Head, department of Urology Azrieli faculty of medicine, Bar Ilan university, Safed, Israel
Introduction: The Butterfly Prostatic Retraction Device is a novel minimally invasive implant that is delivered into the prostatic urethra in order to retract the lateral lobes of the prostate and treat symptoms associated with BPH.
The device is made of nitinol and consists of two lateral wings connected by transverse rails and is available in five sizes. It is folded into a 5 mm introducer, inserted via rigid cystoscopy and deployed in the prostatic urethra between the verumontanum and the bladder neck. In body temperature the device expands and pushes the prostate lobes laterally, opening a wide path in the prostatic urethra while preserving the bladder neck. It is designed for day surgery or in office settings. We present mid-term results our results in the management of men suffering from BPH.
Methods: A prospective, Open-Label clinical study for assessing the safety and efficacy of the Butterfly device in male patients suffering from LUTS due to BPH was performed enrolling up to date 64 men, all treated for BPH for at least one year and were candidates for prostatectomy. All patients had Qmax= 13 ml/sec and IPSS > 12.
Patients with previous prostate procedure, prostatitis, cystolithiasis, prostate median lobe, urethral/bladder neck stricture and atonic bladder were excluded. The study was approved by the hospitals’ IRBs.
Insertion of the device was performed under sedation in a day care setting. No catheter was left. 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. Follow up period ranged from 4 to 35 months. 28 patients completed a minimum of 1 year follow up with an intact device.
The mean improvement in Qmax was 2 ml/sec (25%) in 12 months. Mean PVR was 112 ml on baseline and decreased to 85.7 ml in 12 months (25.9% decrease)
Mean IPSS score was 25 on baseline and 15 after 12 months (40% decrease). 71.4% of the patients had an IPSS decrease of more than 3 points.
The mean improvement of QoL was 1.5 points (38%).
No patient reported deterioration of sexual function and all sexually active patients reported antegrade ejaculation.
On cystoscopy, gradual coverage of the device with urethral mucosa was observed and there were no cases of encrustation.
Peri-operatively, 3Â out of 64 patients had a Clavien Dindo grade 3a complication (urinary retention requiring suprapubic drainage). In one patient the device was re-positioned. Twelve patients elected to remove the device and returned to alpha blocker therapy. Seven patients underwent TURP. One patient developed a bulbar urethral stricture.
Conclusions: The butterfly device is simple and efficient minimally invasive device for the management of LUTS due to BPH with a low complication rate, comparable to other minimally invasive devices, and good tolerability.
Source of Funding: Butterfly Medical Inc. - Yoqneam, Israel
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