Pilot Study of "Less is More" Rezum for Treatment of BPH.

OBJECTIVE: To assess the outcomes of a "less is more" treatment approach consisting of a single water vapor treatment per prostate lobe for benign prostatic hyperplasia (BPH). METHODS: Retrospective cohort study in a single urologic clinic of men with moderate to severe symptomatic BPH with and without median lobes undergoing thermal water vapor therapy. Single injection of thermal water vapor was given in each prostate lobe. The primary endpoint compared maximum urine flow rate (Qmax), post-void residual (PVR), International Prostatism Symptom Score (IPSS), and the IPSS Quality of Life scale (IPSS QoL) at baseline and at 1, 3, 6, and 12 months. RESULTS: The study included 52 men with mean prostate volume and IPSS of 52.8cc and 20.3cc, respectively. IPSS was reduced by -3.95 ± 7.5 at 3 months (P = .02875), -8.5 ± 9.3 at 6 months (P = .01767), and -11.63 ± 8.4 at 12 months (P = .005908). IPSS QoL improved by -1.75 ± 1.2 t 12 months (P = .003799) and QMax by 5.36 ± 3.7 mL/s at 12 months (P = .008445). Time to post-operative catheter removal was 3.5 ± 1.3 days. One patient reported ejaculatory dysfunction. All other adverse events were mild to moderate in severity and resolved quickly. CONCLUSION: Thermal water vapor therapy with single injection per lobe is both an effective and safe treatment for BPH that provides comparable improvements in lower urinary tract symptoms and quality of life to the traditional approach that employed variable number of injections by prostate volume.

Estimation of Urinary Frequency: Does Question Phrasing Matter?

PURPOSE: To evaluate if question phrasing and patient numeracy impact estimation of urinary frequency. MATERIALS AND METHODS: We conducted a prospective study looking at reliability of a patient interview in assessing urinary frequency. Prior to completing a voiding diary, patients estimated daytime, and nighttime frequency in 3 ways: (1) how many times they urinated (2) how many hours they waited in between urinations (3) how many times they urinated over the course of 4 hours. Numeracy was assessed using the Lipkus Numeracy Scale. RESULTS: Seventy-one patients completed the study. Correlation of estimates from questions 1, 2, and 3 to the diary were not statistically different. Prediction of nighttime frequency was better than daytime for all questions (correlation coefficients 0.751, 0.754, and 0.670 vs 0.596, 0.575, and 0.460). When compared to the diary, Question 1 underestimated (8.5 vs 9.7, P = .014) while Question 2 overestimated (11.8 vs 9.7, P = .027) recorded voids on a diary. All questions overpredicted nighttime frequency with 2.6, 2.9, and 3.9 predicted versus 1.6 recorded voids (P < .001). Although not statistically significant, for each question, the predicted frequency of numerate patients was more correlated to the diary than those of innumerate patients. CONCLUSION: When compared to a voiding diary for daytime urinary frequency, asking patients how many times they urinated underestimated, and asking patients how many hours they waited between urinations overestimated the number recorded voids. Regardless of phrasing, patients overestimated nighttime urination. Patients in our functional urology population have limited numeracy, which may impact accuracy of urinary frequency estimation.

Uso de la uroflujometría en el estudio de síntomas del tracto urinario bajo en pacientes masculinos. Hospital Central Universitario Dr. Antonio María Pineda / Use of uroflowmetry in the study of lower urinary tract symptoms in male patients. Central University Hospital Dr. Antonio María Pineda

