Convective Thermal Therapy: Durable 2-Year Results of Randomized Controlled and Prospective Crossover Studies for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Claus Roehrborn, Steven N. Gange, Marc C. Gittelman, Kenneth Allen Goldberg, Kalpesh Patel, Neal D. Shore, Richard M. Levin, Michael Rousseau, J. Randolf Beahrs, Jed Kaminetsky, Barrett E. Cowan, Christopher H. Cantrill, Lance A. Mynderse, James C. Ulchaker, Thayne R. Larson, Christopher M. Dixon, Kevin T. McVary

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Purpose We report 2-year outcomes of a multicenter randomized controlled trial plus 1-year results of a crossover trial after treatment with convective radiofrequency water vapor thermal energy for lower urinary tract symptoms due to benign prostatic hyperplasia. Materials and Methods A total of 197 men at least 50 years old with I-PSS (International Prostate Symptom Score) 13 or greater, maximum flow rate 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 to thermal therapy with the Rezūm® System or a control group. Rigid cystoscopy with simulated active treatment sounds served as the control procedure. After unblinding at 3 months control subjects could requalify for crossover study. Convectively delivered radiofrequency thermal energy was delivered into obstructive prostate tissue, including the median lobe as needed. The primary efficacy end point was a change in severity of symptom scores. Results Convective radiofrequency thermal therapy improved urinary symptoms significantly over controls at 3 months and provided a sustained 51% reduction from baseline at 24 months (p <0.0001). This produced a 5 and 8-point or greater score decrease in 84% and 74% of subjects, respectively, at 24 months. Crossover subject symptoms, flow rate and quality of life measures were markedly improved after thermal therapy compared to after the control procedure (p = 0.024 to <0.0001). No de novo erectile dysfunction was reported. Conclusions Convective radiofrequency water vapor thermal therapy is a minimally invasive office or outpatient procedure that provides early effective symptom relief that remains durable for 2 years and is applicable to the median lobe.

Original languageEnglish (US)
Pages (from-to)1507-1516
Number of pages10
JournalJournal of Urology
Volume197
Issue number6
DOIs
StatePublished - Jun 1 2017

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Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Cross-Over Studies
Hot Temperature
Prospective Studies
Prostate
Steam
Therapeutics
Cystoscopy
Erectile Dysfunction
Outpatients
Randomized Controlled Trials
Quality of Life
Control Groups

Keywords

  • convection
  • lower urinary tract symptoms
  • prostate
  • prostatic hyperplasia

ASJC Scopus subject areas

  • Urology

Cite this

Convective Thermal Therapy : Durable 2-Year Results of Randomized Controlled and Prospective Crossover Studies for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. / Roehrborn, Claus; Gange, Steven N.; Gittelman, Marc C.; Goldberg, Kenneth Allen; Patel, Kalpesh; Shore, Neal D.; Levin, Richard M.; Rousseau, Michael; Beahrs, J. Randolf; Kaminetsky, Jed; Cowan, Barrett E.; Cantrill, Christopher H.; Mynderse, Lance A.; Ulchaker, James C.; Larson, Thayne R.; Dixon, Christopher M.; McVary, Kevin T.

In: Journal of Urology, Vol. 197, No. 6, 01.06.2017, p. 1507-1516.

