Pd52-12 Low-Intensity Extracorporeal Shockwave Therapy Is Safe in the Immediately Following Robotic-Assisted Radical Prostatectomy (Nct03862599)

You have accessJournal of UrologySexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy II (PD52)1 May 2024PD52-12 LOW-INTENSITY EXTRACORPOREAL SHOCKWAVE THERAPY IS SAFE IN THE IMMEDIATELY FOLLOWING ROBOTIC-ASSISTED RADICAL PROSTATECTOMY (NCT03862599) Findlay E. N. MacAskill, Piotr Sluzar, Ibrahim Samy, Maria Bertononcelli Tanaka, Matthew Megson, Hasan Qazi, Tet Yap, and Guy's Post Pelvic Surgery Research Group Findlay E. N. MacAskillFindlay E. N. MacAskill , Piotr SluzarPiotr Sluzar , Ibrahim SamyIbrahim Samy , Maria Bertononcelli TanakaMaria Bertononcelli Tanaka , Matthew MegsonMatthew Megson , Hasan QaziHasan Qazi , Tet YapTet Yap , and Guy's Post Pelvic Surgery Research Group View All Author Informationhttps://doi.org/10.1097/01.JU.0001009412.04863.1b.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Erectile dysfunction following robotic-assisted radical prostatectomy (RARP) is a major contribution to treatment regret. Low-intensity extracorporeal shockwave therapy (Li-ESWT) has gained popularity but there remains a paucity of data for its use post-RARP. There is no data on oncological safety to deliver shockwaves to the perineum following pelvic surgery. Biochemical recurrence rates are reported at 20-40% following RARP. We present our initial safety data for patients treated with Li-ESWT immediately following RARP. METHODS: This multi-centre double-blinded, randomised sham-controlled trial (NCT03862599) has a 1:1 ratio between machine A or B. Patients aged 40-65, with organ-confined, low-intermediate risk prostate cancer that underwent bilateral incremental or full nerve sparing surgery and with good pre-operative erectile function were invited to be recruited. The Storz Medical Duolith SD1 T-TOP machine was used for treatments starting within 7 days of the removal of urinary catheter (with 2-3 weeks following surgery). Patients were treated once a week for 12 weeks in combination with daily dose tadalafil. Biochemical recurrence was defined as PSA >0.2 ng/L and if initial PSA reached this level patients were immediately withdrawn. RESULTS: We report on our initial 40 patients. In group A, there were 20 (11 Black and 9 White) patients with mean age 55 years and pre-operative PSA 7.2. One patient had Gleason 3+3, 15 patients had Gleason 3+4, 3 patients had Gleason 4+3 and 1 patient had Gleason 4+4. In group B, there were also 20 (11 White and 9 Black) patients, with mean age 55 years and pre-operative PSA 7.6. 18 patients had Gleason 3+4, one patient had Gleason 4+3 and one did not have cancer. In group A, 18 patients have completed 1 year follow up. Two have completed 6 months follow up. There were no biochemical recurrences in group A, with only one detectable PSA 0.04 ng/l at 1 year in 1 patient. In group B, 16 patients had completed 1 year follow up. Four patients also completed 6 month follow up. There was one biochemical recurrence at 1 year in this group (5% rate) but his nadir only reached 0.06 ng/L. There were no adverse events because of Li-ESWT treatment in either group. CONCLUSIONS: Li-ESWT is safe in the immediate post-operative period following RARP in respect of oncological outcomes, with biochemical recurrence rates below reported in the literature. There were no significant adverse events. We will report Li-ESWT efficacy following completion of our trial, as more data regarding the efficacy is required. Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1076 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Findlay E. N. MacAskill More articles by this author Piotr Sluzar More articles by this author Ibrahim Samy More articles by this author Maria Bertononcelli Tanaka More articles by this author Matthew Megson More articles by this author Hasan Qazi More articles by this author Tet Yap More articles by this author Guy's Post Pelvic Surgery Research Group More articles by this author Expand All Advertisement PDF downloadLoading ...