"2028-12-31",{"name":5,"class":6},1]