[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638434":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":54,"centralContacts":58,"locations":67,"responsibleParty":100,"collaborators":102,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":37,"enrollmentInfo":122,"targetDuration":37,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":133,"overallStatus":146,"whyStopped":37,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Surgical Outcomes Research Centre (SOuRCe)","NETWORK",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Multimodal Prehabilitation and Rehabilitation plus standard care","EXPERIMENTAL","Participants receive standard care PLUS a multimodal program commencing ≥4 weeks preoperatively and continuing for 3 months postoperatively (following catheter removal). The program comprises four components: (1) tadalafil 5 mg orally once daily (paused during hospital admission); (2) pelvic floor muscle training 3 sets\u002Fday; (3) aerobic exercise 40 min, 4×\u002Fweek; (4) nutritional guidance; and (5) psychological\u002Fwellbeing strategies. All non-pharmacological components are self-directed and digitally delivered.",[13,14,15,16,17,18],"Drug: Tadalafil 5 mg","Behavioral: Pelvic Floor Muscle Training (PFMT)","Behavioral: Aerobic Exercise Program","Behavioral: Nutritional Recommendations","Behavioral: Psychological and Wellbeing Strategies","Behavioral: Standard Perioperative Care",{"label":20,"type":21,"description":22,"interventionNames":23},"Standard Care","ACTIVE_COMPARATOR","Participants receive usual high-standard perioperative care from their treating team, including clinical advice on exercise, nutrition, smoking cessation, alcohol reduction, expected surgical sequelae, and pelvic floor exercises, as well as medical considerations (blood sugar optimisation, medication review, anaemia screening). Prostate cancer nurse specialist consultations and urology clinic attendance are included as standard.",[18],[25,32,38,42,46,50],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Tadalafil 5 mg","Tadalafil 5 mg tablet, taken orally once daily. Commenced 4 weeks prior to surgery, ceased during hospital admission (3 days prior to surgery), and recommenced following postoperative urinary catheter removal (typically 5-10 days post-surgery) for 3 months. Total intended duration approximately 4 months. Supplied via standard prescription dispensing at community pharmacies (Generic Health brand). Reimbursement provided to participants via a cash card. TGA ARTG number: 289541.",[9],[31],"Tadalafil GH",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BEHAVIORAL","Pelvic Floor Muscle Training (PFMT)","Self-directed PFMT performed 3 sets per day. Each set comprises 20 fast contractions (1-second duration) and 20 slow contractions (10 seconds on, 10 seconds off). Adapted from Milios et al. (2020) using Continence Australia guidelines. Delivered via co-designed digital booklet and avatar instructional videos. Commenced 4 weeks preoperatively, continuing through 3 months postoperatively.",[9],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Aerobic Exercise Program","Self-directed aerobic exercise at moderate-to-vigorous intensity (e.g., brisk walking while able to maintain conversation), 40 minutes per session, 4 sessions per week. Dose established by Gerbild et al. (2018). Delivered via digital booklet and avatar videos. Commenced 4 weeks preoperatively, continuing through 3 months postoperatively.",[9],{"type":33,"name":43,"description":44,"armGroupLabels":45,"otherNames":37},"Nutritional Recommendations","Structured dietary guidance addressing protein intake, fruit and vegetable consumption, wholegrains, healthy fats, hydration, and blood sugar control. Designed by a dietitian to support surgical healing, vascular health, and erectile and urinary function recovery. Delivered via digital booklet and avatar videos. Commenced 4 weeks preoperatively, continuing through 3 months postoperatively.",[9],{"type":33,"name":47,"description":48,"armGroupLabels":49,"otherNames":37},"Psychological and Wellbeing Strategies","Self-directed psychological wellbeing program comprising: (1) relaxation techniques (progressive muscle relaxation, diaphragmatic\u002Frectangle breathing, mindfulness\u002Fgrounding); (2) psychoeducation on psychogenic erectile dysfunction, expected postoperative complications (ED, UI); (3) self-compassion and cognitive reframing strategies; (4) motivational interviewing-style elements to support adherence; (5) advice on social connection, smoking cessation, alcohol reduction, and sleep hygiene. Designed by a clinical psychologist and delivered via digital booklet and videos. Commenced 4 weeks preoperatively, continuing through 3 months postoperatively.",[9],{"type":33,"name":51,"description":52,"armGroupLabels":53,"otherNames":37},"Standard Perioperative Care","Usual high-standard pre- and postoperative care delivered by the treating urological team, including clinical advice on exercise, nutrition, smoking cessation, alcohol reduction, expected surgical sequelae, pelvic floor exercises, blood sugar optimisation, medication review, and anaemia screening. Includes prostate cancer nurse specialist consultations and urology clinic follow-up.",[9,20],[55],{"name":56,"affiliation":5,"role":57},"Daniel Steffens","PRINCIPAL_INVESTIGATOR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":37,"email":63},"Nicholas Hirst","CONTACT","+61 2 9515 3200","Nicholas.Hirst1@health.nsw.gov.au",{"name":65,"role":61,"phone":37,"phoneExt":37,"email":66},"SOuRCe Admin","SLHD-SOuRCe@health.nsw.gov.au",[68,85,92],{"facility":69,"status":37,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Chris O'Brien