이식형 결찰사를 이용한 전립선 결찰술

Abstract

평가 배경 이식형 결찰사를 이용한 전립선 결찰술(Prostatic Urethral Lift, PUL)은 전립선 비대증 환자 중 50세 이상이고 전립선 용적이 100cc 미만인 환자를 대상으로 비대해진 전립선 조직을 이식형 결찰사를 이용하여 영구적으로 묶어줌으로써 요도를 넓혀 요도폐색을 치료해주는 시술이다. 해당 의료기술은 2015년 5월 신의료기술평가위원회에서 안전성 및 효과적인 시술로 평가되어 2016년에 행위비급여로 등재되어 현재까지 사용되고 있다. 해당 의료기술은 내부모니터링을 통해 발굴된 주제로, 대상선별 임상자문회의 및 우선순위심의에서 재평가 주제로 적합성 및 필요성이 확인되어 2021년 9차 의료기술재평가위원회(2021.9.10.)에서 의료기술재평가 대상으로 선정되었다. 본 평가에서는 ‘이식형 결찰사를 이용한 전립선 결찰술’의 적정사용 등 정책적 의사결정을 지원하기 위하여 해당 의료기술의 임상적 안전성, 효과성 등에 대한 의과학적 근거를 확인하고자 한다.

평가 방법 이식형 결찰사를 이용한 전립선 결찰술의 안전성 및 효과성 평가를 위해 체계적 문헌고찰을 수행하였다. 모든 평가방법은 평가목적을 고려하여 “이식형 결찰사를 이용한 전립선 결찰술 소위원회(이하 ‘소위원회’라 한다)”의 심의를 거쳐 확정하였다. 해당 소위원회는 비뇨의학과 3인, 근거기반의학 1인의 전문가 4인으로 구성하였다. 핵심질문은 “전립선 비대증 환자를 대상으로 이식형 결찰사를 이용한 전립선 결찰술 시행은 임상적으로 안전하고 효과적인가?”이었고, 동 기술의 비교기술로 경요도적 전립선절제술(Transurethral resection of the prostate, TURP), 홀뮴 레이저를 이용한 전립선 광적출술(Holmium Laser Enucleation of the Prostate, HoLEP), 전립선동맥색전술, Sham 시술을 포함하였다. 안전성은 시술관련 부작용 및 합병증으로 평가하였으며, 출혈관련 합병증, 심폐합병증, 감염, 통증, 요폐, 부작용 및 합병증으로 인한 도뇨관 삽입률 및 삽입기간, 부작용 및 합병증으로 인한 추가중재의 요구도를 포함하였다. 효과성은 전립선 비대증 증상개선 정도, 요역동학적 효과, 효과 미흡으로 인한 도뇨관 삽입률 및 삽입기간, 성기능 장애, 효과 미흡으로 인한 추가중재의 요구도를 기준으로 평가하였다. 체계적 문헌고찰은 핵심질문을 토대로 국외 3개, 국내 5개 데이터베이스에서 검색하였으며, 문헌 선정과정은 문헌선택 및 배제기준에 따라 2명의 평가자가 독립적으로 수행하고, 의견의 불일치가 있는 경우에는 평가자간 합의를 통해 최종 논문을 결정하였다. 문헌의 비뚤림위험 평가는 무작위배정 비교임상시험(Randomized controlled trial)의 경우 Cochrane의 Risk of Bias (RoB)를 사용하여 평가하였고, 비무작위배정 임상시험(Non-randomized studies)은 Risk of Bias Assessment for Nonrandomized Studies (RoBANS)를 사용하였다. 최종 선택된 문헌을 대상으로 2명의 평가자가 독립적으로 평가를 실시하였으며, 의견이 불일치한 경우 평가자간 합의를 통해 일치된 결과를 도출하였다. 모든 자료는 연구단위로 추출하였다. 본 평가에서 수행한 체계적 문헌고찰 결과는 Grading of Recommendations Assessment, Development and Evaluation (GRADE) 방법을 이용하여 근거 수준을 평가하고, 평가 결과를 토대로 권고등급을 결정하였다.

