Results of a 5-year multicenter trial of a new generation cooled high energy transurethral microwave thermal therapy catheter for XXXX .

@entity1 @entity1067
PURPOSE: We determined the safety, effectiveness and 5-year durability of the new generation, cooled, high energy microwave treatment Cooled ThermoCath   catheter with the Targis   cooled high energy transurethral microwave thermal therapy system by performing a prospective, multicenter trial in @entity1 with lower urinary tract symptoms and clinical @entity1067 . MATERIALS AND METHODS: At 5 American centers a total of 66 @entity1 were treated with the catheter at a 28.5-minute session. @entity1 were taught self-catheterization after treatment. They returned after 1 and 6 weeks, 3 and 6 months, and annually for 5 years to assess the American Urological Association symptom score, uroflowmetry, quality of life, Symptom Problem Index, @entity1067 Impact Index, treatment satisfaction, adverse events and need for re-treatment. RESULTS: Average treatment duration was 29 minutes. Of the 66 @entity1 33 (50%) required no posttreatment catheterization of any kind, 25 (38%) used intermittent self-catheterization and 8 (12%) required indwelling catheterization with or without self-catheterization. No acute retention events were reported after the initial catheterization through 5 years. No serious adverse events were associated with treatment. Traditional efficacy measures showed highly significant improvement from 6 weeks and thereafter (p <0.001). A total of 19 @entity1 (29%) underwent additional medical or surgical @entity1067 related treatment at some time during the 5-year followup. Six @entity1 (9%) underwent surgical @entity1067 related treatment. At 5 years 40 of 51 @entity1 (78%) reported satisfaction with @entity1067 treatment. CONCLUSIONS: Cooled, high energy transurethral microwave thermal therapy using a new generation treatment catheter produced safe, durable, clinically relevant results in @entity1 with lower urinary tract symptoms caused by @entity1067 for 5 years after treatment with acceptable medical and surgical re-treatment rates.
