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โ† Trials
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Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy

RecruitingPhase 2Ages 18 Years - anyMaleSurgical Outcomes Research Centre (SOuRCe)
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In plain words

What the trial is, and whether it could suit you

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. This 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. The program includes four components, all delivered virtually and in a self-directed manner: 1. 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. 2. Exercise - pelvic flo

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Adults aged โ‰ฅ18 years undergoing elective robot-assisted radical prostatectomy (RARP) with curative intent for confirmed prostate cancer. 2. Consulting a urological surgeon with an appointment at participating sites at least 4 weeks prior to scheduled surgery. 3. Willingness to engage in prescribed self-directed interventions. 4. Expected to have 100% unilateral OR \>50% bilateral nerve sparing at prostatectomy Exclusion Criteria: 1. Cognitive impairment such that they lack capacity to provide informed consent. 2. Currently taking intracavernosal injection therapy. 3. Severe or complete erectile dysfunction at baseline, defined as an IIEF-5 score โ‰ค7 or self-reported absence of erectile function. 4. Prescribed nitrates or guanylate cyclase stimulators (e.g., riociguat) - pharmacological contraindication to PDE5 inhibitor use. 5. Impaired renal function (GFR \<50 mL/min and/or creatinine clearance \<30 mL/min). 6. Severe hepatic impairment or concurrent prescription of medications that inhibit CYP3A4. 7. Loss of vision in one eye due to non-arteritic anterior ischaemic optic neuropathy (NAION). 8. Myocardial infarction within the last 90 days. 9. Stroke within the last 6 months. 10. Unstable angina or angina occurring during sexual intercourse. 11. New York Heart Association (NYHA) Class II or greater heart failure in the last 6 months. 12. Uncontrolled arrhythmias, hypotension (\<90/50 mmHg), or uncontrolled hypertension. 13. Contraindications to participating in the prescribed exercise program. 14. No access to a device with internet connectivity.
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What it tests

  • Tadalafil 5 mg
  • Pelvic Floor Muscle Training (PFMT)
  • Aerobic Exercise Program
  • Nutritional Recommendations
  • Psychological and Wellbeing Strategies
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Where

3 sites
Chris O'Brien Lifehouse
Sydney, Australia
Royal Prince Alfred Hospital
Sydney, Australia
Concord Repatriation General Hospital (CRGH)
Sydney, Australia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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