Erectile and ejaculatory function preserved with convective water vapor energy treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: Randomized controlled study

Kevin T. McVary, 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, Claus Roehrborn

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

Introduction: Most surgical treatments for male lower urinary tract symptoms and benign prostatic hyperplasia affect erectile and ejaculatory functions negatively, leading to patient dissatisfaction. Aim: To determine whether water vapor thermal therapy, when conducted in a randomized controlled trial, would significantly improve lower urinary tract symptoms secondary to benign prostatic hyperplasia and urinary flow rate while preserving erectile and ejaculatory functions. Methods: Men at least 50 years old with International Prostate Symptom Scores of at least 13, a peak flow rate of at least 5 to no higher than 15 mL/s, and prostate volume of 30 to 80 cm3 were randomized 2:1 between Rezūm System thermal therapy and control. Thermal water vapor (103°C) was injected into lateral and median lobes as required for treatment of benign prostatic hyperplasia. The control procedure entailed rigid cystoscopy with simulated active treatment sounds. Main Outcome Measures: Blinded group (active = 136, control = 61) comparison occurred at 3 months and the active arm was followed to 12 months for International Prostate Symptom Score, peak flow rate, and sexual function using the International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function. The minimal clinically important difference in erectile function perceived by subjects as beneficial was determined for each erectile function severity category. Subjects not sexually active were censored from sexual function analysis. Results: No treatment- or device-related de novo erectile dysfunction occurred after thermal therapy. International Index of Erectile Function and Male Sexual Health Questionnaire for Ejaculatory Function scores were not different from the control group at 3 months or from baseline at 1 year. Ejaculatory bother score improved 31% over baseline (P = .0011). Also, 32% of subjects achieved minimal clinically important differences in erectile function scores at 3 months, and 27% at 1 year, including those with moderate to severe erectile dysfunction. International Prostate Symptom Score and peak flow rate were significantly superior to controls at 3 months and throughout 1 year (P <.0001). Conclusion: Convective water vapor thermal therapy provides sustainable improvements for 12 months to lower urinary tract symptoms and urinary flow while preserving erectile and ejaculatory functions.

Original languageEnglish (US)
Pages (from-to)924-933
Number of pages10
JournalJournal of Sexual Medicine
Volume13
Issue number6
DOIs
StatePublished - Jun 1 2016

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Lower Urinary Tract Symptoms
Steam
Prostatic Hyperplasia
Hot Temperature
Prostate
Reproductive Health
Erectile Dysfunction
Therapeutics
Cystoscopy
Randomized Controlled Trials
Outcome Assessment (Health Care)
Equipment and Supplies
Control Groups

Keywords

  • Benign Prostatic Hyperplasia
  • Ejaculatory Dysfunction
  • Erectile Dysfunction
  • Lower Urinary Tract Symptoms
  • Sexual Function
  • Thermal Therapy

ASJC Scopus subject areas

  • Urology
  • Obstetrics and Gynecology
  • Reproductive Medicine

Cite this

Erectile and ejaculatory function preserved with convective water vapor energy treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia : Randomized controlled study. / McVary, Kevin T.; 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.; Roehrborn, Claus.

In: Journal of Sexual Medicine, Vol. 13, No. 6, 01.06.2016, p. 924-933.

Research output: Contribution to journalArticle

McVary, KT, 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 & Roehrborn, C 2016, 'Erectile and ejaculatory function preserved with convective water vapor energy treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: Randomized controlled study', Journal of Sexual Medicine, vol. 13, no. 6, pp. 924-933. https://doi.org/10.1016/j.jsxm.2016.03.372
McVary, Kevin T. ; 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. ; Roehrborn, Claus. / Erectile and ejaculatory function preserved with convective water vapor energy treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia : Randomized controlled study. In: Journal of Sexual Medicine. 2016 ; Vol. 13, No. 6. pp. 924-933.
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abstract = "Introduction: Most surgical treatments for male lower urinary tract symptoms and benign prostatic hyperplasia affect erectile and ejaculatory functions negatively, leading to patient dissatisfaction. Aim: To determine whether water vapor thermal therapy, when conducted in a randomized controlled trial, would significantly improve lower urinary tract symptoms secondary to benign prostatic hyperplasia and urinary flow rate while preserving erectile and ejaculatory functions. Methods: Men at least 50 years old with International Prostate Symptom Scores of at least 13, a peak flow rate of at least 5 to no higher than 15 mL/s, and prostate volume of 30 to 80 cm3 were randomized 2:1 between Rezūm System thermal therapy and control. Thermal water vapor (103°C) was injected into lateral and median lobes as required for treatment of benign prostatic hyperplasia. The control procedure entailed rigid cystoscopy with simulated active treatment sounds. Main Outcome Measures: Blinded group (active = 136, control = 61) comparison occurred at 3 months and the active arm was followed to 12 months for International Prostate Symptom Score, peak flow rate, and sexual function using the International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function. The minimal clinically important difference in erectile function perceived by subjects as beneficial was determined for each erectile function severity category. Subjects not sexually active were censored from sexual function analysis. Results: No treatment- or device-related de novo erectile dysfunction occurred after thermal therapy. International Index of Erectile Function and Male Sexual Health Questionnaire for Ejaculatory Function scores were not different from the control group at 3 months or from baseline at 1 year. Ejaculatory bother score improved 31{\%} over baseline (P = .0011). Also, 32{\%} of subjects achieved minimal clinically important differences in erectile function scores at 3 months, and 27{\%} at 1 year, including those with moderate to severe erectile dysfunction. International Prostate Symptom Score and peak flow rate were significantly superior to controls at 3 months and throughout 1 year (P <.0001). Conclusion: Convective water vapor thermal therapy provides sustainable improvements for 12 months to lower urinary tract symptoms and urinary flow while preserving erectile and ejaculatory functions.",
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AU - Gittelman, Marc C.

