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

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  • Venous Interventions
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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.

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Funding

This study was not supported by any funding.

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Authors and Affiliations

  1. Department of Radiology, Alfred hospital, Melbourne, Australia

    Heather K. Moriarty, Helen Kavnoudias, Adil Zia, Warren Clements, Gerard S. Goh, Samantha J. Ellis & Tuan Phan

  2. Department of Surgery, Monash University, Clayton, Australia

    Heather K. Moriarty, Helen Kavnoudias, Warren Clements, Gerard S. Goh & Samantha J. Ellis

  3. Department of Neuroscience, Monash University, Melbourne, Australia

    Helen Kavnoudias, Gideon Blecher & Adil Zia

  4. Department of Urology, Alfred hospital, Melbourne, Australia

    Heather K. Moriarty, Helen Kavnoudias, Gideon Blecher, Adil Zia, Warren Clements, Gerard S. Goh, Samantha J. Ellis & Tuan Phan

  5. Australian and New Zealand Society of Thoracic Radiology, Monash University, Melbourne, Australia

    Samantha J. Ellis

Authors
  1. Heather K. Moriarty
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  2. Helen Kavnoudias
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  3. Gideon Blecher
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  4. Adil Zia
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  6. Gerard S. Goh
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  7. Samantha J. Ellis
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  8. Tuan Phan
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Corresponding author

Correspondence to Heather K. Moriarty.

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The authors declare that they have no conflict of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was performed in accordance with guidelines from the Alfred Hospital Research and Ethics Committee. This material is not under submission elsewhere. Ethical approval by the Hospital Research and Ethics Committee has been granted, Project No: 354/20.

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Moriarty, H.K., Kavnoudias, H., Blecher, G. et al. PIVET-ED: A Prospective, Randomised, Single-Blinded, Sham Controlled Study of Pelvic Vein Embolisation for Treatment of Erectile Dysfunction. Cardiovasc Intervent Radiol 45, 155–161 (2022). https://doi.org/10.1007/s00270-021-03021-x

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  • DOI: https://doi.org/10.1007/s00270-021-03021-x

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