Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH.

INTRODUCTION: To determine if Aquablation therapy can maintain long term effectiveness in treating men with moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with a baseline prostate volume between 30 and 80 mL at 5 years compared to TURP. MATERIALS AND METHODS: In a double-blinded, multicenter prospective randomized controlled trial, 181 patients with moderate to severe LUTS secondary to BPH underwent TURP or Aquablation. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo persistent Grade 1 or Grade 2 or higher operative complications at 3 months. The assessments included IPSS, Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function (IIEF) and uroflow (Qmax). The patients were followed for 5 years. RESULTS: The primary safety endpoint was successfully achieved at 3 months where the Aquablation group had a lower event rate than TURP (26% vs. 42%, p = .0149 for superiority). Procedure-related ejaculatory dysfunction was lower for Aquablation (7% vs. 25%, p = .0004). The primary efficacy endpoint was successfully achieved at 6 months, where the mean IPSS decreased from baseline by 16.9 points for Aquablation and 15.1 points for TURP; the mean difference in change score at 6 months was 1.8 points larger for Aquablation (p < .0001 for non-inferiority, p = .1346 for superiority). At 5 years, IPSS scores improved by 15.1 points in the Aquablation group and 13.2 points in TURP (p = .2764). However, for men with larger prostates (≥ 50 mL), IPSS reduction was 3.5 points greater across all follow up visits in the Aquablation group compared to the TURP group (p = .0123). Improvement in peak urinary flow rate was 125% and 89% compared to baseline for Aquablation and TURP, respectively. The risk of patients needing a secondary BPH therapy, defined as needing BPH medication or surgical intervention, up to 5 years due to recurrent LUTS was 51% less in the Aquablation arm compared to the TURP arm. CONCLUSIONS: The improvement in net health outcomes from Aquablation therapy outweigh those offered by a TURP when considering the efficacy benefit along with the lower risk of needing a secondary BPH therapy and avoiding retrograde ejaculation. Following Aquablation therapy, symptom reduction and uroflow improvement at 5 years have shown to be durable and consistent across all years of follow up compared to TURP. Larger prostates (≥ 50 mL) demonstrated a larger safety and efficacy benefit for Aquablation over TURP.

The Evolution of Endoscopic Prostate Enucleation: A historical perspective.

Here, we review the evolution of prostate enucleation in chronological order based on energy technology starting first with holmium laser, then bipolar electrocautery, followed by thulium laser and finally greenlight and diode laser enucleation of the prostate.

Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes.

OBJECTIVE: To report 1-year safety and efficacy outcomes after either Aquablation or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia (BPH) METHODS: This double-blinded, multicenter prospective randomized controlled trial assigned 181 patients with BPH-related moderate-to-severe lower urinary tract symptoms to either electrocautery-based prostate resection (TURP) or Aquablation. Efficacy endpoints included reduction in International Prostate Symptom Score and improvement in uroflow parameters. The primary safety endpoint was the occurrence of Clavien-Dindo persistent grade 1 or grade 2 or higher complications. RESULTS: BPH symptom score improvements were similar across groups with 12-month reduction of 15.1 points after TURP or Aquablation. In both groups, mean maximum urinary flow rates increased markedly postoperatively, with mean improvements of 10.3 cc/s for Aquablation versus 10.6 cc/s for TURP (P = .8632). At 1 year, Prostate-specific antigen (PSA) was reduced significantly (P < .01) in both groups by 1 point; the reduction was similar across groups (P = .9125). Surgical retreatment for BPH rates for TURP were 1.5% and Aquablation 2.6% within 1 year from the study procedure (P = not significant (NS)). The rate of late complications was low, with no procedure-related adverse events after month 6. CONCLUSION: The 1-year outcomes after TURP and Aquablation were similar and the rate of late procedure-related complications was low. (ClinicalTrials.gov number, NCT02505919).

HoLEP has come of age.

