A 12‐month study of the placebo effect in transurethral microwave thermotherapy

Abstract

Objective To determine the placebo effect of trans-groups; 62% and 18% of patients had a >50% improvement in symptom score in the treated and urethral microwave thermotherapy (TUMT) in the treatment of benign prostatic enlargement (BPE).sham groups, respectively (P=0.001). The corresponding changes in flow rate were 36% and 11% Patients and methods A prospective, randomized shamcontrolled study in 93 patients (mean age 65, range (P=0.002), respectively. After 1 year, 63 patients were divided into those that had TUMT initally, those 50-88) was conducted at two centres comparing TUMT or a sham treatment. Patients randomized to that had sham initially but subsequently had TUMT and those whose sham procedure had led to sufficient receive sham treatment underwent the same initial procedure as for TUMT, but the complete procedure clinical improvement to require no further treatment. The two treated groups had a significant improvement was simulated on the visual display with no application of microwave energy. If the patient's condition over the sham group. Conclusion The benefit from TUMT cannot be due to a had not improved after 3 months, a second genuine TUMT treatment was given at the patient's request.placebo effect alone. Keywords Benign prostatic enlargement, placebo, Results After 3 months there were significant clinical and statistical differences in efficacy between the thermotherapy (TUMT) was probably ineffective in the treatment of BPE and Patients and methodsFrom June 1991 to December 1992, 93 men (mean age 65 years, range 50-88) were recruited into the study.

Systematic review and economic modelling of effectiveness and cost utility of surgical treatments for men with benign prostatic enlargement

“…125,126,133,159,160,170,172,173 Six of those reported IPSS/AUA scores. 125,126,159,160,170,173 In all studies, IPSS/AUA scores were superior in the TUMT group and this was statistically significant in all six studies (p < 0.05).…”

“…A total of 1209 participants were randomised across 11 eligible RCTs reported in 21 papers. 125,126,133,143,159,160,[170][171][172][173][174][219][220][221][222][223][224][225][226][227][228] Three studies took place in the US, 126,159,170 Although all 11 studies gave some details of the ages of participants, three gave only the mean or median age of the participant group as a whole, regardless of which intervention to which they were randomised. 160,171,174 Of the studies reporting IPSS/AUA scores at entry, 475 (74%) participants allocated to TUMT had severe symptoms of BPE and 60 (9%) had moderate symptoms.…”

“…125,126,133,143,159,160,[170][171][172][173][174] Only peak urine flow rate is presented in this section. Results for the other urodynamic outcomes are presented in Appendix 8.2, Table 50 and Appendix 9.2, comparisons 02:04-02:09.A total of seven studies 125,126,133,159,[172][173][174] reported peak urine flow rate at 3 months after surgery. In all but one study 174 the peak urine flow rate was higher in the TUMT group.…”

Transurethral interstitial laser coagulation of the prostate and transurethral microwave thermotherapy vs transurethral resection or incision of the prostate: results of a randomized, controlled study in patients with symptomatic benign prostatic hyperplasia

“…Several studies using the older software (Prostasoft v2.0) reported acceptable symptomatic effect, better than sham treatment [12], and comparable with TURP [13]. However, with this software the ability of TUMT to reduce infravesical obstruction is clearly limited, and some studies have shown limited durability of the symptomatic response in a high proportion of patients, as re-treatment rates within 2-3 years of 43-48% have been reported [14,15].…”

Elevation of sensory thresholds in the prostatic urethra after microwave thermotherapy

“…The criteria for a successful treatment outcome as recommended by the US Food and Drug Administration indicate that there should be an adequate proportional change as well as in absolute values overall. To allow the results of different studies to be compared, de Wildt et al [19] suggested that a 50% improvement should be the criterion for a successful treatment outcome of TUMT. Nevertheless, in a previous study where we compared 30 or 60 min of TUMT to sham treatment, the improvement was o30% for storage symptoms and was closely related to what the patients perceived as a successful outcome [3].…”