평가 결과 이식형 결찰사를 이용한 전립선 결찰술의 안전성과 효과성은 총 4개의 연구에 근거하여 평가하였다. 선택된 4개(RCT 연구 2개, 후향적 코호트 연구 2개)의 연구는 TriNetX Analytics Network (이하 TriNetX), Premier Healthcare Database (2000년~2018년)(이하 PHD), Safety and Effectiveness of UroLift: LIFT Pivotal Study (이하 L.I.F.T. Study), UroLift® System Post Market Multi-Center Randomized Study (이하 BPH-6)이며 해당 연구결과를 총 6편의 문헌에서 보고하였다. 사전에 결정한 비교치료법 중 전립선동맥색전술과 비교한 문헌은 없었다.

안전성 PUL과 TURP을 비교한 결과는 1개의 RCT연구와 2개의 후향적 코호트 연구에서 보고하였다. 출혈관련 합병증을 보고한 2개(RCT연구(BPH-6), 후향적 코호트 연구(TriNetX))의 연구 중 1개의 RCT연구에서는 두 군간 차이가 없었고(중증 출혈: PUL군 1건(2.2%), TURP군 2건(6%)), 후향적 코호트 연구에서는 TURP군에 비해 PUL군에서 수혈 환자가 유의하게 많았다(p<0.001). 감염을 보고한 2개(RCT연구(BPH-6), 후향적 코호트 연구(TriNetX))의 연구 중 1개의 RCT연구에서는 두 군간 유의한 차이가 없었고, 후향적 코호트 연구에서는 TURP군에 비해 PUL군에서 감염이 유의하게 적게 발생하였다(p<0.01). 1개의 RCT연구에서 중재 후 1년 시점에서 통증을 보고하였으나, 두 군간 유의한 차이가 없었고, 요폐를 보고한 연구 2개(RCT연구 1개, 후향적 코호트 연구 1개)에서도 두 군간 유의한 차이가 확인되지 않았다. 시술 부작용 및 합병증으로 인한 추가적인 중재의 요구도는 1개의 RCT연구(BPH-6)와 2개의 후향적 코호트 연구(TriNetX, PHD)에서 보고하였다. RCT연구에서는 TURP군에 비해 PUL군에서 더 높은 재시술률을 보고하였지만, 통계적으로 유의하지는 않았으며, 후향적 코호트 연구 1개에서는 합병증으로 인한 재입원이 PUL군에서 TURP군보다 유의하게 많은 것으로 보고하였고(p<0.001), 다른 1개 연구에서는 중재군의 발생이 너무 적어 정확한 수치를 제시하지 않아 중재군과 대조군의 유의한 차이는 확인할 수 없었다. ■ PUL vs HoLEP PUL과 HoLEP을 비교한 결과는 2개(TriNetX, PHD)의 후향적 코호트 연구에서 보고하였다. 후향적 코호트 연구 1개(TriNetX)에서는 HoLEP군에 비해 PUL군에서의 수혈을 받은 환자의 비율이 HoLEP군에 비해 유의하게 많았다(p<0.05). 감염발생은 2개의 연구 모두에서 군 간 차이가 없었다. 시술 부작용 및 합병증으로 인한 추가적인 중재의 요구도는 PUL군에서 HoLEP군보다 유의하게 많았다(p<0.001). ■ PUL vs 거짓치료(Sham) PUL과 거짓치료(sham)를 비교한 연구는 1개의 RCT 연구(LIFT)로 해당 연구에서는 거짓치료군에 비해 PUL군에서 혈뇨발생이 더 많았고(p<0.01), 중증의 합병증인 혈전이 PUL 시술을 받은 140명 중 1명(0.7%)에서 발생한 것으로 보고하였다. 감염은 두 군간 유의한 차이가 없었고, 통증은 PUL군에서 sham군보다 유의하게 많이 발생하였다(p<0.05). 안전성에 대한 근거수준은 PUL과 TURP, PUL과 HoLEP를 비교한 결과는 낮음(Low), PUL과 거짓치료(sham)를 비교한 결과는 높음(High)에서 중등도(Moderate)로 평가되었다.

