Mattiasson Anders, Wagrell Lennart, Schelin Sonny, Nordling Jorgen, Richthoff Jonas, Magnusson Bo, Schain Moddy, Larson Thayne, Boyle Emmett, Duelund-Jacobsen Jens, Kroyer Kurt, Ageheim Håkan
Department of Urology, Lund University Hospital, Lund, Sweden.
Urology. 2007 Jan;69(1):91-6; discussion 96-7. doi: 10.1016/j.urology.2006.08.1115.
To compare the efficacy and safety of transurethral microwave thermotherapy (TUMT) with ProstaLund Feedback Treatment, using the CoreTherm device, with transurethral resection of the prostate (TURP) 5 years after treatment.
This prospective, randomized, multicenter study was conducted at 10 centers in the United States and Scandinavia. A total of 154 patients with benign prostatic hyperplasia were randomized to TUMT or TURP in a 2:1 ratio. Patients were followed up at 3, 6, 12, 24, 36, 48, and 60 months after treatment. The intermediate results at 12 and 36 months have been previously reported. The treatment outcome at 5 years was evaluated with the International Prostate Symptom Score (IPSS), quality of life question (QOL), peak urinary flow rate (Qmax), postvoid residual urine volume, and prostate volume. The CoreTherm device differs from other microwave devices in that the intraprostatic temperature is constantly measured during the procedure to guide the treatment.
Of the 154 patients, 66% completed the 60 months of follow-up. Statistically significant improvements in the TUMT and TURP groups were observed for IPSS, QOL, and Qmax at 60 months. The average values for the TUMT group were an IPSS of 7.4, QOL score of 1.1, and Qmax of 11.4 mL/s. The values for the TURP group were IPSS of 6.0, QOL score of 1.1, and Qmax of 13.6 mL/s. No statistically significant differences were found in any of these variables between the two treatment groups. In the TUMT group, 10% needed additional treatment versus 4.3% in the TURP group.
The clinical outcome 5 years after TUMT using the CoreTherm device was comparable to the results seen after TURP. The safety of TUMT using the CoreTherm device compared favorably with that of TURP.
比较使用CoreTherm设备的经尿道微波热疗(TUMT)联合前列腺隆德反馈治疗与经尿道前列腺切除术(TURP)治疗5年后的疗效和安全性。
这项前瞻性、随机、多中心研究在美国和斯堪的纳维亚的10个中心进行。总共154例良性前列腺增生患者按2:1的比例随机分为TUMT组或TURP组。在治疗后的3、6、12、24、36、48和60个月对患者进行随访。12个月和36个月时的中期结果此前已报道。使用国际前列腺症状评分(IPSS)、生活质量问题(QOL)、最大尿流率(Qmax)、排尿后残余尿量和前列腺体积评估5年时的治疗结果。CoreTherm设备与其他微波设备的不同之处在于,在手术过程中持续测量前列腺内温度以指导治疗。
154例患者中,66%完成了60个月的随访。在60个月时,TUMT组和TURP组的IPSS、QOL和Qmax均有统计学意义的改善。TUMT组的平均值为IPSS 7.4、QOL评分为1.1、Qmax为11.4 mL/s。TURP组的值为IPSS 6.0、QOL评分为1.1、Qmax为13.6 mL/s。两个治疗组在这些变量中的任何一个均未发现统计学意义的差异。在TUMT组中,10%的患者需要额外治疗,而TURP组为4.3%。
使用CoreTherm设备进行TUMT治疗5年后的临床结果与TURP术后的结果相当。使用CoreTherm设备进行TUMT的安全性优于TURP。