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

Egils Vjaters; David Nitsan; Michael Mullerad; Dov Engelstein; Ilan Leibovitch; Yair Feld

doi:10.1016/j.euf.2018.09.013

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

Egils Vjaters
, David Nitsan
, Michael Mullerad
, Dov Engelstein
, Ilan Leibovitch
, Yair Feld

Paula Stradina Clinical University Hospital
ProArc Medical Ltd
Rambam Health Care Campus
Western Galilee Medical Center of Nahariya
Meir Hospital Sapir Medical Center

Research output: Contribution to journal › Article › peer-review

13 Scopus citations

Abstract

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 to BPH, involving implantation of a C-shaped nitinol ring (ClearRing) in a circular incision in the prostatic tissue using an electrocuting 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 (Q_max), 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 implant in 28 patients and two implants in one patient. No serious complications occurred. Patients experienced symptom relief by 3 mo that was sustained to 12 mo. Mean IPSS, QOL, and Q_max improved by 45%, 41%, and 40% by 3 mo, and 53%, 52%, and 49% by 12 mo, respectively (p < 0.05). Adverse events were mild and transient. There were no reports of loss of antegrade ejaculation or any effects on erectile function. Implantation positioning failed in 11/29 patients, who then underwent uneventful TURP. After modification of the 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.

Original language	English
Pages (from-to)	131-136
Number of pages	6
Journal	European Urology Focus
Volume	6
Issue number	1
DOIs	https://doi.org/10.1016/j.euf.2018.09.013
State	Published - 15 Jan 2020
Externally published	Yes

Bibliographical note

Publisher Copyright:
© 2018 European Association of Urology

Funding

This study demonstrated the 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. Author contributions: Yair Feld had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Feld, Nitsan, Leibovitch. Acquisition of data: Vjaters, Mullerad, Engelstein. Analysis and interpretation of data: Feld, Vjaters, Leibovitch. Drafting of the manuscript: Feld. Critical revision of the manuscript for important intellectual content : Leibovitch. Statistical analysis: Feld. Obtaining funding: Nitsan, Feld. Administrative, technical, or material support: None. Supervision: None. Other: None. Financial disclosures: Yair Feld certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Yair Feld is a founder of and David Nitsan is an employee of ProArc Medical. The remaining authors have nothing to disclose. Funding/Support and role of the sponsor: This work was supported by ProArc Medical . The sponsor played a role in the design and conduct of the study; data management, analysis, and interpretation; and manuscript preparation, review, and approval.

Funders
ProArc Medical

Keywords

Benign prostatic hyperplasia
Endoscopy
Surgical devices

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10.1016/j.euf.2018.09.013

Cite this

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

abstract = "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 to BPH, involving implantation of a C-shaped nitinol ring (ClearRing) in a circular incision in the prostatic tissue using an electrocuting 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{\textendash}50 cm3, and IPSS was 21.6. All procedures were successfully completed with one implant in 28 patients and two implants in one patient. No serious complications occurred. Patients experienced symptom relief by 3 mo that was sustained to 12 mo. Mean IPSS, QOL, and Qmax improved by 45\%, 41\%, and 40\% by 3 mo, and 53\%, 52\%, and 49\% by 12 mo, respectively (p < 0.05). Adverse events were mild and transient. There were no reports of loss of antegrade ejaculation or any effects on erectile function. Implantation positioning failed in 11/29 patients, who then underwent uneventful TURP. After modification of the 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.",

keywords = "Benign prostatic hyperplasia, Endoscopy, Surgical devices",

author = "Egils Vjaters and David Nitsan and Michael Mullerad and Dov Engelstein and Ilan Leibovitch and Yair Feld",

note = "Publisher Copyright: {\textcopyright} 2018 European Association of Urology",

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AU - Vjaters, Egils

AU - Nitsan, David

AU - Mullerad, Michael

AU - Engelstein, Dov

AU - Leibovitch, Ilan

AU - Feld, Yair

PY - 2020/1/15

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N2 - 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 to BPH, involving implantation of a C-shaped nitinol ring (ClearRing) in a circular incision in the prostatic tissue using an electrocuting 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 implant in 28 patients and two implants in one patient. No serious complications occurred. Patients experienced symptom relief by 3 mo that was sustained to 12 mo. Mean IPSS, QOL, and Qmax improved by 45%, 41%, and 40% by 3 mo, and 53%, 52%, and 49% by 12 mo, respectively (p < 0.05). Adverse events were mild and transient. There were no reports of loss of antegrade ejaculation or any effects on erectile function. Implantation positioning failed in 11/29 patients, who then underwent uneventful TURP. After modification of the 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.

AB - 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 to BPH, involving implantation of a C-shaped nitinol ring (ClearRing) in a circular incision in the prostatic tissue using an electrocuting 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 implant in 28 patients and two implants in one patient. No serious complications occurred. Patients experienced symptom relief by 3 mo that was sustained to 12 mo. Mean IPSS, QOL, and Qmax improved by 45%, 41%, and 40% by 3 mo, and 53%, 52%, and 49% by 12 mo, respectively (p < 0.05). Adverse events were mild and transient. There were no reports of loss of antegrade ejaculation or any effects on erectile function. Implantation positioning failed in 11/29 patients, who then underwent uneventful TURP. After modification of the 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.

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KW - Endoscopy

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

Abstract

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Keywords

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