title: Results of a 5-year multicenter trial of a new generation cooled high energy transurethral microwave thermal therapy catheter for benign prostatic hyperplasia.
abstract: OBJECTIVE
  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 men with lower urinary tract symptoms and clinical benign prostatic hyperplasia.
  
  
  METHODS
  At 5 American centers a total of 66 men were treated with the catheter at a 28.5-minute session. Patients 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, Benign Prostatic Hyperplasia Impact Index, treatment satisfaction, adverse events and need for re-treatment.
  
  
  RESULTS
  Average treatment duration was 29 minutes. Of the 66 men 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 men (29%) underwent additional medical or surgical benign prostatic hyperplasia related treatment at some time during the 5-year followup. Six men (9%) underwent surgical benign prostatic hyperplasia related treatment. At 5 years 40 of 51 men (78%) reported satisfaction with benign prostatic hyperplasia treatment.
  
  
  CONCLUSIONS
  Cooled, high energy transurethral microwave thermal therapy using a new generation treatment catheter produced safe, durable, clinically relevant results in men with lower urinary tract symptoms caused by benign prostatic hyperplasia for 5 years after treatment with acceptable medical and surgical re-treatment rates.
authors.affiliation: Department of Urology, Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Lance A
authors.initials: LA
authors.lastname: Mynderse
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.forename: Alan W
authors.initials: AW
authors.lastname: Partin
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Preminger
authors.forename: Eric P
authors.initials: EP
authors.lastname: Coté
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003972:Diathermy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008872:Microwaves / Q000627:therapeutic use*; D008875:Middle Aged; D017060:Patient Satisfaction; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000628:therapy*; D011788:Quality of Life; D019233:Retreatment; D016896:Treatment Outcome; D014481:United States; D014563:Urodynamics