PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-70
SponsorThe Netherlands Cancer Institute
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 Regarding history of cardiovascular diseases
Patients with heart failure New York Heart Association (NYHA) ≥ class 3
Trial design
Treatments tested in this trial
- Sildenafil
- Erectile vacuum device
Treatment groups
198 Participants
are divided into 2 treatment groupsSponsors and collaborators
The Netherlands Cancer Institute
Lead sponsor
Antoni van Leeuwenhoek Hospital
Collaborator
Viatris Inc.
Collaborator
Memidis Pharma
Collaborator
Source ClinicalTrials.gov