PEHAB II

Trial details

Who runs it

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Trial code

EU 2023-507466-40-00

Record updated

2026. június 18.

Original description

To determine the difference in rates of patients achieving good unassisted erections at 24 months of follow-up after receiving either 12 months of 75/100mg Sildenafil daily and VED therapy 5 times a week or 75/100mg Sildenafil on demand (≤3 times a week) as a penile rehabilitation program.Read full original descriptionShow less

PEnile ReHAbilitation (PEHAB) After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0, a Multicenter, Randomized Clinical Trial

To determine the difference in rates of patients achieving good unassisted erections at 24 months of follow-up after receiving either 12 months of 75/100mg Sildenafil daily and VED therapy 5 times a week or 75/100mg Sildenafil on demand (≤3 times a week) as a penile rehabilitation program.

Inclusion: Pre-screening eligibility criteria: Age > 18 years and < 75 years; Pre-screening eligibility criteria: Motivated to participate in a penile rehabilitation program; Pre-screening eligibility criteria: Patients who have a penis that has developed naturally, without surgical interventions; Pre-screening eligibility criteria: Histologically confirmed PCa; Pre-screening eligibility criteria: Scheduled for RP as primary treatment with the intention of at least a one-sided nerve-sparing procedure; Pre-screening eligibility criteria: Non-metastatic disease (cN0M0); Pre-screening eligibility criteria: Pre-operative erections good enough for intercourse (anamnestic).

Exclusion: Pre-screening exclusion criteria: Regarding history of oncological treatment  Previous pelvic radiation therapy  Patients on Androgen Deprivation Therapy (ADT)  Patients with diseases that affect the red blood cells (e.g., sickle cell anaemia), blood cancer (leukaemia) or bone marrow tumors; Pre-screening exclusion criteria: Other pre-screening exclusion criteria:  Patients with other neurological diseases; such as Parkinson and polyneuropathy.  Allergy regarding Sildenafil  Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.  Patients with severe hepatic impairment  Patients with known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).  Patients using alpha-blockers, but they may be eligible to participate after discontinuing alpha-blocker use.  The inability to speak and read in Dutch; Pre-screening exclusion criteria: Regarding history of cardiovascular diseases  Patients with heart failure New York Heart Association (NYHA) ≥ class 3  Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g., aortic stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure.  Patients with unstable angina pectoris  Patients using nitride oxide for coronary artery disease  Patients with hypotension (blood pressure <90/50 mmHg)  Patients with recent (within the last 6 months) history of stroke (CVA or TIA) or myocardial infarction  Patients with diseases that affect blood clotting or causes bleeding (i.e. coagulation disorders) or prolonged erections  Patients with a severe renal impairment (creatinine clearance <30 mL/min)  Patients with hepatic impairment (cirrhosis).

EU CTIS 2023-507466-40-00