Treating BPH: Comparing Rezum UroLift and HoLEP Scott M. Cheney MD Mayo Clinic Arizona 2018 MFMER slide-1
Welcome to AZ 2018 MFMER slide-2
Outline Background on BPH, Rezum, Urolift, HoLEP AUA Guideline Statements Level of Evidence Comparative Outcomes Functional Sexual Complications Durability/Retreatment Decision-Making 2018 MFMER slide-3
Disclosures None 2018 MFMER slide-4
Audience Question #1 What is the gold standard for surgical treatment of BPH? 1. Urolift 2. Rezum 3. TURP 4. Green Light PVP 5. HoLEP/ThuLEP 6. Other 2018 MFMER slide-5
Background 2018 MFMER slide-6
BPH Disease Prevalence 15 million men >30y affected by BPH Lee Eur Urol 1998 Olmstead County Study 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% Moderate-Severe LUTS (AUA > 7) 40-49y 50-59y 60-69y 70-79y Chute J Urol 1993 2018 MFMER slide-7
Definitions MIST- Minimally Invasive Surgical Therapy Urolift- Prostatic Urethral Lift PUL Rezum- Water Vapor Thermal Therapy Definitive Therapy- Tissue removal HoLEP- Holmium Laser Enucleation of the Prostate Comparing apples to apples? 2018 MFMER slide-8
BPH Treatment Options Observation Dietary Supplements Medication Alpha Blockers 5-ARI PDE-5I Minimally Invasive Surgery TUMT TUNA Rezum (Steam vapor) UroLift Definitive Surgery TURP TUIP HoLAP PVP (Green light) HoLEP/ThuLEP Open Simple Prostatectomy Robotic Simple Prostatectomy 2018 MFMER slide-9
MIST Rezum (NxThera, Maple Grove, MN) Radiofrequency energy à Steam à Tissue Necrosis à Decreased TZ Volume FDA approval August 2015 Can be used on median lobe 2018 MFMER slide-10
MIST Urolift (Neotract, Pleasanton, CA) FDA Approval Sept 2013 Ideal for patients without median lobe 2018 MFMER slide-11
Definitive Therapy HoLEP First Described 1995 Gilling J Endourol 1995 All prostate sizes, configurations Adenoma separated from prostate capsule Enucleated tissue morcellated in the bladder Fraundorfer, Gilling. Eur Urol 1998 2018 MFMER slide-12
2018 AUA Guideline Statements Urolift 14. Clinicians should consider PUL (Prostatic Urethral Lift) as an option for patients with LUTS attributed to BPH provided prostate volume <80 and verified absence of an obstructive middle lobe; however, patients should be informed that symptom reduction and flow rate improvement is less significant compared to TURP. (Grade C, Moderate Recommendation) 15. PUL may be offered to eligible patients concerned with erectile and ejaculatory function for the treatment of with LUTS attributed to BPH. (Grade C, Conditional Recommendation) 2018 MFMER slide-13
2018 AUA Guideline Statements Rezum 17. Water vapor thermal therapy (Rezum) may be offered to patients with LUTS attributed to BPH provided prostate volume <80g; however, patients should be informed that evidence of efficacy, including longer-term retreatment rates, remains limited. (Grade C, Conditional Recommendation) 18. Water vapor thermal therapy may be offered to eligible patients who desire preservation of erectile and ejaculatory function. (Grade C, Conditional Recommendation) 2018 MFMER slide-14
2018 AUA Guideline Statements HoLEP 20. Clinicians should consider holmium laser enucleation of the prostate (HoLEP) or thulium laser enucleation of the prostate (ThuLEP), depending on their expertise with either technique, as prostate size-independent suitable options for the treatment of LUTS attributed to BPH. (Grade B, Moderate Recommendation) 22. HoLEP, PVP, and ThuLEP should be considered in patients who are at higher risk of bleeding, such as those on anti-coagulation drugs. (Expert Opinion) 2018 MFMER slide-15
Level of Evidence Urolift Years of experience- 5 Randomized trials- 2 Rezum Years of experience- 3 Randomized trials- 1 HoLEP Years of experience- 20 Randomized trials- 31 2018 MFMER slide-16
