Energy delivery systems for treatment of benign prostatic hyperplasia: an evidence-based analysis.

OBJECTIVE

The Ontario Health Technology Advisory Committee asked the Medical Advisory Secretariat (MAS) to conduct a health technology assessment on energy delivery systems for the treatment of benign prostatic hyperplasia (BPH).

CLINICAL NEED

TARGET POPULATION AND CONDITION BPH is a noncancerous enlargement of the prostate gland and the most common benign tumour in aging men. (1) It is the most common cause of lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO) and is an important cause of diminished quality of life among aging men. (2) The primary goal in the management of BPH for most patients is a subjective improvement in urinary symptoms and quality of life. Until the 1930s, open prostatectomy, though invasive, was the most effective form of surgical treatment for BPH. Today, the benchmark surgical treatment for BPH is transurethral resection of the prostate (TURP), which produces significant changes of all subjective and objective outcome parameters. Complications after TURP include hemorrhage during or after the procedure, which often necessitates blood transfusion; transurethral resection (TUR) syndrome; urinary incontinence; bladder neck stricture; and sexual dysfunction. A retrospective review of 4,031 TURP procedures performed by one surgeon between 1979 and 2003 showed that the incidence of complications was 2.4% for blood transfusion, 0.3% for TUR syndrome, 1.5% for hemostatic procedures, 2.8% for bladder neck contracture, and 1% for urinary stricture. However, the incidence of blood transfusion and TUR syndrome decreased as the surgeon's skills improved. During the 1990s, a variety of endoscopic techniques using a range of energy sources have been developed as alternative treatments for BPH. These techniques include the use of light amplification by stimulated emission of radiation (laser), radiofrequency, microwave, and ultrasound, to heat prostate tissue and cause coagulation or vaporization. In addition, new electrosurgical techniques that use higher amounts of energy to cut, coagulate, and vaporize prostatic tissue have entered the market as competitors to TURP. The driving force behind these new treatment modalities is the potential of producing good hemostasis, thereby reducing catheterization time and length of hospital stay. Some have the potential to be used in an office environment and performed under local anesthesia. Therefore, these new procedures have the potential to rival TURP if their effectiveness is proven over the long term.

THE TECHNOLOGY BEING REVIEWED

The following energy-based techniques were considered for assessment: transurethral electrovaporization of the prostate (TUVP)transurethral electrovapor resection of the prostate (TUVRP)transurethral electrovaporization of the prostate using bipolar energy (plasmakinetic vaporization of the prostate [PKVP])visual laser ablation of the prostate (VLAP)transurethral ultrasound guided laser incision prostatectomy (TULIP)contact laser vaporization of the prostate (CLV)interstitial laser coagulation (ILC)holmium laser resection of the prostate (HoLRP)holmium laser enucleation of the prostate (HoLEP)holmium laser ablation of the prostate (HoLAP)potassium titanyl phosphate (KTP) lasertransurethral microwave thermotherapy (TUMT)transurethral needle ablation (TUNA) REVIEW STRATEGY: A search of electronic databases (OVID MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library, and the International Agency for Health Technology Assessment [INAHTA] database) was undertaken to identify evidence published from January 1, 2000 to June 21, 2006. The search was limited to English-language articles and human studies. The literature search identified 284 citations, of which 38 randomized controlled trials (RCTs) met the inclusion criteria. Since the application of high-power (80 W) KTP laser (photoselective vaporization of the prostate [PVP]) has been supported in the United States and has resulted in a rapid diffusion of this technology in the absence of any RCTs, the MAS decided that any comparative studies on PVP should be identified and evaluated. Hence, the literature was searched and one prospective cohort study (3) was identified but evaluated separately.