Research output: Contribution to journalArticle

Roehrborn, C, Gange, SN, Gittelman, MC, Goldberg, KA, Patel, K, Shore, ND, Levin, RM, Rousseau, M, Beahrs, JR, Kaminetsky, J, Cowan, BE, Cantrill, CH, Mynderse, LA, Ulchaker, JC, Larson, TR, Dixon, CM & McVary, KT 2017, 'Convective Thermal Therapy: Durable 2-Year Results of Randomized Controlled and Prospective Crossover Studies for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia', Journal of Urology, vol. 197, no. 6, pp. 1507-1516. https://doi.org/10.1016/j.juro.2016.12.045
Roehrborn, Claus ; Gange, Steven N. ; Gittelman, Marc C. ; Goldberg, Kenneth Allen ; Patel, Kalpesh ; Shore, Neal D. ; Levin, Richard M. ; Rousseau, Michael ; Beahrs, J. Randolf ; Kaminetsky, Jed ; Cowan, Barrett E. ; Cantrill, Christopher H. ; Mynderse, Lance A. ; Ulchaker, James C. ; Larson, Thayne R. ; Dixon, Christopher M. ; McVary, Kevin T. / Convective Thermal Therapy : Durable 2-Year Results of Randomized Controlled and Prospective Crossover Studies for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. In: Journal of Urology. 2017 ; Vol. 197, No. 6. pp. 1507-1516.
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abstract = "Purpose We report 2-year outcomes of a multicenter randomized controlled trial plus 1-year results of a crossover trial after treatment with convective radiofrequency water vapor thermal energy for lower urinary tract symptoms due to benign prostatic hyperplasia. Materials and Methods A total of 197 men at least 50 years old with I-PSS (International Prostate Symptom Score) 13 or greater, maximum flow rate 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 to thermal therapy with the Rezūm{\circledR} System or a control group. Rigid cystoscopy with simulated active treatment sounds served as the control procedure. After unblinding at 3 months control subjects could requalify for crossover study. Convectively delivered radiofrequency thermal energy was delivered into obstructive prostate tissue, including the median lobe as needed. The primary efficacy end point was a change in severity of symptom scores. Results Convective radiofrequency thermal therapy improved urinary symptoms significantly over controls at 3 months and provided a sustained 51{\%} reduction from baseline at 24 months (p <0.0001). This produced a 5 and 8-point or greater score decrease in 84{\%} and 74{\%} of subjects, respectively, at 24 months. Crossover subject symptoms, flow rate and quality of life measures were markedly improved after thermal therapy compared to after the control procedure (p = 0.024 to <0.0001). No de novo erectile dysfunction was reported. Conclusions Convective radiofrequency water vapor thermal therapy is a minimally invasive office or outpatient procedure that provides early effective symptom relief that remains durable for 2 years and is applicable to the median lobe.",
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AU - Dixon, Christopher M.

AU - McVary, Kevin T.

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N2 - Purpose We report 2-year outcomes of a multicenter randomized controlled trial plus 1-year results of a crossover trial after treatment with convective radiofrequency water vapor thermal energy for lower urinary tract symptoms due to benign prostatic hyperplasia. Materials and Methods A total of 197 men at least 50 years old with I-PSS (International Prostate Symptom Score) 13 or greater, maximum flow rate 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 to thermal therapy with the Rezūm® System or a control group. Rigid cystoscopy with simulated active treatment sounds served as the control procedure. After unblinding at 3 months control subjects could requalify for crossover study. Convectively delivered radiofrequency thermal energy was delivered into obstructive prostate tissue, including the median lobe as needed. The primary efficacy end point was a change in severity of symptom scores. Results Convective radiofrequency thermal therapy improved urinary symptoms significantly over controls at 3 months and provided a sustained 51% reduction from baseline at 24 months (p <0.0001). This produced a 5 and 8-point or greater score decrease in 84% and 74% of subjects, respectively, at 24 months. Crossover subject symptoms, flow rate and quality of life measures were markedly improved after thermal therapy compared to after the control procedure (p = 0.024 to <0.0001). No de novo erectile dysfunction was reported. Conclusions Convective radiofrequency water vapor thermal therapy is a minimally invasive office or outpatient procedure that provides early effective symptom relief that remains durable for 2 years and is applicable to the median lobe.

AB - Purpose We report 2-year outcomes of a multicenter randomized controlled trial plus 1-year results of a crossover trial after treatment with convective radiofrequency water vapor thermal energy for lower urinary tract symptoms due to benign prostatic hyperplasia. Materials and Methods A total of 197 men at least 50 years old with I-PSS (International Prostate Symptom Score) 13 or greater, maximum flow rate 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 to thermal therapy with the Rezūm® System or a control group. Rigid cystoscopy with simulated active treatment sounds served as the control procedure. After unblinding at 3 months control subjects could requalify for crossover study. Convectively delivered radiofrequency thermal energy was delivered into obstructive prostate tissue, including the median lobe as needed. The primary efficacy end point was a change in severity of symptom scores. Results Convective radiofrequency thermal therapy improved urinary symptoms significantly over controls at 3 months and provided a sustained 51% reduction from baseline at 24 months (p <0.0001). This produced a 5 and 8-point or greater score decrease in 84% and 74% of subjects, respectively, at 24 months. Crossover subject symptoms, flow rate and quality of life measures were markedly improved after thermal therapy compared to after the control procedure (p = 0.024 to <0.0001). No de novo erectile dysfunction was reported. Conclusions Convective radiofrequency water vapor thermal therapy is a minimally invasive office or outpatient procedure that provides early effective symptom relief that remains durable for 2 years and is applicable to the median lobe.

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KW - prostatic hyperplasia

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