INTRODUCTION: Lower urinary tract symptoms (LUTS) are a common complaint and although can be adequately managed with medication, surgery remains the mainstay of treatment. Transurethral resection has been the reference 'gold standard', but due to its complications and issues with larger volume prostates, many alternatives have been developed and assessed. Holmium laser enucleation of the prostate (HoLEP) has shown excellent efficacy, durability and safety and has become an important alternative that has gained guideline approval. RESULTS: HoLEP has been shown to have outcomes that are equivalent or better than TURP in both urodynamic measurements and symptom scores. Its outcomes have been proven to be durable and cost-effective. HoLEP has fewer and less serious complications when compared to the current reference standard, its use also allows earlier removal of catheter and hospital discharge. Appropriate mentoring reduces many of the issues associated with the steep learning curve, thus removing the main hurdle to its widespread adoption as the surgical treatment of choice for LUTS due to benign prostatic hyperplasia (BPH). CONCLUSIONS: HoLEP fulfils all of the requirements as an alternative/replacement for TURP and open prostatectomy, with equivalent outcomes and reduced complications. With improvements in the learning curve, it could now be considered the true gold standard surgical treatment for BPH. HoLEP has come of age.

In 2013, holmium laser enucleation of the prostate (HoLEP) may be the new 'gold standard'.

In this review article, we assess why holmium laser enucleation of the prostate (HoLEP) has become an important treatment modality for benign prostatic hypertrophy (BPH). Meta-analysis comparing HoLEP with both open prostatectomy (OP) and transurethral resection of prostate (TURP) shows TURP to be as effective with less morbidity. More recently, HoLEP has long-term durability data confirming a very low reoperation rate. This article investigates how previous hurdles to the widespread uptake of HoLEP have been overcome. Recent literature shows that the learning curve is actually similar to many other current urological procedures, and that the efficiency of HoLEP is equal to that of other surgical procedures. HoLEP is also beneficial in the growing population of men on anticoagulation who require treatment for BPH. Finally, HoLEP is the only laser treatment for BPH with level 1 evidence and endorsement in both the American Urological Association (AUA) and European Association of Urology (EAU) guidelines.

Long-term results of a randomized trial comparing holmium laser enucleation of the prostate and transurethral resection of the prostate: results at 7 years.

OBJECTIVE: To assess the durability of holmium laser enucleation of prostate in comparison to transurethral resection of the prostate (TURP). PATIENTS AND METHODS: Patients were enrolled in the present study between June 1997 and December 2000 and followed per protocol. All patients were urodynamically obstructed with a prostate volume of between 40 and 200 mL. At long-term follow-up, variables assessed included Benign Prostatic Hyperplasia Impact Index (BPHII), International Continence Society Short Form Male questionnaire (ICSmale-SF) and the International Index of Erectile Function (IIEF). Adverse events, including the need for retreatment, were specifically assessed. RESULTS: Thirty-one (14 holmium laser enucleation of the prostate [HoLEP] and 17 TURP) of the initial 61 patients were available, with 12 deceased and 18 lost to follow-up. The mean (range) follow-up was 7.6 (5.9-10.0) years and the mean (±sd) age at follow-up was 79.8 (±6.2) years. The mean (±sd) values (HoLEP vs TURP) were as follows: maximum urinary flow rate (Q(max)), 22.09 ± 15.47 vs 17.83 ± 8.61 mL/s; American Urological Association (AUA) symptom score, 8.0 ± 5.2 vs 10.3 ± 7.42; quality of life (QOL) score 1.47 ± 1.31 vs 1.31 ± 0.85; BPHII, 1.53 ± 2.9 vs 0.58 ± 0.79; IIEF-EF (erectile function), 11.6 ± 7.46 vs 9.21 ± 7.17; ICSmale Voiding Score (VS), 4.2 ± 3.76 vs 3.0 ± 2.41; ICSmale Incontinence Score (IS), 3.07 ± 3.3 vs 1.17 ± 1.4. There were no significant differences in any variable between the two groups beyond the first year. Of the assessable patients, none required re-operation for recurrent BPH in the HoLEP arm and three (of 17) required re-operation in the TURP arm . CONCLUSION: The results of this randomized trial confirm that HoLEP is at least equivalent to TURP in the long term with fewer re-operations being necessary.

A double-blind randomized controlled trial of electromagnetic stimulation of the pelvic floor vs sham therapy in the treatment of women with stress urinary incontinence.

