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First-in-man Safety and Efficacy of the ClearRing Implant for the Treatment of Benign Prostatic Hyperplasia

  • Egils Vjaters 1,
  • David Nitsan 2,
  • Michael Mullerad 3,
  • Dov Engelstein 4,
  • Ilan Leibovitch 5,
  • Yair Feld 2
1 Department of Urology, Pauls Stradins Clinical University Hospital, Riga, Latvia 2 ProArc Medical, Caesarea, Israel 3 Department of Urology, Rambam Health Care Campus, Haifa, Israel 4 Department of Urology, Galilee Medical Center, Nahariya, Israel 5 Department of Urology, Meir Medical Center, Kfar-Saba, Israel

Publication: , September 2018

Background

Although effective for benign prostatic hyperplasia (BPH), transurethral resection of the prostate (TURP) can be associated with side effects including prolonged recovery, storage and voiding symptoms, and a risk of acute urinary retention.

Objective 
To test a new minimally invasive device for the treatment of lower urinary tract symptoms (LUTS) due toBPH, involvingimplantationofa C-shaped nitinol ring (ClearRing) in acircular incisionin theprostatic tissueusing anelectrocuting blade over a dilatation balloon.

Design, setting, and participants
This was a multicenter single-arm clinical trial involving 29 men with severe symptomatic BPH.

Intervention
Implantation of a ClearRing device under regional anesthesia.

Outcome measurements and statistical analysis
Effectiveness in alleviating LUTS was assessed in terms of International Prostate Symptom Score (IPSS) at baseline and 3, 6, and 12 mo after the procedure. To evaluate changes from baseline, a general estimating equation model was fitted to IPSS, the Quality of Life (QOL) scale, Benign Prostatic Hyperplasia Impact Index, maximum flow rate (Qmax), and postvoid residual volume. Statistical significance was defined as p < 0.05.

Results and limitations
The average age was 71.4 yr, prostate size was 35–50 cm3, and IPSS was 21.6. All procedures were successfully completed with one implantin 28 patients and two implants in one patient. No serious complications occurred. Patients experienced symptom reliefby3mo thatwas sustained to 12mo. Mean IPSS,QOL,andQmax improved by 45%,41%, and40%by3mo, and53%,52%,and49% by12mo, respectively(p < 0.05). Adverse events were mild and transient. There were no reports of loss of antegrade ejaculation or anyeffects onerectile function.Implantation positioning failed in11/29patients, whothen underwent uneventful TURP. After modification ofthe delivery device,the success rate for implant positioning improved from 5/13 patients to 13/16 patients. Study limitations include the single-arm nature and the low patient number.

Conclusions
We demonstrated preliminary feasibility of the ClearRing device for minimally invasive treatment of BPH in men. Further studies are needed to confirm the safety and efficacy of this approach.

Patient summary
In this study we tested outcomes after implantation of a ClearRing device in patients with benign prostatic hyperplasia. We found that the device was safe and effective. However, there was a high rate of implantation failure due to malpositioning, which was significantly improved following modification of the delivery device.

Tags: BPH