효과성 PUL의 효과성은 전립선 비대증의 증상개선정도, 요역동학적 효과, 효과부족으로 인한 도뇨관 삽입률 및 도뇨관 삽입기간, 성기능 장애, 효과미흡으로 인한 추가적인 중재의 요구도로 평가하였다. ■ PUL vs TURP PUL과 TURP을 비교한 결과는 1개의 RCT(BPH-6)연구와 2개의 후향적 코호트 연구(TriNetX, PHD)에서 보고하였다. 전립선 비대증의 증상개선정도는 요로증상점수와 삶의 질로 평가하였다. RCT연구 1개에서 TURP군의 요로증상점수가 PUL군보다 낮았고(p<0.001), 삶의 질은 두 군간 유의한 차이가 없다고 보고하였다. 동일한 연구에서 요역동학적 효과를 최대요속과 잔뇨량으로 평가하였는데, 최대요속은 PUL군보다 TURP군에서 유의하게 향상되었고(p<0.01), 잔뇨량은 중재 후 12개월 시점에서 TURP군에서 통계적으로 유의하게 적었으나(p<0.01), 24개월 시점에서는 군간 유의한 차이가 없었다. 또한 발기부전과 사정기능장애로 성기능장애를 평가하였고, 발기부전은 두 군간 유의한 차이가 없었으나 사정기능장애 중 MSHQ-EJD function 점수에서만 TURP군에 비해 PUL군에서 유의한 개선을 보고하였다(p<0.01). 효과부족으로 인한 추가적인 중재의 요구도는 1편의 RCT연구와 2편의 후향적 코호트 연구에서 보고하였다. 1편의 후향적 코호트 연구에서 TURP군에 비해 PUL군에서 유의하게 재입원 빈도가 높은 것으로 보고하였고(p<0.001), 나머지 연구들에서는 두 군간 유의한 차이가 없었다. ■ PUL vs HoLEP PUL과 HoLEP을 비교한 후향적 코호트 연구인 TriNetX에서 HoLEP군에 비해 PUL군에서 재치료가 유의하게 더 많았다고 보고하였다(p<0.001). ■ PUL vs 거짓치료(Sham) PUL과 거짓치료(sham)를 비교한 1개의 RCT연구 LIFT study에서는 전립선 비대증의 증상개선정도를 측정한 증상개선점수(p<0.01)와 삶의 질(p<0.001) 모두 PUL군에서 거짓치료(sham)군에 비해 유의하게 향상되었다고 보고하였다. 또한 PUL군에서 거짓치료(sham)군에 비해 요역동학적 효과가 유의하게 향상되었으며(p<0.01), PUL군에서 효과부족으로 인한 도뇨관 삽입률 및 삽입기간은 평균 0.9일 시점에 32%가 효과가 없어 카테터를 재사용하였다고 보고하였다. 3개월 기준 두 군간 성기능장애는 차이가 없었다고 보고하였다. 효과성에 대한 근거수준은 PUL과 TURP를 비교한 결과는 중등도(Moderate)에서 매우 낮음(Very Low), PUL과 HoLEP를 비교한 결과는 낮음(Low), PUL과 거짓치료(sham)를 비교한 결과는 높음(High)에서 중등도(Moderate)로 평가되었다.

결론 및 제언 해당 소위원회에서는 현재 평가결과에 근거하여 이식형 결찰사를 이용한 전립선 결찰술에 대하여 다음과 같이 제언하였다. 동 시술은 비교시술인 경요도적 전립선 절제술(TURP), 홀뮴 레이저 전립선 적출술(HoLEP)과 유사한 수준의 부작용 및 합병증 발생률을 보고하고 있어 동 시술의 안전성은 임상적으로 수용가능하다고 판단하였다. 또한 거짓치료(Sham)에 비해 유의한 전립선 비대증의 증상개선 및 요역동학적 효과를 확인할 수 있었으나 경요도적 전립선 절제술(TURP) 혹은 홀뮴 레이저전립선 적출술(HoLEP)에 비해서는 효과적이지 않은 것을 판단하였다. 이에 소위원회는 동 시술에 대한 장기 추적결과가 아직 부족한 실정으로 추후 안전성 및 효과성에 대한 추가 근거확인이 필요하지만, 현재까지의 근거를 기준으로 판단할 때, 경요도적 전립선 절제술(TURP)에 필요한 마취에 제한이 있거나 시술 후 발생할 수 있는 성기능 문제의 가능성을 수용할 수 없는 환자에서 동 시술의 적용을 고려해볼 수 있다는 의견이었다. 따라서 소위원회는 이식형 결찰사를 이용한 전립선 결찰술은 전립선 비대증 환자 중 하부요로장애를 가진 환자에서 안전하고, 환자 상태 및 선호에 따라 제한적으로 사용할 수 있는 기술로 평가하였다. 2022년 제5차 의료기술재평가위원회(2022.5.13.)에서는 소위원회 검토 결과에 근거하여 의료기술재평가사업 관리지침 제4조 제10항에 의거 ‘이식형 결찰술을 이용한 전립선 결찰술’에 대해 다음과 같이 심의하였다. 이식형 결찰사를 이용한 전립선 결찰술은 다른 비교시술과 비교하여 유사한 안전성을 가지고 있지만, 비교시술에 비해 효과가 낮고, 장기 추적결과가 아직 부족한 기술로 판단하였다. 그러나 동 기술은 경요도적 전립선 절제술(TURP) 시행을 위한 마취에 제한이 있거나 시술로 인한 성기능 장애의 발생 가능성을 수용할 수 없는 환자에서 제한적 사용을 고려해볼 수 있는 기술로 평가하였다. 이에 의료기술재평가위원회는 이식형 결찰사를 이용한 전립선 결찰술은 비교시술에 비해 효과가 미흡하고 장기 추적 결과가 아직 부족한 기술이나, 하부요료장애를 가진 전립선 비대증 환자 중 다른 시술을 시행할 때 필요한 마취에 제한이 있거나 시술로 인한 발생할 수 있는 성기능장애 가능성을 수용하기 어려운 환자에서만 동 시술의 적용을 고려하여 ‘조건부 권고함’으로 심의하였다.

