PURPOSE: To study the long-term outcomes of men with moderately severe symptomatic benign prostatic hyperplasia (BPH) who were treated with transurethral microwave thermotherapy (TUMT) with the Dornier Urowave machine. PATIENTS AND METHODS: A total of 220 patients (mean age 66.2 years) with clinical BPH, an American Urological Association (AUA) Symptom Score of >or=13, and a peak urinary flow rate (Qmax) of <or=12 mL/sec were enrolled in a multicenter randomized, double-blind, sham-controlled trial. Sham and active treatments were conducted under local anesthesia as an outpatient procedure. Patients were followed up at 1 week and at 1, 3, and 6 months. Patients in the sham-treatment arm who still met the initial enrollment criteria were then offered active treatment. The 6-month interim analysis of the safety and efficacy of this treatment has been previously reported (Urology 1998;51:19). Patients were then followed at 6-month intervals out to 60 months after treatment. At our center, 34 men (mean age 64+/-6 years) continued on the recommended long-term follow-up protocol. RESULTS: Among the 34 men from our center initially entered in the study, 15 completed the entire 5-year follow-up. Four of the men available for follow-up at the 5-year mark were on alpha-blocker medication, and six men had required transurethral surgery for symptom relief. At 5 years, this cohort of patients maintained improvement in AUA Score (from 20.5+/-6.2 to 11.5+/-5.0; P<0.001) and Quality of Life score (from 3.7+/-1.3 to 1.9+/-1.0; P<0.001) but showed no significant improvement in Qmax (8.2+/-1.9 mL/sec to 8.4+/-4.3 mL/sec). At 5 years, 11 of the 15 patients available for review had not required additional therapy. CONCLUSIONS: While improvement in voiding symptoms and Quality of Life scores were maintained without the need for adjuvant treatment in approximately one third of men 5 years after TUMT, a significant number had required salvage therapies for symptom relief.
RCT Entities:
PURPOSE: To study the long-term outcomes of men with moderately severe symptomatic benign prostatic hyperplasia (BPH) who were treated with transurethral microwave thermotherapy (TUMT) with the Dornier Urowave machine. PATIENTS AND METHODS: A total of 220 patients (mean age 66.2 years) with clinical BPH, an American Urological Association (AUA) Symptom Score of >or=13, and a peak urinary flow rate (Qmax) of <or=12 mL/sec were enrolled in a multicenter randomized, double-blind, sham-controlled trial. Sham and active treatments were conducted under local anesthesia as an outpatient procedure. Patients were followed up at 1 week and at 1, 3, and 6 months. Patients in the sham-treatment arm who still met the initial enrollment criteria were then offered active treatment. The 6-month interim analysis of the safety and efficacy of this treatment has been previously reported (Urology 1998;51:19). Patients were then followed at 6-month intervals out to 60 months after treatment. At our center, 34 men (mean age 64+/-6 years) continued on the recommended long-term follow-up protocol. RESULTS: Among the 34 men from our center initially entered in the study, 15 completed the entire 5-year follow-up. Four of the men available for follow-up at the 5-year mark were on alpha-blocker medication, and six men had required transurethral surgery for symptom relief. At 5 years, this cohort of patients maintained improvement in AUA Score (from 20.5+/-6.2 to 11.5+/-5.0; P<0.001) and Quality of Life score (from 3.7+/-1.3 to 1.9+/-1.0; P<0.001) but showed no significant improvement in Qmax (8.2+/-1.9 mL/sec to 8.4+/-4.3 mL/sec). At 5 years, 11 of the 15 patients available for review had not required additional therapy. CONCLUSIONS: While improvement in voiding symptoms and Quality of Life scores were maintained without the need for adjuvant treatment in approximately one third of men 5 years after TUMT, a significant number had required salvage therapies for symptom relief.
Authors: Juan Va Franco; Luis Garegnani; Camila Micaela Escobar Liquitay; Michael Borofsky; Philipp Dahm Journal: Cochrane Database Syst Rev Date: 2021-06-28