TY - JOUR
T1 - The Butterfly
T2 - A Novel Minimally Invasive Transurethral Retraction Device for Benign Hypertrophy of the Prostate
AU - Katz, Ran
AU - Ahmed, Muhamad Sabih Abu
AU - Safadi, Ali
AU - Roizman, Shmuel
AU - Zisman, Amnon
AU - Kabha, Maharan
AU - Dekel, Yoram
AU - Baniel, Jack
AU - Aharony, Shachar
N1 - Publisher Copyright:
© 2023 The Author(s). Published by S. Karger AG, Basel. This article is licensed under the Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC). Usage and distribution for commercial purposes requires written permission.
PY - 2023/5/1
Y1 - 2023/5/1
N2 - Introduction: 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. Materials and Methods: 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. Results: 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. Conclusions: We demonstrated feasibility and good tolerability of the Butterfly device.
AB - Introduction: 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. Materials and Methods: 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. Results: 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. Conclusions: We demonstrated feasibility and good tolerability of the Butterfly device.
KW - Benign prostatic hyperplasia
KW - Bladder outlet obstruction
KW - Lower urinary tract symptoms
KW - Minimally invasive surgical therapy
KW - Urethral devices
UR - http://www.scopus.com/inward/record.url?scp=85149110799&partnerID=8YFLogxK
U2 - 10.1159/000528415
DO - 10.1159/000528415
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C2 - 36720211
AN - SCOPUS:85149110799
SN - 0042-1138
VL - 107
SP - 406
EP - 412
JO - Urologia Internationalis
JF - Urologia Internationalis
IS - 4
ER -