PD23-06 12-MONTH INTERIM RESULTS OF THE MULTICENTER, PROSPECTIVE, SINGLE-ARM STUDY WITH THE ZENFLOW SPRING SYSTEM: A NOVEL MINIMALLY-INVASIVE TREATMENT FOR LUTS ASSOCIATED WITH BPH

Abstract

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology IV (PD23)1 Sep 2021PD23-06 12-MONTH INTERIM RESULTS OF THE MULTICENTER, PROSPECTIVE, SINGLE-ARM STUDY WITH THE ZENFLOW SPRING SYSTEM: A NOVEL MINIMALLY-INVASIVE TREATMENT FOR LUTS ASSOCIATED WITH BPH Peter Gilling, Janelle Brennan, Peter Chin, Lauro Salvador Gomez Guerra, Rodrigo Perez Becerra, and Juan José Galán Maraboto Peter GillingPeter Gilling More articles by this author , Janelle BrennanJanelle Brennan More articles by this author , Peter ChinPeter Chin More articles by this author , Lauro Salvador Gomez GuerraLauro Salvador Gomez Guerra More articles by this author , Rodrigo Perez BecerraRodrigo Perez Becerra More articles by this author , and Juan José Galán MarabotoJuan José Galán Maraboto More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002016.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The Zenflow Spring System (Zenflow, Inc., South San Francisco, CA, USA) is a minimally-invasive treatment for LUTS secondary to BPH, delivered transurethrally to the prostatic urethra through a custom flexible system. The 12-month interim analysis of 42 subjects enrolled in a multicenter, prospective, single-arm evaluation of safety, performance, and effectiveness of the Zenflow Spring System in relieving symptoms of BPH, are presented below. METHODS: The study included subjects ≥45 years of age with baseline IPSS score ≥13, QoL score ≥3, and prostate volume 25-80 cc. Follow-up assessments for effectiveness and safety were conducted at 2 weeks, 1, 3, 6, and 12 months and will continue annually through 60 months. RESULTS: Procedural success was achieved in 90% (38/42) of subjects enrolled. 12-month follow up data for 35 subjects is presented below. These subjects experienced statistically significant improvements in IPSS, QoL, and peak flow rate at all time points, through 12 months. Cystoscopy was performed at 3 and 12 months post implant with no evidence of encrustation. Reports of pain were few, mild, and transient. There was no impact on sexual function nor reports of ejaculatory dysfunction. Most patients did not require postoperative catheterization outside of standard of care treatment. Six SAEs were reported in 6 subjects. Four occurred in roll-in subjects who were among the first to receive treatment with the new generation of the device. It is highly probable these events are tied to the learning curve. Five subjects were explanted over the course of 12 months: 3 subjects due to urinary retention, 2 for lack of effectiveness and 1 for unrelated ureter carcinoma that prevented continuation in the trial. CONCLUSIONS: 12-month interim results suggest that the Zenflow Spring System provides a rapid and durable improvement in BPH symptoms and patient quality of life. Source of Funding: Study was funded solely by the study sponsor, Zenflow, Inc © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e422-e422 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Peter Gilling More articles by this author Janelle Brennan More articles by this author Peter Chin More articles by this author Lauro Salvador Gomez Guerra More articles by this author Rodrigo Perez Becerra More articles by this author Juan José Galán Maraboto More articles by this author Expand All Advertisement PDF downloadLoading ...