La uroflujometría es un estudio no invasivo del tracto urinario inferior que entrega información objetiva del flujo urinario y es ampliamente recomendado por las guías europeas en el estudio de pacientes con sintomatología urinaria baja. Se realizó un estudio descriptivo transversal cuyo propósito fue describir el uso de la uroflujometría en el estudio de síntomas del tracto urinario bajo en pacientes masculinos que acudieron a la consulta de Servicio de Urología del Hospital Central Universitario Dr. Antonio María Pineda de la ciudad de Barquisimeto, estado Lara durante el lapso 2018- 2019. La muestra estuvo conformada por 150 pacientes. Los resultados indican que el 62% de la muestra corresponde a pacientes entre 60 y 70 años de edad de los cuales 52% manifestaron síntomas urinarios leves. La uroflujometría evidenció que 56% de los pacientes tienen un flujo máximo entre 10 y 20 ml/seg lo cual sugiere una probable obstrucción al flujo de salida; 78% de los pacientes presentan un flujo promedio entre 0 a 10 ml/seg. El 53% de los pacientes mostró un volumen de vaciado < 300 ml y 49% un tiempo de flujo máximo entre 30 y 50 segundos. En conclusión, la uroflujometría es un examen simple y rápido que proporciona información útil sobre la salud de las vías urinarias inferiores(AU)

Uroflowmetry is a non-invasive study of the lower urinary tract that provides objective information on urinary flow and is widely recommended by European guidelines for the study of patients with lower urinary tract symptoms. We performed a cross-sectional descriptive study to describe the use of uroflowmetry for the study of lower urinary tract symptoms in males who attended the Servicio de Urología of the Hospital Central Universitario Dr. Antonio María Pineda (Barquisimeto, Lara state) during the 2018- 2019 period. The sample was made up of 150 males. The results show that 62% of the sample included males between 60 and 70 years old and 52% complained of mild urinary symptoms. Uroflowmetry results showed that 56% of patients had a maximum flow between 10 and 20 ml/sec suggestive of urinary tract obstruction; 78% had an average flow between 0 and 10 ml/sec while 53% had a micturition volume < 300 ml and 49% had a maximum flow time between 30 and 50 seconds. Uroflowmetry is a simple and fast test which provides useful information about the health of lower urinary tract(AU)

Surgical Reintervention Rate after Prostatic Urethral Lift: Systematic Review and Meta-Analysis Involving over 2,000 Patients.

PURPOSE: The surgical reintervention rate after prostatic urethral lift is not well characterized but has been estimated at 2% to 3% per year. We performed a systematic review and meta-analysis to determine the surgical reintervention rate after prostatic urethral lift. MATERIALS AND METHODS: We systematically searched MEDLINE®, Embase® and the Cochrane Central Register of Controlled Trials for studies of men treated with prostatic urethral lift reporting at least 1 year of maximum followup data. We performed a random effects meta-analysis to estimate the annual rate of surgical reintervention after prostatic urethral lift, including those performed for lower urinary tract symptoms or involving device explant, additions or replacement. The robustness of the meta-analysis conclusions was evaluated in a one-study removed analysis and heterogeneity was investigated with a subgroup analysis. RESULTS: In 11 studies (2,016 patients) 153 surgical reinterventions were performed, among which transurethral resection of the prostate/laser (51.0%), repeat prostatic urethral lift (32.7%) and device explant (19.6%) were most common. The annual rate of surgical reintervention was 6.0% per year (95% CI 3.0-8.9). These results were not significantly influenced by any single study. The annual rate of surgical intervention was significantly influenced by the mean duration of patient followup. Surgical reintervention rates were 4.3% per year in studies with 1 year or less mean followup, 10.7% per year in studies with more than 1 year to 3 years mean followup and 5.8% per year in a single study with more than 3 years mean followup (p=0.04). CONCLUSIONS: The surgical reintervention rate with prostatic urethral lift is 6.0% per year and is higher in studies with longer followup durations.

Therapeutic use of pulsed electromagnetic field therapy reduces prostate volume and lower urinary tract symptoms in benign prostatic hyperplasia.

