TY - JOUR
T1 - Results of a 5-year multicenter trial of a new generation cooled high energy transurethral microwave thermal therapy catheter for benign prostatic hyperplasia
AU - Mynderse, Lance A.
AU - Roehrborn, Claus
AU - Partin, Alan W.
AU - Preminger, Glenn M.
AU - Coté, Eric P.
PY - 2011/5
Y1 - 2011/5
N2 - 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.
AB - 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.
KW - catheterization
KW - hyperthermia, induced
KW - microwaves
KW - prostate
KW - prostatic hyperplasia
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U2 - 10.1016/j.juro.2010.12.054
DO - 10.1016/j.juro.2010.12.054
M3 - Article
C2 - 21420115
AN - SCOPUS:79953788658
SN - 0022-5347
VL - 185
SP - 1804
EP - 1810
JO - Journal of Urology
JF - Journal of Urology
IS - 5
ER -