Audience Question #2 What is the most important factor the patient considers when choosing type of BPH surgery? 1. Efficacy/ Degree of improvement 2. Risk of sexual side effects (ED, EjD) 3. Risk of retreatment 4. Risk of incontinence 5. Time of catheterization 6. Cost 2018 MFMER slide-17
Audience Question #3 What is the most important factor the surgeon considers when choosing BPH surgery? 1. Efficacy/ Degree of improvement 2. Risk of sexual side effects (ED, EjD) 3. Risk of retreatment 4. Risk of incontinence 5. Time of catheterization 6. Cost 2018 MFMER slide-18
Outcomes 2018 MFMER slide-19
Functional Outcomes IPSS UroLift Rezum HoLEP Baseline (out of 35) 22 22 26 3mo -11-11 -21 12mo -10-12 -21 Long Term -8 (60 mo) -11 (36 mo) -18 (92 mo) Roehrborn (L.I.F.T.) Can J Urol 2017 Gratzke BJUI (BPH6) 2017 McVary Urol 2018 Gilling BJUI 2011 2018 MFMER slide-20
Functional Outcomes IPSS-QOL UroLift Rezum HoLEP Baseline (out of 6) 4-5 4.4 4.8 3mo -2.5-2.1-3.0 12mo -2.5-2.2-3.3 Long Term -2.1 (60 mo) -2.2 (36 mo) -3.3 (92 mo) Roehrborn (L.I.F.T.) Can J Urol 2017 Gratzke BJUI (BPH6) 2017 McVary Urol 2018 Gilling BJUI 2011 2018 MFMER slide-21
Functional Outcomes Qmax UroLift Rezum HoLEP Baseline (ml/s) 8-9 10 8 3mo +4 +6.4 +16 12mo +4 +5.5 +13 Long Term +3 (60 mo) +3.5 (36 mo) +14 (92 mo) Roehrborn (L.I.F.T.) Can J Urol 2017 Gratzke BJUI (BPH6) 2017 McVary Urol 2018 Gilling BJUI 2011 2018 MFMER slide-22
Sexual Outcomes Urolift No de novo ED Same or improved ejaculatory function No change in IIEF or MSHQ- EjD scores Rezum No de novo ED 2% pts with reduced ejaculatory volume No change in IIEF or MSHQ- EjD scores AUA BPH Guideline 2018 AUA BPH Guideline 2018 HoLEP IIEF- Erection (out of 30) : Baseline 22.3 à 23.8 (1y) IIEF- Orgasm (out of 10): Baseline 8.5 à 6.5 (1y) IIEF- Overall Satisfaction (out of 10): Baseline 7.2 à 7.1 (1y) Montorsi J Urol 2008 Retrograde Ejaculation 74-85% Krambeck Curr Op Urol 2018 2018 MFMER slide-23
Complications UroLift Rezum HoLEP SUI NR NR 1.3-44% (3mo) 1% (>1y) Urgency/UUI 3% 5.9% 44% Dysuria 9% 16.9% 59% Acute Retention 0.4% 3.7% 5.3% Stricture <0.01% 0 0.5-8.1% (1y) Transfusion NR NR 1.6% Roehrborn Can J Urol 2017 McVary Urol 2018 Krambeck Curr Op Urol 2018, Montorsi J Urol 2008 2018 MFMER slide-24
Retreatment Rate Urolift Surgery for BPH symptom recurrence- 19/140 (13.5% at 5 years) Removal encrusted implants- 10/140 (7.1%) Removal implants in bladder- 3/140 (2.1%) Restarted alpha blocker/5-ari- 15/140 (10.7%) AUA BPH Guidelines 2018 Rezum Surgery for BPH symptom recurrence- 6/135 (4.4% at 3 years) HoLEP McVary Urol 2018 Surgery for symptomatic residual/adenoma regrowth- 0.5% Krambeck Curr Op Urol 2018 2018 MFMER slide-25
Special Considerations Length of catheterization Urolift- 0.9d Roehrborn Can J Urol 2017 Rezum- 4.1d Dixon Res Rep Urol 2016 HoLEP- 18h Gilling BJUI 2011 Learning Curve Urolift- 5 cases Roehrborn Interview Uro Today 2017 Rezum- 5-10 cases NxThera Website HoLEP- 20-50 cases Krambeck Curr Op Urol 2018 Anesthesia Rezum/Urolift- Local or General HoLEP- General Only, 125min operative time Krambeck Curr Op Urol 2018 2018 MFMER slide-26
Cost Ulchaker ClinicoEcon 2018 2018 MFMER slide-27
Decision Making 2018 MFMER slide-28
Definitive Therapy HoLEP Invasiveness Medical Therapy 5-ARI α-blockers Qmax- +2.4mL/s IPSS- -6.3 AUR/BPH Surgery- 11.9% Incontinence- 3% EjD- 17% MIST Rezum Urolift Qmax- +3.5mL/s IPSS- -8-11 Def Surgery- 4.4-13.5% Incontinence- 0% EjD- 0-2% Qmax- +14mL/s IPSS- -18 Retreatment- 0.5% Incontinence- 1-3% EjD- 80% Roehrborn BJUI 2018, Montorsi (CombAT) BJUI 2011, Roehrborn (CombAT) Eur Urol 2010, Effectiveness 2018 MFMER slide-29
