Shore Neal D, Dineen Martin K, Saslawsky Mark J, Lumerman Jeffrey H, Corica Alberto P
Grand Strand Urology, Myrtle Beach, South Carolina 29572, USA.
J Urol. 2007 Mar;177(3):1040-6. doi: 10.1016/j.juro.2006.10.059.
The Spanner, a novel prostatic stent, was evaluated for safety, efficacy and patient tolerance when used to relieve prostatic obstruction following transurethral microwave thermotherapy.
Following transurethral microwave thermotherapy and routine post-procedure Foley catheterization at 1 of 9 clinical sites 186 patients meeting study criteria were randomized to receive a Spanner (100) or the standard of care (86). Baseline evaluations included post-void residual urine, uroflowmetry, International Prostate Symptom Score and International Prostate Symptom Score quality of life question. These evaluations were repeated at visits 1, 2, 4, 5 and 8 weeks after randomization (Spanner insertion) with the addition of the Spanner satisfaction questionnaire, ease of use assessment and adverse events recording. The Spanner was removed after 4 weeks, at which time the Spanner and standard of care groups underwent cystourethroscopy.
At the 1 and 2-week visits the Spanner group showed significantly greater improvements from baseline in post-void residual urine, uroflowmetry and International Prostate Symptom Score compared to the standard of care group. The Spanner group experienced significantly greater improvements in quality of life at the 5 and 8-week visits. Patient satisfaction with the Spanner exceeded 86%. Cystourethroscopy findings in the Spanner and standard of care groups were comparable and adverse events associated with previous stents were rare.
The Spanner is a safe, effective and well tolerated temporary stent for severe prostatic obstruction resulting from therapy induced edema after transurethral microwave thermotherapy. It may be a needed addition to the armamentarium for managing bladder outlet obstruction in a broad group of urological patients.
评估一种新型前列腺支架Spanner在经尿道微波热疗后用于缓解前列腺梗阻时的安全性、有效性及患者耐受性。
在9个临床地点之一，对186例符合研究标准的患者进行经尿道微波热疗及术后常规留置Foley导尿管后，随机分为两组，分别接受Spanner（100例）或标准治疗（86例）。基线评估包括排尿后残余尿量、尿流率、国际前列腺症状评分及国际前列腺症状评分生活质量问题。随机分组（插入Spanner）后1、2、4、5和8周复诊时重复上述评估，并增加Spanner满意度问卷、易用性评估及不良事件记录。4周后取出Spanner，此时Spanner组和标准治疗组均接受膀胱尿道镜检查。
在1周和2周复诊时，与标准治疗组相比，Spanner组在排尿后残余尿量、尿流率及国际前列腺症状评分方面较基线有显著更大改善。Spanner组在5周和8周复诊时生活质量有显著更大改善。患者对Spanner的满意度超过86%。Spanner组和标准治疗组的膀胱尿道镜检查结果相当，与既往支架相关的不良事件罕见。
Spanner是一种安全、有效且耐受性良好的临时支架，用于治疗经尿道微波热疗后因治疗引起的水肿导致的严重前列腺梗阻。它可能是广大泌尿外科患者管理膀胱出口梗阻所需的器械补充。