Lifehouse","Sydney","New South Wales","2050","Australia","AU",{"type":76,"coordinates":77},"Point",[78,79],151.20732,-33.86785,{"lat":79,"lon":78},[82],{"name":60,"role":61,"phone":83,"phoneExt":37,"email":84},"+61 2 9515 3211","nicholas.hirst1@health.nsw.gov.au",{"facility":86,"status":37,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"Royal Prince Alfred Hospital",{"type":76,"coordinates":88},[78,79],{"lat":79,"lon":78},[91],{"name":60,"role":61,"phone":83,"phoneExt":37,"email":84},{"facility":93,"status":37,"city":70,"state":71,"zip":94,"country":73,"countryCode":74,"cosmosGeoPoint":95,"geoPoint":97,"contacts":98},"Concord Repatriation General Hospital (CRGH)","2139",{"type":76,"coordinates":96},[78,79],{"lat":79,"lon":78},[99],{"name":60,"role":61,"phone":83,"phoneExt":37,"email":84},{"type":57,"investigatorFullName":56,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Professor",[103,106,109],{"name":104,"class":105},"Generic Health","UNKNOWN",{"name":107,"class":108},"National Health and Medical Research Council, Australia","OTHER",{"name":110,"class":111},"Sydney Local Health District","OTHER_GOV","100638434","phase-2-multimodal-prehabilitation-and-rehabilitation-for-men-undergoing-robot-assisted-radical-prostatectomy-100638434",false,"NCT07576335","Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy","Multimodal Perioperative Optimisation for Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomised Controlled Trial Targeting Postoperative Erectile Dysfunction (ROBOPREP Trial)","ROBOPREP","Inclusion Criteria:\n\n1. Adults aged ≥18 years undergoing elective robot-assisted radical prostatectomy (RARP) with curative intent for confirmed prostate cancer.\n2. Consulting a urological surgeon with an appointment at participating sites at least 4 weeks prior to scheduled surgery.\n3. Willingness to engage in prescribed self-directed interventions.\n\nExclusion Criteria:\n\n1. Cognitive impairment such that they lack capacity to provide informed consent.\n2. Currently taking intracavernosal injection therapy.\n3. Severe or complete erectile dysfunction at baseline, defined as an IIEF-5 score ≤7 or self-reported absence of erectile function.\n4. Prescribed nitrates or guanylate cyclase stimulators (e.g., riociguat) - pharmacological contraindication to PDE5 inhibitor use.\n5. Impaired renal function (GFR \\\u003C50 mL\u002Fmin and\u002For creatinine clearance \\\u003C30 mL\u002Fmin).\n6. Severe hepatic impairment or concurrent prescription of medications that inhibit CYP3A4.\n7. Loss of vision in one eye due to non-arteritic anterior ischaemic optic neuropathy (NAION).\n8. Myocardial infarction within the last 90 days.\n9. Stroke within the last 6 months.\n10. Unstable angina or angina occurring during sexual intercourse.\n11. New York Heart Association (NYHA) Class II or greater heart failure in the last 6 months.\n12. Uncontrolled arrhythmias, hypotension (\\\u003C90\u002F50 mmHg), or uncontrolled hypertension.\n13. Contraindications to participating in the prescribed exercise program.\n14. No access to a device with internet connectivity.","MALE","18 Years",{"count":123,"type":124},64,"ESTIMATED","INTERVENTIONAL",[127],"PHASE2","Prostate cancer is the most common cancer in Australian men. Robot-assisted radical prostatectomy (RARP) - surgical removal of the prostate - is a standard treatment, but it frequently causes erectile dysfunction (ED) and urinary incontinence that can persist for years and significantly affect quality of life.\n\nThis trial (ROBOPREP) will test whether a multimodal program of prehabilitation (before surgery) and rehabilitation (after surgery) improves erectile function and urinary continence in men undergoing RARP, compared to standard care alone.\n\nThe program includes four components, all delivered virtually and in a self-directed manner:\n\n1. Pharmacological - tadalafil 5 mg once daily (a low-dose, TGA-approved erectile medication) beginning 4 weeks before surgery, paused during hospital admission, and resumed for 3 months following catheter removal after surgery.\n2. Exercise - pelvic floor muscle training (3 sets per day) and aerobic exercise (40 minutes, 4 times per week) to strengthen the muscles and vascular supply involved in erectile and urinary function.\n3. Nutrition - dietary guidance to support surgical recovery and vascular health.\n4. Psychological\u002Fwellbeing - relaxation techniques, psychoeducation about expected recovery, and self-compassion strategies to address cancer-related anxiety.\n\nA total of 64 men will be recruited across three major Sydney hospitals (Royal Prince Alfred Hospital, Concord Repatriation General Hospital, and Chris O'Brien Lifehouse) and randomly assigned 1:1 to the multimodal program plus standard care, or to standard care alone. Outcomes - including erectile function (primary), urinary continence, quality of life, and psychological wellbeing - are assessed at baseline and at 6 weeks, 3, 6, and 12 months following surgery. All participant-facing elements of the program are digital, low-cost, and designed for real-world scalability.",[130,131,132],"Erectile Dysfunction Following Radical Prostatectomy","Prostate Cancer","Urinary Incontinence Following Surgical Procedure",[134,135,136,137,138,139,140,141,142,143,144,145],"robot-assisted radical prostatectomy","prehabilitation","rehabilitation","erectile dysfunction","urinary incontinence","PDE5 inhibitor","tadalafil","pelvic floor muscle training","prostate cancer","sexual rehabilitation","perioperative care","multimodal intervention","NOT_YET_RECRUITING","2026-05-04",{"date":149,"type":150},"2026-05-08","ACTUAL",{"date":152,"type":124},"2026-05-01",{"date":154,"type":124},"2028-11-01",{"name":5,"class":6},3]