2018 MFMER slide-30
Summary Must weigh efficacy, invasiveness, cost, skill-set Urolift and Rezum have similar efficacy, low complication rate, reasonable durability Urolift and Rezum preserve sexual/ejaculatory function Urolift and Rezum should be used for prostate volume <80gm HoLEP has higher efficacy and lower retreatment rate, but is more invasive and has more side effects HoLEP can be used for any size prostate HoLEP should be considered for patients with higher bleeding risk 2018 MFMER slide-31
Conclusion Every urologist should have several surgical tools at his/her disposal to address unique patient considerations: Symptoms, Anatomy, Efficacy, Comorbidities, Side Effects 2018 MFMER slide-32
References American Urological Association Guideline: Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (2018). https://www.auanet.org/guidelines/benign-prostatic-hyperplasia/lower-urinary-tract-symptoms-(2018)#x8218 Chute C, Panser L, et al. The prevalence of prostatism: a population-based survey of urinary symptoms. J Urol. 1993;150(1):85. Dixon C, Edwin R, et al. Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia. Res Rep Urol 2016:8: 207-216. Gilling P, Wilson L, et al. Long-term results of a randomized trial comparing holmium laser enucleation of the prostate and transurethral resection of the prostate: results at 7 years. BJUI 2011;109:408-411. Gratzke C, Barber N, et al. Prostatic urethral lift vs transurethral resection of the prostate: 2-year results of the BPH6 prospective, multicentre, randomized study. BJUI 2017;119:767-775. Large T, Krambeck A. Evidence-based outcomes of holmium laser enucleation of the prostate. Curr Op Urol 2018;28:301-308. Lee A, Garraway W, Simpson R, et al. The natural history of untreated lower urinary tract symptoms in middle-aged and elderly men over a period of five years. Eur Urol 1998;34:325 32. McVary K, Roehrborn C. Rezum System Study: Convective Radiofrequency Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Urology 2018;111:1-9. Montorsi F, Naspro R, et al. Holmium laser enucleation versus transurethral resection of the prostate: Results from a 2-center, prospective, randomized trial in patients with obstructive benign prostatic hyperplasia. J Urol 2008;179: S87 S90. Montorsi F, Roehrborn C, et al. The effects of dutasteride or tamsulosin alone and in combination on storage and voiding symptoms in men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH): 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study. BJUI 2011;107: 1426-1431. Roehrborn C, Barkin J, et al. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol 2017; 24(3): 8802-8813. Roehrborn C. AUA 2017: Minimally Invasive Prostatic Urethral Lift (PUL) Produces Durable Symptom Improvement in Lower Urinary Tract Symptoms: Interview with Claus Roehrborn. Uro Today. https://www.urotoday.com/conference-highlights/aua-2017/aua-2017- bph/95787-minimally-invasive-prostatic-urethral-lift-pul-produces-durable-symptom-improvement-in-lower-urinary-tract-infectionsinterview-with-claus-roehrborn.html Roehrborn C, Manyak M, et al. A prospective randomised placebo-controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJUI 2018; 121: 647-658. Roehrborn C, Siami P, et al. The Effects of Combination Therapy with Dutasteride and Tamsulosin on Clinical Outcomes in Men with Symptomatic Benign Prostatic Hyperplasia: 4-Year Results from the CombAT Study. Eur Urol 2010;57: 123-131. Ulchaker J, Martinson M. Cost-effectiveness analysis of six therapies for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Clin Econ Outc Res 2018;10 29-43. 2018 MFMER slide-33
Thank you! 2018 MFMER slide-34