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 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. 3. Nutrition - dietary guidance to support surgical recovery and vascular health. 4. Psychological/wellbeing - relaxation techniques, psychoeducation about expected recovery, and self-compassion strategies to address cancer-related anxiety.
A 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.
Adults aged ≥18 years undergoing elective robot-assisted radical prostatectomy (RARP) with curative intent for confirmed prostate cancer.
Consulting a urological surgeon with an appointment at participating sites at least 4 weeks prior to scheduled surgery.
Willingness to engage in prescribed self-directed interventions.
Expected to have 100% unilateral OR >50% bilateral nerve sparing at prostatectomy
Cognitive impairment such that they lack capacity to provide informed consent.
Currently taking intracavernosal injection therapy.
Severe or complete erectile dysfunction at baseline, defined as an IIEF-5 score ≤7 or self-reported absence of erectile function.
Prescribed nitrates or guanylate cyclase stimulators (e.g., riociguat) - pharmacological contraindication to PDE5 inhibitor use.
Parallel
Tadalafil 5 mg
DrugTadalafil 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.
Pelvic Floor Muscle Training (PFMT)
BehavioralSelf-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.
Aerobic Exercise Program
BehavioralSelf-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.
Nutritional Recommendations
BehavioralStructured 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.
Psychological and Wellbeing Strategies
BehavioralSelf-directed psychological wellbeing program comprising: (1) relaxation techniques (progressive muscle relaxation, diaphragmatic/rectangle breathing, mindfulness/grounding); (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.
Standard Perioperative Care
BehavioralUsual 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.
Erectile Function - International Index of Erectile Function-5 (IIEF-5)
The IIEF-5 is a validated 5-item self-report questionnaire assessing erectile function over the preceding 4 weeks. Scores range from 5 (severe erectile dysfunction) to 25 (no erectile dysfunction). A between-group difference of ≥4 points constitutes the minimal clinically important difference (MCID) as established by Rosen et al. (2011). The IIEF-5 is the abbreviated version of the 15-item IIEF, widely used in prostate cancer rehabilitation trials.
Urinary Incontinence - ICIQ-UI SF
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a validated 4-item patient-reported measure of urinary incontinence severity and impact on quality of life. Scores range from 0 (no incontinence) to 21 (severe incontinence). Assesses urinary leakage frequency, volume, and overall impact.
Number of Urinary Pads Used in 24 Hours
Total number of urinary pads used by the participant over a 24-hour period, as self-reported. A higher number of pads indicates greater urinary incontinence severity.
Weight of Urinary Pads Used in 24 Hours
Total weight (grams) of urinary pads used over a 24-hour period. Pad weight is obtained by weighing pads before and after use and calculating the difference. Higher weight indicates greater urine leakage volume.
Maximum Urinary Flow Rate (Uroflowmetry - Q-max)
Maximum urinary flow rate (mL/s) measured by uroflowmetry during voiding. Higher values indicate better bladder outflow function.
Physical Activity Level - International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire (IPAQ) is a validated self-report questionnaire measuring total physical activity across four domains (work, transport, domestic, and leisure) over the preceding 7 days. Total physical activity is expressed as metabolic equivalent of task minutes per week (MET-minutes/week). There is no defined upper limit to the score; higher values indicate greater levels of physical activity, which represents a better outcome.
Intensive Care Unit (ICU) Admission Rate
Proportion of participants admitted to the intensive care unit (ICU) during their postoperative hospital stay following RARP, extracted from medical records.
Intensive Care Unit (ICU) Length of Stay
Total duration of ICU admission (hours) for participants admitted to the ICU postoperatively, extracted from medical records. Assessed only in the subset of participants admitted to the ICU.
30-Day Hospital Readmission Rate
Proportion of participants admitted to hospital within 30 days of RARP surgery, for any cause. Assessed via participant self-report and medical records.
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Surgical Outcomes Research Centre (SOuRCe)
Lead sponsor
Generic Health
Collaborator
National Health and Medical Research Council, Australia
Collaborator
Sydney Local Health District
Collaborator
