Heather K Moriarty1,2,3, Helen Kavnoudias4,5,6,7, Gideon Blecher6,7, Adil Zia4,6,7, Warren Clements4,5,7, Gerard S Goh4,5,7, Samantha J Ellis4,5,7,8, Tuan Phan4,7. 1. Department of Radiology, Alfred hospital, Melbourne, Australia. heather.moriarty@gmail.com. 2. Department of Surgery, Monash University, Clayton, Australia. heather.moriarty@gmail.com. 3. Department of Urology, Alfred hospital, Melbourne, Australia. heather.moriarty@gmail.com. 4. Department of Radiology, Alfred hospital, Melbourne, Australia. 5. Department of Surgery, Monash University, Clayton, Australia. 6. Department of Neuroscience, Monash University, Melbourne, Australia. 7. Department of Urology, Alfred hospital, Melbourne, Australia. 8. Australian and New Zealand Society of Thoracic Radiology, Monash University, Melbourne, Australia.
Abstract
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.
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.
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