주요어 전립선 비대증, 하부요로증상, 요로방광경부폐쇄

Background Prostatic Urethral Lift (PUL) using an Implantable Device is a procedure that lifts or holds the enlarged prostate tissue permanently using an implantable device, thereby expanding the urethral lumen to treat urinary tract obstruction for patients with benign prostatic hyperplasia (BPH) who are over 50 years old and have a prostate volume of less than 100cc. The health technology was evaluated as a safe and effective procedure at the 5th New Health Technology Assessment Committee in May 2015, and was listed as a non-reimbursable treatment act in 2016. The technology has been used in clinical practice to date. This health technology was identified through internal monitoring and its adequacy and necessity for reassessment was acknowledged through the process of clinical advisory meeting and priority review for selection of target health technologies for reassessment, and it was finally selected as a technology subject to health technology reassessment (HTR) at the 9th Health Technology Reassessment Committee (September 10, 2021) in 2021. In this assessment, with the aim of supporting policy decision-making such as optimal utilization of Prostatic Urethral Lift using an Implantable Device, we aim to examine and establish medical and scientific evidence for clinical safety and effectiveness of the health technology.

Methods A systematic review of the related literature was conducted for assessment of the safety and effectiveness of Prostatic Urethral Lift using an Implantable Device. All assessment methods were finalized after review by the Prostatic Urethral Lift using an Implantable Device Sub-committee (Hereinafter Sub-committee) in consideration of the purpose of the assessment. The Sub-committee consisted of a total of four experts: three in Urology, and one in Evidence-Based Medicine. The key question was “Is the Prostatic Urethral Lift using an Implantable Device clinically safe and effective for patients with benign prostatic hyperplasia (BPH)?” The technologies for comparison with the target technology for assessment (Prostatic Urethral Lift using an Implantable Device) included transurethral resection of the prostate (TURP), Holmium Laser Enucleation of the Prostate (HoLEP), prostate arterial embolization, and sham procedure. The safety of technology was assessed based on procedure-related adverse events and complications, and the measures included bleeding-related complications, cardiopulmonary complications, infection, pain, urinary retention, as well as urinary catheterization rate and mean duration of catheterization due to adverse events and complications, and needs for additional interventions due to adverse events and complications. The effectiveness of the technology was assessed based on the improvement in BPH symptoms, improvement in urodynamic outcomes, urinary catheterization rate and mean duration of catheterization due to lack of effects, and needs for additional interventions due to lack of effects. In the process of systematic review, based on the key question, three international and five domestic databases were used for literature search and the articles were selected based on independent screening by two assessors according to the inclusion/exclusion criteria for the related literature. In case of disagreement, the two assessors held discussions to draw consensus on the matter for final determination on selection of articles. For risk of bias assessment of the literature, Cochrane’s Risk of Bias (RoB) was used for randomized controlled trials, and the Risk of Bias Assessment for Nonrandomized Studies (RoBANS) tool was used for non-randomized studies. Two assessors performed independent assessment of the finally selected literature, and in case of disagreement, consensus was drawn through discussion between assessors. All data were extracted in units of study. For the results of the systematic review conducted in this assessment, the level of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method, and the Grade of Recommendation was determined based on the assessment results.

