PD18-11 THE "BUTTERFLY", A NOVEL MINIMALLY INVASIVE TRANSURETHRAL RETRACTION DEVICE FOR BPH

Abstract

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology III (PD18)1 Sep 2021PD18-11 THE "BUTTERFLY", A NOVEL MINIMALLY INVASIVE TRANSURETHRAL RETRACTION DEVICE FOR BPH Ran Katz, Ali Safadi, Muhamad Abu Ahmed, Shmuel Roizman, Amnon Zisman, Maharan Kabha, Yoram Dekel, Jack Baniel, and shachar Aharoni Ran KatzRan Katz More articles by this author , Ali SafadiAli Safadi More articles by this author , Muhamad Abu AhmedMuhamad Abu Ahmed More articles by this author , Shmuel RoizmanShmuel Roizman More articles by this author , Amnon ZismanAmnon Zisman More articles by this author , Maharan KabhaMaharan Kabha More articles by this author , Yoram DekelYoram Dekel More articles by this author , Jack BanielJack Baniel More articles by this author , and shachar Aharonishachar Aharoni More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002007.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The Butterfly Prostatic Retraction Device is a novel minimally invasive, non-surgical implant that is delivered into the prostatic urethra in order to retract the lateral lobes of the prostate, increase the diameter of the prostatic urethra thus treating symptoms associated with BPH. The device is made of nitinol and consists of two lateral wings connected by several transverse rails and is available in five sizes. It is folded into a 5 mm introducer, inserted via rigid cystoscopy and deployed in the prostatic urethra between the verumontanum and the bladder neck. In body temperature the device expands, pushes the prostate lobes laterally, opening a wide path in the prostatic urethra while preserving the bladder neck. It is designed for day surgery or in office settings. We present our results in the management of men suffering from BPH. METHODS: A prospective, Open-Label clinical study for assessing the safety and efficacy of the Butterfly device in male patients suffering from LUTS due to BPH was performed enrolling up to date 50 men who were treated for BPH for at least one year and were candidates for prostatectomy. All patients had Qmax≤ 13 ml/sec and IPSS > 12. Patients with previous prostate procedure, prostatitis, cystolithiasis, prostate median lobe, urethral/bladder neck stricture and atonic bladder were excluded. The study was approved by the hospitals’ IRBs. Insertion of the device was performed under sedation in a day care setting. No catheter was left. Follow up visits were performed at 2 weeks, 1, 3, 6, and 12 months and included uroflowmetry, IPSS, QoL and sexual function questionnaires. Cystoscopy was performed on 3 and 12 months. RESULTS: Patient age range was 50-82 years. 23 patients completed a 1 year follow up and median follow up was 9 months. In one-year Qmax improved by 33%, IPSS score by 40% and QoL score improved by 38% compared to baseline. No patient reported deterioration of sexual function and all sexually active patients reported antegrade ejaculation. On cystoscopy, gradual coverage of the device with urethral mucosa was observed and there were no cases of encrustation. No unanticipated device related AE occurred. In one patient the device was re-positioned. Five patients elected to remove the device and returned to alpha blocker therapy. Seven patients underwent TURP. One patient developed a bulbar urethral stricture. CONCLUSIONS: The butterfly device is simple and efficient minimally invasive device for the management of LUTS due to BPH with a low complication rate, comparable to other minimally invasive devices, and good tolerability. Source of Funding: Butterfly Medical - Yokneam, Israel © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e359-e359 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ran Katz More articles by this author Ali Safadi More articles by this author Muhamad Abu Ahmed More articles by this author Shmuel Roizman More articles by this author Amnon Zisman More articles by this author Maharan Kabha More articles by this author Yoram Dekel More articles by this author Jack Baniel More articles by this author shachar Aharoni More articles by this author Expand All Advertisement PDF downloadLoading ...