Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy

NCT07576335 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: X26-0106CH62/6/2026-007
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

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. 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. 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. 3.Nutrition - dietary guidance to support surgical recovery and vascular health.
4. 4.Psychological/wellbeing - relaxation techniques, psychoeducation about expected recovery, and self-compassion strategies to address cancer-related anxiety.

Conditions

Erectile Dysfunction Following Radical Prostatectomy; Prostate Cancer; Urinary Incontinence Following Surgical Procedure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed at 3 months postoperatively (primary endpoint). Also assessed at baseline (4 weeks preoperatively), 6 weeks, 6 months, and 12 months postoperatively.

Secondary Outcomes (19)

• Urinary Incontinence - ICIQ-UI SF

  Baseline (≥4 weeks preoperatively), 6 weeks, 3 months, 6 months, and 12 months postoperatively.

• Number of Urinary Pads Used in 24 Hours

  Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.

• Weight of Urinary Pads Used in 24 Hours

  Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.

• Maximum Urinary Flow Rate (Uroflowmetry - Q-max)

  Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.

• Post-Void Residual Urine Volume

  Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.

Other Outcomes (5)

• Physical Activity Level - International Physical Activity Questionnaire (IPAQ)

  Baseline and 3 months postoperatively

• Intensive Care Unit (ICU) Admission Rate

  At hospital discharge (postoperative), assessed up to approximately 5 days.

• Intensive Care Unit (ICU) Length of Stay

  At hospital discharge (postoperative), assessed up to approximately 5 days.

Study Arms (2)

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/day; (3) aerobic exercise 40 min, 4×/week; (4) nutritional guidance; and (5) psychological/wellbeing strategies. All non-pharmacological components are self-directed and digitally delivered.

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

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.

Behavioral: Standard Perioperative Care

Interventions

Tadalafil 5 mg DRUG

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.

Also known as: Tadalafil GH

Multimodal Prehabilitation and Rehabilitation plus standard care

Pelvic Floor Muscle Training (PFMT) BEHAVIORAL

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.

Multimodal Prehabilitation and Rehabilitation plus standard care

Aerobic Exercise Program BEHAVIORAL

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.

Multimodal Prehabilitation and Rehabilitation plus standard care

Nutritional Recommendations BEHAVIORAL

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.

Multimodal Prehabilitation and Rehabilitation plus standard care

Psychological and Wellbeing Strategies BEHAVIORAL

Self-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.

Multimodal Prehabilitation and Rehabilitation plus standard care

Standard Perioperative Care BEHAVIORAL

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.

Multimodal Prehabilitation and Rehabilitation plus standard care; Standard Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Yes - eligibility is based on sex (male); the condition under study (post-prostatectomy erectile dysfunction) is biologically sex-specific.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Impaired renal function (GFR \<50 mL/min and/or creatinine clearance \<30 mL/min).
• Severe hepatic impairment or concurrent prescription of medications that inhibit CYP3A4.
• Loss of vision in one eye due to non-arteritic anterior ischaemic optic neuropathy (NAION).
• Myocardial infarction within the last 90 days.
• Stroke within the last 6 months.
• Unstable angina or angina occurring during sexual intercourse.
• New York Heart Association (NYHA) Class II or greater heart failure in the last 6 months.
• Uncontrolled arrhythmias, hypotension (\<90/50 mmHg), or uncontrolled hypertension.
• Contraindications to participating in the prescribed exercise program.
• No access to a device with internet connectivity.

Sponsors & Collaborators

• Surgical Outcomes Research Centre (SOuRCe): lead
• Generic Health: collaborator
• National Health and Medical Research Council, Australia: collaborator
• Sydney Local Health District: collaborator

Study Sites (3)

Chris O'Brien Lifehouse

Sydney, New South Wales, 2050, Australia

Location

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Concord Repatriation General Hospital (CRGH)

Sydney, New South Wales, 2139, Australia

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction; Urinary Incontinence

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Daniel Steffens

  Surgical Outcomes Research Centre (SOuRCe)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Hirst

CONTACT

+61 2 9515 3200; Nicholas.Hirst1@health.nsw.gov.au

SOuRCe Admin

CONTACT

SLHD-SOuRCe@health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, masking of participants and care providers is not possible. Outcome assessors are blinded to group allocation. Statistical analysis will also be performed blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are assigned 1:1 to one of two parallel arms: (1) multimodal prehabilitation and rehabilitation program (plus standard care), or (2) standard care alone. Randomisation is stratified by age (≤60 vs \>60 years) using permuted blocks of size 2 and 4 via a central REDCap module.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)