Head, department of Urology Azrieli faculty of medicine, Bar Ilan university, Safed, Israel
Introduction: To assess the safety and effectiveness of the Butterfly device and its effect on LUTS and ejaculation and the impact of the learning curve. Methods: The study was approved by the Hospital's IRBs. A prospective clinical trial was conducted among 77 men who were treated for at least one year for BPH and were candidates for TURP prior to the intervention. All patients had a Qmax below 13 ml/sec and an IPSS score above 12. The device was inserted through cystoscopy under local anesthesia and sedation. No catheter was left. Follow up assessment was conducted after 2 weeks, 1,3,6,9, and 12 months and then semiannually and included uroflowmetry, IPSS, QoL and sexual questionnaires. Cystoscopy was performed on 3 and 12 months. An analysis of the last 21 consecutive cases was performed and compared to the overall results of the series. Results: Patients' mean age was 68 (50-82). 48 patients completed 1 year follow up with an intact device. The maximal follow-up period was 3.5 years. The average Qmax improvement was 1.4 ml/sec (25%), Average IPSS score decrease was 9.6 points (38.2%), and QoL score improved by 5.1 points (38%). Average PVR decreased by 25.2%. No patient reported deterioration of sexual function and sexually active patients reported antegrade ejaculation. Cystoscopy demonstrated gradual coverage of the device by the prostatic mucosa. Three patients underwent re-positioning of the device. Adverse events were mild, mainly Clavien-Dindo 1-2. One patient developed a bulbar urethral stricture. 24 patients (31%) had their device removed, and 7 of them subsequently underwent TURP. Comparing the last 21 patients in the series, their average age was 68 years, their improvement was identical to the general series yet only 3 devices (14%) were removed and no patient required prostate surgery. Mean age Prior BPH years Prostatic urethral length (cm) 12M Qmax Ml/sec % improvement (compared to baseline) PVR (ML) % improvement (compared to baseline Extractions N (%) All patients 68 7.2 2.88 10.5 25.0 % 87.8 25.2% 24 (31%) Last 21 68 6 2.84 10.3 28.7% 88.3 31.1% 3 (14%) Conclusions: The butterfly device is safe and effective in the management of BPH with good tolerability and a low rate of complications. The gathered experience in this procedure resulted in significant improvement of the clinical outcome of the patients. SOURCE OF Funding: Butterfly Medical Ltd. Yoqneam, IL
