PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0, a Multicentre, Randomized Clinical Trial (PEHAB-II)
The PEHAB-II study is prospective, randomized trial designed to assess the effect of two different rehabilitation strategies on the recovery of erectile function in nerve sparing prostatectomy patients. The two rehabilitation strategies consist of 1)12 months daily doses of 100 mg Sildenafil combined with vacuum device (VED) therapy for 10 minutes a day, five times a week or 2) Standard of care: monotherapy with an on-demand dosage of 100mg Sildenafil. The study will be performed in multiple centers in the Netherlands.
⁃ Pre-screening eligibility criteria
• Age \> 18 years and \< 70 years
• Patients who have a penis that has developed naturally, without surgical interventions.
• Histologically confirmed PCa
• Scheduled for RP as primary treatment with the intention of at least a one-sided nerve-sparing procedure.
• Non-metastatic disease (cN0M0)
• Pre-operative erections good enough for intercourse (anamnestic)
• Motivated to participate in a penile rehabilitation program
⁃ To be eligible to participate in this study, a subject must meet all of the following post- operative criteria:
• All of the above-mentioned pre-screening eligibility criteria
• At least unilateral nerve-sparing or if available Fascia Preservation (FP) score =\>5
• A pre-diagnostic anamnestic erection that was good enough for intercourse.
• A pre-diagnostic IIEF-EF\>=22 with or without PDE5i. For patients without a partner or did not participate in penetrative sex we use accumulated score of EPIC- erectile function; Q8b, Q9 and Q10 \>=83.
• Willing to provide one blood sample to determine testosterone level, hemoglobin 1Ac, liver enzymes and lipid profile
• Testosterone levels of at least \>=12 nmol/l, measured pre or post-operative
• A signed informed consent form