AU - Goldberg, Kenneth Allen

AU - Patel, Kalpesh

AU - Shore, Neal D.

AU - Levin, Richard M.

AU - Rousseau, Michael

AU - Beahrs, J. Randolf

AU - Kaminetsky, Jed

AU - Cowan, Barrett E.

AU - Cantrill, Christopher H.

AU - Mynderse, Lance A.

AU - Ulchaker, James C.

AU - Larson, Thayne R.

AU - Dixon, Christopher M.

AU - Roehrborn, Claus

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N2 - Introduction: Most surgical treatments for male lower urinary tract symptoms and benign prostatic hyperplasia affect erectile and ejaculatory functions negatively, leading to patient dissatisfaction. Aim: To determine whether water vapor thermal therapy, when conducted in a randomized controlled trial, would significantly improve lower urinary tract symptoms secondary to benign prostatic hyperplasia and urinary flow rate while preserving erectile and ejaculatory functions. Methods: Men at least 50 years old with International Prostate Symptom Scores of at least 13, a peak flow rate of at least 5 to no higher than 15 mL/s, and prostate volume of 30 to 80 cm3 were randomized 2:1 between Rezūm System thermal therapy and control. Thermal water vapor (103°C) was injected into lateral and median lobes as required for treatment of benign prostatic hyperplasia. The control procedure entailed rigid cystoscopy with simulated active treatment sounds. Main Outcome Measures: Blinded group (active = 136, control = 61) comparison occurred at 3 months and the active arm was followed to 12 months for International Prostate Symptom Score, peak flow rate, and sexual function using the International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function. The minimal clinically important difference in erectile function perceived by subjects as beneficial was determined for each erectile function severity category. Subjects not sexually active were censored from sexual function analysis. Results: No treatment- or device-related de novo erectile dysfunction occurred after thermal therapy. International Index of Erectile Function and Male Sexual Health Questionnaire for Ejaculatory Function scores were not different from the control group at 3 months or from baseline at 1 year. Ejaculatory bother score improved 31% over baseline (P = .0011). Also, 32% of subjects achieved minimal clinically important differences in erectile function scores at 3 months, and 27% at 1 year, including those with moderate to severe erectile dysfunction. International Prostate Symptom Score and peak flow rate were significantly superior to controls at 3 months and throughout 1 year (P <.0001). Conclusion: Convective water vapor thermal therapy provides sustainable improvements for 12 months to lower urinary tract symptoms and urinary flow while preserving erectile and ejaculatory functions.

AB - Introduction: Most surgical treatments for male lower urinary tract symptoms and benign prostatic hyperplasia affect erectile and ejaculatory functions negatively, leading to patient dissatisfaction. Aim: To determine whether water vapor thermal therapy, when conducted in a randomized controlled trial, would significantly improve lower urinary tract symptoms secondary to benign prostatic hyperplasia and urinary flow rate while preserving erectile and ejaculatory functions. Methods: Men at least 50 years old with International Prostate Symptom Scores of at least 13, a peak flow rate of at least 5 to no higher than 15 mL/s, and prostate volume of 30 to 80 cm3 were randomized 2:1 between Rezūm System thermal therapy and control. Thermal water vapor (103°C) was injected into lateral and median lobes as required for treatment of benign prostatic hyperplasia. The control procedure entailed rigid cystoscopy with simulated active treatment sounds. Main Outcome Measures: Blinded group (active = 136, control = 61) comparison occurred at 3 months and the active arm was followed to 12 months for International Prostate Symptom Score, peak flow rate, and sexual function using the International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function. The minimal clinically important difference in erectile function perceived by subjects as beneficial was determined for each erectile function severity category. Subjects not sexually active were censored from sexual function analysis. Results: No treatment- or device-related de novo erectile dysfunction occurred after thermal therapy. International Index of Erectile Function and Male Sexual Health Questionnaire for Ejaculatory Function scores were not different from the control group at 3 months or from baseline at 1 year. Ejaculatory bother score improved 31% over baseline (P = .0011). Also, 32% of subjects achieved minimal clinically important differences in erectile function scores at 3 months, and 27% at 1 year, including those with moderate to severe erectile dysfunction. International Prostate Symptom Score and peak flow rate were significantly superior to controls at 3 months and throughout 1 year (P <.0001). Conclusion: Convective water vapor thermal therapy provides sustainable improvements for 12 months to lower urinary tract symptoms and urinary flow while preserving erectile and ejaculatory functions.

KW - Benign Prostatic Hyperplasia

KW - Ejaculatory Dysfunction

KW - Erectile Dysfunction

KW - Lower Urinary Tract Symptoms

KW - Sexual Function

KW - Thermal Therapy

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