Presented by: Ran Katz MD
Ziv Medical Center, Safed, Israel

Introduction

To assess the effectiveness of the Butterfly device and its effect on LUTS.

Materials

The Butterfly device was implanted as part of a multi-center clinical trial performed in Israel. It included so far 92 men who were treated for at least one year for BPH and were candidates for TURP with a Qmax ˂ 13 ml/sec and an IPSS score ˃ 12.

The device was inserted through cystoscopy under local anesthesia and sedation. No catheter was left. Follow up assessment included uroflowmetry, IPSS, QoL and sexual questionnaires. Patients whose score on questions 1,3,5,6 of the IPSS was higher than the score of questions 2,4,7 were defined as predominantly obstructed. Response to intervention was defined as at least 4 points improvement in the IPSS.

This paper focus on the last 20 patients who were predominantly obstructed

Results

,

Patients' mean age was 68 (50-82). Maximal follow-up period was 4.5 years. Looking specifically the last 20 predominantly obstructed patients, Qmax improvement was 42% and IPSS improvement 40%.  The intervention response rate was 86% at 3 and 12 months. 

No patient reported deterioration of sexual function and sexually active patients reported antegrade ejaculation. Adverse events were mainly Clavien-Dindo 1-2. only 3 devices were removed

Conclusion

The butterfly device is effective in the management of BPH with good tolerability and a low rate of complications with an excellent response rate in predominantly obstructed patients. 

Funding

Butterfly Medical - Yoqneam, Israel 

Co-Authors

Ali Safadi, MD
Ziv Medical Center

Muhammd Abu Ahmed, MD
Ziv Medical Center

shmuel Roizman, MD
Shamir Medical Center

Amnon Zisman, MD
Shamir medical center

Mahran Kabha, MD
Carmel Medical Center

Yoram Dekel, MD
Carmel Medical Center

Jack Baniel, MD
Rabin Medical Center

Shachar Aharoni, MD
Rabin