BACKGROUND: 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. METHODS: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.
RCT Entities:
BACKGROUND: 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. METHODS: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.
Authors: Naomi M Gades; Debra J Jacobson; Michaela E McGree; Michael M Lieber; Rosebud O Roberts; Cynthia J Girman; Steven J Jacobsen Journal: BMC Med Res Methodol Date: 2006-12-14 Impact factor: 4.615