The Butterfly Prostatic Retraction device is a novel transurethral implant designed to dilate the prostatic urethra and treat lower urinary tract symptoms. We assessed its safety, efficacy and impact on urinary flow, ejaculation, and quality of life.
We included 64 men, treated for benign prostate hyperplasia for at least 1 year. All patients had Qmax≤ 13 mL/s and IPSS >12. Insertion of the device was performed via cystoscopy. 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.
Patients age was 50-83 years. 28 patients completed a 1-year follow-up with an intact device. Mean Qmax improved by 2 mL/s (25%), IPSS median drop was 10 points (40%), and QoL score was 1.5 points (38%). Sexually active patients reported antegrade ejaculation. On cystoscopy, gradual coverage of the devices with urethral mucosa was observed. In 1 patient, the device was repositioned. In 19 patients, the device was removed. 12 patients returned to alpha-blocker therapy and 7 patients underwent TURP. One patient developed a bulbar urethral stricture.
We demonstrated feasibility and good tolerability of the Butterfly device.
Urologia internationalis. 2023 Jan 31 [Epub ahead of print]
Ran Katz, Muhamad Sabih Abu Ahmed, Ali Safadi, Shmuel Roizman, Amnon Zisman, Maharan Kabha, Yoram Dekel, Jack Baniel, Shachar Aharony
Department of Urology, Ziv Medical Center, Azriell Faculty of Medicine, Bar Ilan University, Safed, Israel., Department of Urology, Shamir Medical Center, Tel Aviv University Faculty of Medicine, Zrifin, Israel., Department of Urology, Carmel Medical Center, Technion Faculty of Medicine, Haifa, Israel., Department of Urology, Rabin Medical Center, Tel Aviv University Faculty of Medicine, Petach Tikva, Israel.