The Butterfly: A Novel Minimally Invasive Transurethral Retraction Device for Benign Hypertrophy of the Prostate.

"Conflict of Interest Statement The authors have no conflicts of interest to declare."

"This study was fully funded by Butterfly Medical Ltd. Yoqneam, Israel. The coverage included all hospitalization costs as well as the device itself. Patients or their medical insurance did not pay anything in this study. The company and it's representatives did not take any part in preparing this manuscript."

"The study was approved by the hospitals' IRBs (0073-17-ZIV) and registered in Clinical Trials.gov (NCT 03912558). We enrolled men above 50 years of age, treated for BPH for at least 1 year, with a prostate size between 30 and 110 g, Qmax below 13 mL/s, and IPSS score above 12. All patients were eligible candidates for prostate surgery but elected to take part in the study. No patient suffered from urinary retention, and no patient had an indwelling catheter. We excluded patients with active prostatitis, urethral or bladder neck pathology, enlarged median lobe, previous prostate surgery, and atonic bladder. All patients signed an informed consent form before entering the study. Patients were followed for a period of 1 year after insertion of the device. The study's objectives were assessment of the safety and efficacy of the Butterfly, assessment of life quality, sexual and ejaculatory function, and visual assessment of the device's position and encrustation status."