FINDINGS OF LITERATURE REVIEW AND ANALYSIS

Meta-analysis of the results of RCTs shows that monopolar electrovaporization is as clinically effective as TURP for the relief of urinary symptoms caused by BPH (based on 5-year follow-up data). Meta-analysis of the results of RCTs shows that bipolar electrovaporization (PKVP) is clinically as effective as TURP for the relief of urinary symptoms caused by BPH (based on 1-year follow-up data). Two of the three RCTs on VLAP have shown that patients undergoing VLAP had a significantly lesser improvement in urinary symptom scores compared with patients undergoing TURP.RCTs showed that the time to catheter removal was significantly longer in patients undergoing VLAP compared with patients undergoing TURP.Meta-analysis of the rate of reoperation showed that patients undergoing VLAP had a significantly higher rate of reoperation compared with patients undergoing TURP.Meta-analysis showed that patients undergoing CLV had a significantly lesser improvement in urinary symptom scores compared with TURP at 2 years and at 3 or more years of follow-up.Two RCTs with 6-month and 2-year follow-up showed similar improvement in symptom scores for ILC and TURP.Time to catheter removal was significantly longer in patients undergoing ILC compared with patients undergoing TURP.The results of RCTs on HoLEP with 1-year follow-up showed excellent clinical outcomes with regard to the urinary symptom score and peak urinary flow.Meta-analysis showed that at 1-year follow-up, patients undergoing HoLEP had a significantly greater improvement in urinary symptom scores and peak flow rate compared with patients undergoing TURP.Procedural time is significantly longer in HoLEP compared with TURP.The results of one RCT with 4-year follow-up showed that HoLRP and TURP provided equivalent improvement in urinary symptom scores.The results of one RCT with 1-year follow-up showed that patients undergoing KTP had a lesser improvement in urinary symptom scores than did patients undergoing TURP. However, the results were not significant at longer-term follow-up periods.Two RCTs that provided 3-year follow-up data reported that patients undergoing TUMT had a significantly lesser improvement in symptom score compared with patients undergoing TURP.RCTs reported a longer duration of catheterization for TUMT compared with TURP (P values are not reported).The results of a large RCT with 5-year follow-up showed a significantly lesser improvement in symptom scores in patients undergoing TUNA compared with patients undergoing TURP.Meta-analysis of the rate of reoperation showed that patients undergoing TUNA had a significantly higher rate of reoperation compared with patients undergoing TURP.Based on the results of RCTs, TURP is associated with a 0.5% risk of TUR syndrome, while no cases of TUR syndrome have been reported in patients undergoing monopolar or bipolar electrovaporization, laser-based procedures, TUMT, or TUNA.Based on the results of RCTs, the rate of blood transfusion ranges from 0% to 8.3% in patients undergoing TURP. The rate is about 1.7% in monopolar electrovaporization, 1.4% in bipolar electrovaporization, and 0.4% in the VLAP procedure. No patients undergoing CLV, ILC, HoLEP, HoLRP, KTP, TUMT, and TUNA required blood transfusion.The mean length of hospital stay is between 2 and 5 days for patients undergoing TURP, about 3 days for electrovaporization, about 2 to 4 days for Nd:YAG laser procedures, and about 1 to 2 days for holmium laser procedures. TUMT and TUNA can each be performed as a day procedure in an outpatient setting (0.5 and 1 day respectively).Based on a prospective cohort study, PVP is clinically as effective as TURP for the relief of urinary symptoms caused by BPH (based on 6-month follow-up data). Time to catheter removal was significantly shorter in patients undergoing PVP than in those undergoing TURP. Operating room time was significantly longer in PVP than in TURP. PVP has the potential to reduce health care expenses due to shorter hospital stays.

ECONOMIC ANALYSIS

In the three most recent fiscal years (FY) reported, an average of approximately 5,000 TURP procedures per year were performed in Ontario. From FY 2002 to FY 2004, the total number of surgical interventions decreased by approximately 500 procedures. During this time, the increase in costs of drugs to the government was estimated at approximately $10 million (Cdn); however, there was a concurrent decrease in costs due to a decline in the total number of surgical procedures, estimated at approximately $1.9 million (Cdn). From FY 2002 to FY 2004, the increase in costs associated with the increase in utilization of drugs for the treatment of BPH translates into $353 (Cdn) per patient while the cost savings associated with a decrease in the total number of surgical procedures translates into a savings of $3,906 (Cdn) per patient. The following table summarizes the change in the current budget, depending on various estimates of the total percentage of the 5,000 TURP procedures that might be replaced by other energy-based interventions for the treatment of BPH in the future. Executive Summary Table 1:Budget Impact With Various Estimates of the Percentage of TURP Procedures Captured by Energy-based Interventions for the Treatment of BPHTechnologyCost perprocedure, $Budget Impact of 25% diffusion, $MBudget Impact of 50% diffusion, $MBudget Impact of 75% diffusion, $MBudget Impact of 100% diffusion, $MIncremental Budget Impact, $MTURP3,88719.4Bipolar Electrovaporization4,01119.619.719.920.00.6Monopolar Electrovaporization4,13019.720.020.320.61.2TUMT1,52916.513.510.67.6(11.8) TUNA4,80420.621.722.924.04.6PVP1,18416.012.79.35. (ABSTRACT TRUNCATED)