Results The safety and effectiveness of Prostatic Urethral Lift using an Implantable Device were evaluated based on a total of 4 studies. The four selected studies (2 randomized controlled trials (RCTs), 2 retrospective cohort studies) were TriNetX Analytics Network (hereinafter TriNetX), Premier Healthcare Database (2000-2018) (hereinafter PHD), Safety and Effectiveness of UroLift: LIFT Pivotal Study (hereinafter L.I.F.T. Study) and UroLift® System Post Market Multi-Center Randomized Study (hereinafter BPH-6), and the results of these studies have been reported in 6 articles in total. Among the pre-determined comparative treatments, there was no article that reported comparison with prostate arterial embolization.

Safety The results of comparing PUL and TURP were reported in one RCT and two retrospective cohort studies. From the two studies (one RCT study (BPH-6) and one retrospective cohort study (TriNetX)) that reported bleeding-related complications, there was no difference between the two groups in the RCT study (Severe bleeding: 1 case in the PUL group (2.2%), 2 cases in the TURP group (6%)), and in the retrospective cohort study, the number of patients that received transfusion was significantly more in the PUL group than in the TURP group (p<0.001). From the two studies that reported on incidence of infection (one RCT study (BPH-6) and one retrospective cohort study (TriNetX)), there was no significant difference between the two groups in the RCT study, and in the retrospective cohort study, significantly fewer incidences of infection were reported in the PUL group than in the TURP group (p<0.01). One RCT study reported incidence of pain at 1 year after intervention, but there was no significant difference between the two groups, and in two studies that reported incidence of urinary retention (one RCT, one retrospective cohort study), no significant difference was confirmed between the two groups. Needs of additional interventions due to procedure-related adverse events and complications were reported in one RCT (BPH-6) and two retrospective cohort studies (TriNetX, PHD). In RCT, higher reoperation rate was reported in the PUL group than in the TURP group, but the difference was not statistically significant, and in one retrospective cohort study, the incidence of readmission due to complications was higher in the PUL group than in the TURP group (p<0.001). In another study, the incidence of the intervention group was too small, and accurate figures were not presented; thus, a significant difference between the intervention group and the control group could not be confirmed in this study.

■ PUL vs HoLEP The results of comparing PUL and HoLEP were reported in two retrospective cohort studies (TriNetX, PHD). In one retrospective cohort study (TriNetX), the proportion of patients receiving blood transfusions was significantly higher in the PUL group than in the HoLEP group (p<0.05). The incidence of infection did not differ between groups in both studies. The need for additional intervention due to procedure-related adverse events and complications was significantly higher in the PUL group than in the HoLEP group (p<0.001).

■ PUL vs sham There was one RCT study (LIFT) that compared PUL with sham treatment. In this study, higher incidence of hematuria was reported in the PUL group than in the sham treatment group (p<0.01). The blood clot in urine, which is classified as serious complications, was reported in one patient (0.7%) out of 140 patients that underwent PUL. There was no significant difference in incidence of infection between the two groups, and pain incidence was significantly higher in the PUL group than in the sham group (p<0.05). The level of evidence for safety was assessed as “Low” for the result of comparing PUL and TURP, PUL and HoLEP, and “High” to “Moderate” for the result of comparing PUL and sham treatment.

Effectiveness The effectiveness of PUL was assessed based on the improvement in symptoms of BPH, improvement in urodynamic outcomes, urinary catheterization rate and mean duration of catheterization due to lack of effect, sexual dysfunction, and the need for additional intervention due to lack of effect.

