Cockett A T, Barry M J, Holtgrewe H L, Sihelnick S, Williams R, McConnell J
University of Rochester, New York.
Cancer. 1992 Jul 1;70(1 Suppl):280-3. doi: 10.1002/1097-0142(19920701)70:1+<280::aid-cncr2820701315>3.0.co;2-e.
In 1990, a pilot study was begun that evaluated benign prostatic hyperplasia (BPH) at five clinical institutions. Data management and coordination of this study was performed at the Medical Practices Evaluation Center at Massachusetts General Hospital. Because of decreased patient enrollment, one institution was dropped. This was a randomized, prospective, clinical study that provided an initial overview of the trial and a rationale for the project.
Patients with clinically significant signs and symptoms of BPH were enrolled in this study. A symptom index consisting of seven items was used to document patient complaints of prostatic enlargement. Prostate size was determined using ultrasonography. Uroflowmetry (peak flow and mean flow) and residual urine volumes were documented. Abdominal ultrasonography was performed to rule out the presence of a dilated upper urinary tract. Cystoscopy was completed to determine the extent of prostatic and bladder neck obstruction. Trabeculations or cellules in the bladder, if present, were also documented. Conclusions. Preliminary results were obtained. The operative and nonoperative options depending on prostate size are shown in the figures of this article. The use of an interactive video disc has been beneficial in explaining the risks and benefits of each treatment option applicable to the patient in this randomized, controlled study.
1990年启动了一项试点研究，在五个临床机构评估良性前列腺增生（BPH）。该研究的数据管理与协调工作在马萨诸塞州总医院的医疗实践评估中心进行。由于患者入组人数减少，一个机构被剔除。这是一项随机、前瞻性临床研究，提供了该试验的初步概况及项目依据。
有临床显著意义的BPH体征和症状的患者纳入本研究。使用包含七个项目的症状指数记录患者关于前列腺增大的主诉。通过超声检查确定前列腺大小。记录尿流率（峰值流速和平均流速）及残余尿量。进行腹部超声检查以排除上尿路扩张的存在。完成膀胱镜检查以确定前列腺和膀胱颈梗阻的程度。如有膀胱小梁或小房也进行记录。结论。获得了初步结果。根据前列腺大小的手术和非手术选择见本文附图。在这项随机对照研究中，使用交互式视频光盘有助于向患者解释每种治疗选择的风险和益处。