OBJECTIVE: To compare the efficacy of extracorporeal electromagnetic stimulation (ES) of the pelvic floor for treating stress urinary incontinence (SUI) vs sham ES. PATIENTS AND METHODS: In all, 70 women with urodynamically confirmed SUI were randomized to receive active (35) or sham (35) ES. The NeoControl chair (NeoTonus, Marietta, GA, USA) was used, and treatment consisted of three sessions per week for 6 weeks. data were collected before and after treatment on all women, including a 20-min provocative pad-test with a predetermined bladder volume (primary outcome measure), a 3-day bladder diary and 24 h pad-test. Circumvaginal muscle (CVM) rating score, perineometry using two separate instruments and video-urodynamics were also used, and the Urinary Incontinence Quality of Life Scale (I-QOL) and King's Health Questionnaires. Patients were fully re-evaluated 8 weeks after treatment, and the bladder diary, pad-test and questionnaires were repeated at 6 months. The urotherapist and physician were unaware to which treatment group the patient was assigned. RESULTS: In the overall group of 70 patients there were significant improvements in each of the primary and secondary outcome measures at 8 weeks. There were also significant improvements in primary and secondary outcome measures in the active treatment group when compared with baseline measures. At 8 weeks, there were improvements in the mean (sd) values for the 20-min pad-test, of 39.5 (5.1) vs 19.4 (4.6) g (P < 0.001); the 24-h pad-test, of 24.0 (4.7) vs 10.1 (3.1) g (P < 0.01); the number of pads/day, of 0.9 (0.1) vs 0.6 (0.1) (P < 0.01), the I-QOL score, of 63.7 (2.8) vs 71.2 (3.3) (P < 0.001); and King's Health Questionnaire score, of 9.6 (0.8) vs 6.9 (0.7) (P < 0.001). However, these improvements were not statistically significant when compared with the sham-treatment group. In those patients on active treatment who had a poor pelvic floor contraction at the initial assessment (defined by the CVM score and perineometry), there was a significant reduction (P < 0.05) in the 20-min pad-test leakage when compared with the sham-treatment group. CONCLUSIONS: ES was no more effective overall than sham treatment in this patient group. However, in those women who were unable to generate adequate pelvic floor muscle contractions, there was an objective improvement in provocative pad testing when compared to sham treatment.

Current techniques for laser prostatectomy -PVP and HoLEP / Técnicas actuales para la prostatectomía láser-PVP y HoLEP

Objectives: The objective of this review is to provide an evidence-based update on laser surgery for BPH with a focus on comparing Greenlight Photoselective Vaporisation of the Prostate (PVPj to Holmium Laser Enucleation of the Prostate (HoLEP). Methods: We reviewed all HoLEP and PVP papers identified by a Pubmed search using the keywords: laser, prostate, BPH, holmium, HoLEP, PVP and greenlight. The published randomised trials investigating HoLEP and PVP are summarised. As there are no head to head randomised trials comparing HoLEP to PVP, we compare data from individual HoLEP and PVP papers. Data on multiple aspects of laser surgery for BPH are summarised and contrasted for the 2 procedures including: Perioperative management, subjective and objective measures of success, complications, sexual function, prostate volume reduction, durability, and surgery for men with large prostates and those in urinary retention. Results/Conclusions: PVP and HoLEP are very different laser techniques. An important difference between the Green-light laser and holmium and thulium is that its only urological application is prostate ablation. HoLEP is the most advanced laser technique currently available. In contrast to PVP, it has been rigorously evaluated in 8 randomised trials. It is a size independent procedure suitable for any prostate, and highly effective at treating urinary retention. HoLEP has been reported to be durable to periods up to 6 years. More tissue is removed with HoLEP than PVP, and this raises concerns regarding the long term durability of PVP for which there is no comparable data. The increase in HoLEP expertise world-wide and the development of lasers that are faster at ablating tissue and have other urological uses (eg thulium) may threaten the longevity of Greenlight PVP (AU)