■ PUL vs TURP The results of comparing PUL and TURP were reported in one RCT (BPH-6) study and two retrospective cohort studies (TriNetX, PHD). The improvement in symptoms of BPH was assessed using the International Prostate Symptom Score(IPSS) and quality of life. In one RCT study, the IPSS of the TURP group was lower than that of the PUL group (p<0.001), and there was no significant difference in quality of life between the two groups. In the same study, improvement in urodynamic outcomes was evaluated based on the peak flow rate and post-void residual (PVR) urine. The peak flow rate was significantly improved in the TURP group than in the PUL group (p<0.01), and the PVR urine was statistically significantly smaller in the TURP group at the time 12 months after the intervention (p<0.01), but there was no significant difference between the two groups at the time point of 24 months after the intervention. In addition, sexual dysfunction was evaluated based on erectile dysfunction and ejaculatory dysfunction. There was no significant difference in erectile dysfunction between the two groups, but only the MSHQ-EJD function score out of the measures of the ejaculatory dysfunction showed a significant improvement in the PUL group than in the TURP group (p<0.01). The need of additional interventions due to lack of effects was reported in one RCT and two retrospective cohort studies. In one retrospective cohort study, the PUL group reported a significantly higher readmission frequency than the TURP group (p<0.001), and there was no significant difference between the two groups in the other studies.

■ PUL vs HoLEP TriNetX, a retrospective cohort study that compared PUL and HoLEP, reported that incidence of retreatment was significantly higher in the PUL group than in the HoLEP group (p<0.001).

■ PUL vs Sham In one RCT study (LIFT study) that compared PUL and sham treatment, it was reported that both the IPSS (p<0.01), which is a measure for symptom improvement of BPH, and quality of life (p<0.001) showed a significant improvement in the PUL group and in the sham treatment group. In addition, urodynamic outcomes showed a significant improvement in the PUL group compared to the sham group (p<0.01). It was also reported that in terms of urinary catheterization rate and mean duration of catheterization, about 32% of the patients in the PUL group reverted back to using a catheter at an average of 0.9 days. The study also reported that here was no difference in sexual dysfunction between the two groups based on the follow-up of three months. As for the level of evidence for effectiveness, the result of comparing PUL and TURP was assessed as from “Moderate to Very Low”, the result of comparing PUL and HoLEP was assessed to be “Low”, and the result of comparing PUL and sham treatment was assessed as from “High” to “Moderate.”

Conclusion and Suggestions The Sub-Committee suggested the following regarding Stereotactic Breast Excisional Biopsy, based on the results of the present assessment The procedure reported a similar level of incidence of adverse events and complications to those of comparative procedures, transurethral resection of the prostate (TURP) and Holmium Laser Enucleation of the Prostate (HoLEP). Thus, it was considered that the safety of the procedure was clinically acceptable. In addition, the result of the review confirmed a significant improvement in symptoms of BPH and improvement in urodynamic outcomes compared to sham treatment, but the procedure was considered not as effective as TURP or HoLEP. Accordingly, the Sub-committee considered that there is still a lack of long-term follow up results for the procedure, and additional examination on the evidence for safety and effectiveness of the procedure is necessary. However, based on the evidence available at present, it was considered that the procedure may be applied for patients who have limitations in undergoing anesthesia required for TURP or who is unable to accept the possibility of sexual dysfunction after the procedure. Therefore, the Sub-committee assessed that Prostatic Urethral Lift using an Implantable Device is a technology that is safe and can be used in limited cases according to the conditions and preference of patients for those with lower urinary tract dysfunction among BPH patients. Based on the results of the review by the Sub-committee, at the 5th Health Technology Reassessment Committee (May 13, 2022) in 2022, the following is the result of the review for “Prostatic Urethral Lift using an Implantable Device” in accordance with Article 4, Paragraph 10 of the Management Guidelines for Health Technology Reassessment Project. It was reviewed that Prostatic Urethral Lift using an Implantable Device has a similar level of safety compared to other comparative procedures, but it is less effective in comparison to the other procedures, and there is still a lack of long-term follow-up results. However, it was assessed that this technology may be considered for application for patients who have limitations in undergoing anesthesia required for TURP or who is unable to accept the possibility of sexual dysfunction after the procedure. Accordingly, the Health Technology Reassessment Committee determined the Grade of Recommendation for the technology as “Conditional Recommendation” considering that Prostatic Urethral Lift using an Implantable Device is not as effective as other comparative procedures and there is a lack of long-term follow-up results, but only applicable to BPH patients with lower urinary tract dysfunction who have limitations in undergoing anesthesia required for other procedure or who is unable to accept the possibility of sexual dysfunction after the procedure.

Keywords: BPH, Lower Urinary Tract Symptoms, Urinary Bladder Neck Obstruction