OBJECTIVES: To study the efficacy and safety of a new transurethral microwave thermotherapy device (the Urowave) in the treatment of @entity1 with clinical @entity1067 ( @entity1067 ) in a randomized, double-blind, sham-controlled trial. METHODS: A total of 220 @entity1 (mean age 66.2 years) with clinical @entity1067 , an American Urological Association symptom index (AUA SI) of 13 points or more, and a peak flow rate of 12 mL/s or less were enrolled and randomized 2:1 for active versus sham treatment. All treatments were conducted as an outpatient procedure under local anesthesia, with oral sedation and @entity1337 only. @entity1 were followed up at 1 week and 1, 3, and 6 months after treatment. RESULTS: The treatments were well tolerated, and no @entity1 received general or spinal anesthesia. The AUA SI dropped from 23.6 to 12.7 points at 6 months (P < 0.05) in the active group and from 23.9 to 18.0 points in the sham-treated group (P < 0.05, between-group difference). Statistically significant improvements were also noted for peak flow rate (7.7 to 10.7 mL/s at 6 months for active treatment, 8.1 to 9.8 mL/s for sham treatment, P < 0.05, between-group difference) and for average flow rate. A decrease in AUA SI of more than 30% was achieved in 72% versus 38% of @entity1 (active versus sham treatment, respectively) and more than 50% in 50% versus 19% of @entity1 . In general, active Urowave-treated @entity1 perceived "a lot" of improvement, whereas sham-treated @entity1 perceived "a little" to "some" improvement. More of the actively treated @entity1 had @entity3833 and urgency after treatment, and @entity409 (e.g., @entity13426 ) was more common in actively treated @entity1 as well. Secondary urinary retention after removal of the catheter occurred in 8 @entity1 (5.4%). CONCLUSIONS: The Dornier Urowave transurethral microwave thermotherapy device for treatment of clinical @entity1067 is effective in decreasing symptoms and bother and improving quality of life and flow rate and is superior to sham treatment. @entity1 perceive a great deal of improvement, independent of their baseline symptom severity. Adverse events are in general transient and mild in nature. Extended follow-up is necessary to document long-term durability of improvements.

Microwave thermotherapy for XXXX with the Dornier Urowave: results of a randomized, double-blind, multicenter, sham-controlled trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'men'] @entity13426 :: ('MESH:D051516', 'Disease') :: ['hematospermia'] @entity1067 :: ('MESH:D011470', 'Disease') :: ['benign prostatic hyperplasia', 'BPH'] @entity1337 :: ('MESH:D000699', 'Disease') :: ['analgesia'] @entity409 :: ('MESH:D008107', 'Disease') :: ['ejaculatory dysfunction'] @entity3833 :: ('MESH:D053159', 'Disease') :: ['dysuria']
@entity1067 :: (MESH:D011470,Disease) :: ['benign prostatic hyperplasia']
