PIVET-ED: A Prospective, Randomised, Single-Blinded, Sham Controlled Study of Pelvic Vein Embolisation for Treatment of Erectile Dysfunction

Purpose: Erectile Dysfunction (ED) is defined as the inability to obtain or maintain an erection firm enough for satisfactory sexual performance and affects the quality of life of over 50% of men aged over 40 years. Venogenic ED is elucidated as a cause in a subgroup of patients. The study aims to investigate the clinical success, technical success, safety and durability of venous embolisation for management of venogenic ED. Methods: After providing informed consent, and subsequent to confirmation of venogenic ED by Doppler ultrasound (dUS) and cavernosography, 80 men referred for cavernosography and pelvic vein embolisation, will undergo randomisation by a computer system either to treatment or sham groups. Efficacy will be assessed using dUS and a validated questionnaire, the International Index of Erectile Function (IIEF). Pharmacologic agents used during the trial will be recorded. The primary outcome of PiVET-ED is to establish clinical success at 3 and 6 months post venous embolisation, as defined by end diastolic velocity in the cavernosal artery < 5 cm/s with dUS and by a > 4-point improvement in IIEF. Durability of the embolisation procedure will be assessed annually to 5 years. Quality of life will be assessed at all study time points using the 36-Item Short Form Survey (SF-36). Discussion: The PiVET-ED trial is a prospective, randomised, single-blinded, single centre, sham controlled study, which aims to establish the safety, efficacy and durability of pelvic vein embolisation for the treatment of venogenic erectile dysfunction. Clinical registration: Australian New Zealand Clinical Trials Registry ACTRN12620001023943, 08/10/2020.