Objetivo: El objetivo de ésta revisión es ofrecer una puesta al día basada en la evidencia sobre cirugía láser para el tratamiento de la HBP, enfocada a la comparación entre vaporización fotoselectiva con láser verde (PVP) y la enucleación prostática con láser de Holmio(HoLEP). Métodos: Revisamos todos los artículos sobre HoLEP y PVP identificados en una búsqueda bibliográfica en PubMed utilizando los términos: láser, próstata, HBP, Holmio, HoLEP, PVP, y luz verde. Como no existen ensayos clínicos aleatorizados comparando directamente HoLEP y PVP comparamos los datos de artículos individuales de cada técnica. Se resumen y contrastan los datos de múltiples aspectos de la cirugía láser de la HBP mediante ambos procedimientos incluyendo: manejo perioperatorio, medidas objetivas y subjetivas de éxito, complicaciones, función sexual, reducción del volumen prostático, durabilidad y cirugía en varones con próstatas grandes y pacientes con retención urinaria. Resultados/Conclusiones: La PVP y la HoLEP son técnicas láser muy diferentes. Una diferencia importante entre el láser de luz verde y los de Holmio o Tulio es que su única aplicación es la ablación prostática. La técnica de enucleación con láser de Holmio es la técnica láser más avanzada disponible actualmente. En contraste con la fotovaporización ha sido rigurosamente evaluada en ocho ensayos clínicos. Es un procedimiento independiente del tamaño prostático, válido para cualquier próstata, altamente eficaz en el tratamiento de la retención urinaria. Se ha comunicado que la enucleación prostática con láser de Holmio es duradera hasta seis años. Se quita más tejido con la HOLEP y con la PVP y esto suscita una preocupación en cuanto a la duración a largo plazo del resultado de la PVP, de la que no existen datos comparables. El aumento de la experiencia con HoLEP en todo el mundo y el desarrollo de láseres más rápidos en la ablación de tejidos y con otros usos urológicos (Ej tulio) puede amenazar la supervivencia de la PVP con láser de luz verde (AU)

A randomised trial comparing holmium laser enucleation versus transurethral resection in the treatment of prostates larger than 40 grams: results at 2 years.

OBJECTIVE: To compare holmium laser enucleation of the prostate (HoLEP) with transurethral resection of the prostate (TURP) for treatment of men with bladder outflow obstruction (BOO) secondary to benign prostatic hyperplasia with a minimum of 24-month follow-up. PATIENTS AND METHODS: Sixty-one patients were randomised to either HoLEP or TURP. All patients had BOO proven on urodynamic studies pre-operatively (prostate size 40-200 g). One patient died before treatment, which left 30 patients in each group. Perioperative data, as well as symptom scores, Quality of Life (QoL) scores, and maximum urinary flow rates (Qmax) were obtained at one, three, six,12, and 24 months. Post-void residual volumes, transrectal ultrasound (TRUS) volumes, and pressure flow studies were obtained six months post-operatively. Continence and potency data were also recorded. RESULTS: There were no significant differences between the two surgical groups pre-operatively. Mean pre-operative TRUS volume was 77.8+/-5.6 g (42-152) in the HoLEP group and 70.0+/-5.0 g (46-156) in the TURP group. Patients in the HoLEP group had shorter catheter times and hospital stays. More prostate tissue was retrieved in the HoLEP group. At six months, HoLEP was urodynamically superior to TURP in relieving BOO. At 24 months, there was no significant difference between the two surgical groups with respect to American Urology Association scores, QoL scores, or Qmax values; however, two patients in the TURP group required re-operation. CONCLUSIONS: HoLEP has less perioperative morbidity and produces superior urodynamic outcomes than TURP, when treating prostates >40 g. At 24 months of follow-up, HoLEP is equivalent to TURP.

Free-beam and contact laser soft-tissue ablation in urology.

The ablation of tissue by laser has several applications in urology. Most of the published research has been concerned with the treatment of benign prostatic hyperplasia (BPH). Other applications studied include superficial upper- and lower-tract transitional-cell carcinoma, urethral and ureteral strictures, ureteropelvic junction stenosis, and posterior urethral valves. The attraction of laser ablation for the treatment of BPH lies with the decreased morbidity in comparison with standard transurethral electrocautery resection of the prostate and the ability to remove tissue immediately and therefore allow a more rapid progression to catheter removal and early voiding. The three main laser wavelengths used in urology for tissue ablation are the neodymium:yttrium-aluminum-garnet when used with contact tips or high-density power settings, the potassium-titanyl-phosphate, and the holmium:YAG. This article reviews the published literature on the use of these laser wavelengths in soft-tissue ablation, focusing on the treatment of BPH.