BACKGROUND:Transurethral resection of the prostate is the most common surgical treatment for benign prostatic hyperplasia. We conducted a multicenter randomized trial to compare this surgery with watchful waiting in men with moderate symptoms of benign prostatic hyperplasia. METHODS: Of 800 men over the age of 54 years who were screened between July 1986 and July 1989, 556 (mean [+/- SD] age, 66 +/- 5 years) were studied (280 in the surgery group and 276 in the watchful-waiting group). Patients' symptoms and the degree to which they were bothered by urinary difficulties were measured with standardized questionnaires and medical evaluations. The primary outcome measure was treatment failure, which was defined as the occurrence of any of the following: death, repeated or intractable urinary retention, a residual urinary volume over 350 ml, the development of bladder calculus, new and persistent incontinence, a high symptom score, or a doubling of the serum creatinine concentration. Patients were followed for three years. RESULTS: Of the men randomly assigned to the surgery group, 249 underwent surgery within two weeks after the assignment. Surgery was not associated with impotence or urinary incontinence. The average follow-up period was 2.8 years. In an intention-to-treat analysis, there were 23 treatment failures in the surgery group, as compared with 47 in the watchful-waiting group (relative risk, 0.48; 95 percent confidence interval, 0.30 to 0.77). Of the men assigned to the watchful-waiting group, 65 (24 percent) underwent surgery within three years after the assignment. Surgery was associated with improvement in symptoms and in scores for urinary difficulties and interference with activities of daily living (P < 0.001 for all comparisons). The outcomes of surgery were best for the men who were most bothered by urinary symptoms at base line. CONCLUSIONS: For men with moderate symptoms of benign prostatic hyperplasia, surgery is more effective than watchful waiting in reducing the rate of treatment failure and improving genitourinary symptoms. Watchful waiting is usually a safe alternative for men who are less bothered by urinary difficulty or who wish to delay surgery.
RCT Entities:
BACKGROUND: Transurethral resection of the prostate is the most common surgical treatment for benign prostatic hyperplasia. We conducted a multicenter randomized trial to compare this surgery with watchful waiting in men with moderate symptoms of benign prostatic hyperplasia. METHODS: Of 800 men over the age of 54 years who were screened between July 1986 and July 1989, 556 (mean [+/- SD] age, 66 +/- 5 years) were studied (280 in the surgery group and 276 in the watchful-waiting group). Patients' symptoms and the degree to which they were bothered by urinary difficulties were measured with standardized questionnaires and medical evaluations. The primary outcome measure was treatment failure, which was defined as the occurrence of any of the following: death, repeated or intractable urinary retention, a residual urinary volume over 350 ml, the development of bladder calculus, new and persistent incontinence, a high symptom score, or a doubling of the serum creatinine concentration. Patients were followed for three years. RESULTS: Of the men randomly assigned to the surgery group, 249 underwent surgery within two weeks after the assignment. Surgery was not associated with impotence or urinary incontinence. The average follow-up period was 2.8 years. In an intention-to-treat analysis, there were 23 treatment failures in the surgery group, as compared with 47 in the watchful-waiting group (relative risk, 0.48; 95 percent confidence interval, 0.30 to 0.77). Of the men assigned to the watchful-waiting group, 65 (24 percent) underwent surgery within three years after the assignment. Surgery was associated with improvement in symptoms and in scores for urinary difficulties and interference with activities of daily living (P < 0.001 for all comparisons). The outcomes of surgery were best for the men who were most bothered by urinary symptoms at base line. CONCLUSIONS: For men with moderate symptoms of benign prostatic hyperplasia, surgery is more effective than watchful waiting in reducing the rate of treatment failure and improving genitourinary symptoms. Watchful waiting is usually a safe alternative for men who are less bothered by urinary difficulty or who wish to delay surgery.
Authors: Christian T Brown; Tet Yap; David A Cromwell; Lorna Rixon; Liz Steed; Kathleen Mulligan; Anthony Mundy; Stanton P Newman; Jan van der Meulen; Mark Emberton Journal: BMJ Date: 2006-11-21