Results of a 5-year Multicenter Trial of a New Generation Cooled High Energy Transurethral Microwave Thermal Therapy Catheter for Benign Prostatic Hyperplasia

J Urol. 2011 May;185(5):1804-10. doi: 10.1016/j.juro.2010.12.054. Epub 2011 Mar 21.

Abstract

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 men with lower urinary tract symptoms and clinical benign prostatic hyperplasia.

Materials and 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.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Diathermy / adverse effects
  • Diathermy / instrumentation
  • Diathermy / methods*
  • Humans
  • Magnetic Resonance Imaging
  • Male
  • Microwaves / therapeutic use*
  • Middle Aged
  • Patient Satisfaction
  • Proportional Hazards Models
  • Prospective Studies
  • Prostatic Hyperplasia / therapy*
  • Quality of Life
  • Retreatment
  • Treatment Outcome
  • United States
  • Urodynamics