Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers

Summary

This prospective randomized controlled trial (RCT) is designed to provide high level evidence on the efficacy of Low-intensity Extracorporeal Shock Wave Therapy (Li-ESWT) in the treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) erectile dysfunction (ED) in addition to PDE5 inhibitors (PDE5i) versus PDE5i alone. Our hypothesis is that early andrological rehabilitation that combines Li-ESWT and PDE5i could lead to faster and better recovery of valid erections for intercourse, with a greater rate of postoperative International Index of Erectile Function-5 (IIEF-5) compared to patients receiving PDE5i alone.

Timeline

Start

2024-08-31

Primary completion

2025-08-31

Completion

2026-08-31

Publications

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• Background Lin G, Reed-Maldonado AB, Wang B, Lee YC, Zhou J, Lu Z, Wang G, Banie L, Lue TF. In Situ Activation of Penile Progenitor Cells With Low-Intensity Extracorporeal Shockwave Therapy. J Sex Med. 2017 Apr;14(4):493-501. doi: 10.1016/j.jsxm.2017.02.004. Epub 2017 Mar 1.
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• Background Becker M, Goetzenich A, Roehl AB, Huebel C, de la Fuente M, Dietz-Laursonn K, Radermacher K, Rossaint R, Hein M. Myocardial effects of local shock wave therapy in a Langendorff model. Ultrasonics. 2014 Jan;54(1):131-6. doi: 10.1016/j.ultras.2013.07.005. Epub 2013 Jul 12.
• Background Rassweiler JJ, Knoll T, Kohrmann KU, McAteer JA, Lingeman JE, Cleveland RO, Bailey MR, Chaussy C. Shock wave technology and application: an update. Eur Urol. 2011 May;59(5):784-96. doi: 10.1016/j.eururo.2011.02.033. Epub 2011 Feb 23.
• Background Chung E, Cartmill R. Evaluation of clinical efficacy, safety and patient satisfaction rate after low-intensity extracorporeal shockwave therapy for the treatment of male erectile dysfunction: an Australian first open-label single-arm prospective clinical trial. BJU Int. 2015 Apr;115 Suppl 5:46-9. doi: 10.1111/bju.13035.
• Background Abu-Ghanem Y, Kitrey ND, Gruenwald I, Appel B, Vardi Y. Penile low-intensity shock wave therapy: a promising novel modality for erectile dysfunction. Korean J Urol. 2014 May;55(5):295-9. doi: 10.4111/kju.2014.55.5.295. Epub 2014 May 12.
• Background Teloken P, Mesquita G, Montorsi F, Mulhall J. Post-radical prostatectomy pharmacological penile rehabilitation: practice patterns among the international society for sexual medicine practitioners. J Sex Med. 2009 Jul;6(7):2032-8. doi: 10.1111/j.1743-6109.2009.01269.x. Epub 2009 Apr 23.
• Background Hatzichristou D, d'Anzeo G, Porst H, Buvat J, Henneges C, Rossi A, Hamidi K, Buttner H. Tadalafil 5 mg once daily for the treatment of erectile dysfunction during a 6-month observational study (EDATE): impact of patient characteristics and comorbidities. BMC Urol. 2015 Nov 12;15:111. doi: 10.1186/s12894-015-0107-5.
• Background Corbin JD. Mechanisms of action of PDE5 inhibition in erectile dysfunction. Int J Impot Res. 2004 Jun;16 Suppl 1:S4-7. doi: 10.1038/sj.ijir.3901205.
• Background Ficarra V, Novara G, Ahlering TE, Costello A, Eastham JA, Graefen M, Guazzoni G, Menon M, Mottrie A, Patel VR, Van der Poel H, Rosen RC, Tewari AK, Wilson TG, Zattoni F, Montorsi F. Systematic review and meta-analysis of studies reporting potency rates after robot-assisted radical prostatectomy. Eur Urol. 2012 Sep;62(3):418-30. doi: 10.1016/j.eururo.2012.05.046. Epub 2012 Jun 1.
• Background Philippou YA, Jung JH, Steggall MJ, O'Driscoll ST, Bakker CJ, Bodie JA, Dahm P. Penile rehabilitation for postprostatectomy erectile dysfunction. Cochrane Database Syst Rev. 2018 Oct 23;10(10):CD012414. doi: 10.1002/14651858.CD012414.pub2.
• Background Dearnaley DP, Jovic G, Syndikus I, Khoo V, Cowan RA, Graham JD, Aird EG, Bottomley D, Huddart RA, Jose CC, Matthews JH, Millar JL, Murphy C, Russell JM, Scrase CD, Parmar MK, Sydes MR. Escalated-dose versus control-dose conformal radiotherapy for prostate cancer: long-term results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2014 Apr;15(4):464-73. doi: 10.1016/S1470-2045(14)70040-3. Epub 2014 Feb 26.
• Background Sivarajan G, Prabhu V, Taksler GB, Laze J, Lepor H. Ten-year outcomes of sexual function after radical prostatectomy: results of a prospective longitudinal study. Eur Urol. 2014 Jan;65(1):58-65. doi: 10.1016/j.eururo.2013.08.019. Epub 2013 Aug 26.
• Background Limoncin E, Gravina GL, Corona G, Maggi M, Ciocca G, Lenzi A, Jannini EA. Erectile function recovery in men treated with phosphodiesterase type 5 inhibitor administration after bilateral nerve-sparing radical prostatectomy: a systematic review of placebo-controlled randomized trials with trial sequential analysis. Andrology. 2017 Sep;5(5):863-872. doi: 10.1111/andr.12403. Epub 2017 Aug 8.

Drugs

Indications