BACKGROUND: Benign prostatic hyperplasia (BPH) etiology remains poorly understood, but chronic low-grade inflammation plays a role. Pulsed electromagnetic field therapy (PEMF) (1-50 Hz) is effective in reducing tissue inflammation. OBJECTIVES: We designed a pilot study to evaluate the effects of PEMF on prostate volume (PV) in BPH. MATERIALS AND METHODS: This is a prospective interventional trial on 27 naive patients with BPH and lower urinary tract symptoms (LUTS). At baseline (V0 ), all patients had blood tests, transrectal ultrasound, and questionnaires (IPSS, IIEF-15) and received a perineal PEMF device (Magcell® Microcirc, Physiomed Elektromedizin). PEMF was delivered on perineal area 5 minutes twice daily for 28 days, then (V1 ) all baseline evaluations were repeated. Afterward, nine patients continued therapy for 3 more months (PT group) and 15 discontinued (FU group). A 4-month evaluation (V2 ) was performed in both groups. RESULTS: A reduction was observed both at V1 and at V2 in PV: PVV0 44.5 mL (38.0;61.6) vs PVV1 42.1 mL (33.7;61.5, P = .039) vs PVV2 41.7mL (32.7;62.8, P = .045). IPSS was reduced both at V1 and at V2 : IPSSV0 11 (5.7;23.2) vs IPSSV1 10 (6;16, P = .045) vs IPSSV2 9 (6;14, P = .015). Baseline IPSS was related to IPSS reduction both at V1 (rs  = 0.313;P = .003) and at V2 (rs  = 0.664;P < .001). PV reduction in patients without metabolic syndrome (ΔPVV1nMetS -4.7 mL, 95%CI -7.3;-2.0) was greater than in affected patients (ΔPVV1MetS 1.7 mL, 95%CI -2.69;6.1)(P = .017, Relative RiskMetS  = 6). No changes were found in gonadal hormones or sexual function. DISCUSSION: PEMF was able to reduce PV after 28 days of therapy. Symptoms improved in a short time, with high compliance and no effects on hormonal and sexual function or any side effects. Patients with moderate-severe LUTS and without MetS seem to benefit more from this treatment. CONCLUSION: PEMF reduces PV and improves LUTS in a relative short time, in BPH patients. These benefits seem greater in those patients with moderate-severe LUTS but without MetS.

Successful embolisation of pelvic fistulating vessels to the prostate arising after TURP - a rare cause of postoperative bleeding.

Transurethral resection of the prostate (TURP) is considered the gold-standard operation to treat lower urinary tract symptoms due to benign prostatic enlargement in men. Postoperative bleeding is a recognised complication and managing it is a core skill required by attending urologists. We report a rare case of postoperative bleeding caused by fistulating vessels to the prostate which developed after TURP. These fistulas arose from the right internal iliac vessels and communicated with pre-existing pelvic varices affecting the right paraprostaticand seminal vesicle tissues. The fistulating vessels were successfully embolised with liquid embolic agent. Surgeons should be aware that persisting haemorrhage can occur post-TURP from the rare presence of fistulating vessels communicating with pelvic varices. Early computed tomography angiographic assessment is warranted in cases where bleeding is prolonged and refractory to standard management in view of timely referral for percutaneous embolisation.

Comparación de los resultados clínicos en pacientes con Hiperplasia prostática benigna con tratamiento inicial Farmacológico, no farmacológico y quirúrgico, atendidos en el Hospital Pablo Arturo Suárez de enero 2014 a diciembre 2016 / Comparison of the clinical results in patients with benign prostatic hyperplasia with initial pharmacological, non-pharmacological and surgical treatment, managed at Pablo Arturo Suárez Hospital from january 2014 to december 2016

Contexto: Al momento existen pocos datos científicos que comparen las tres modalidades de tratamiento en Hiperplasia Prostática Benigna para determinar el mejor resultado clínico, considerando que se trata de una patología cuya incidencia aumenta a medida que aumenta la esperanza de vida poblacional. Objetivo: Comparar los resultados clínicos entre el tratamiento inicial farmacológico, no farmacológico y quirúrgico, basándose en la clínica de prostatismo en pacientes con Hiperplasia Prostática Benigna durante el período de enero 2014 a diciembre 2016. Diseño: Estudio Observacional, tipo Cohorte Retrospectiva. Pacientes y Métodos: Se procedió a dividir a 399 pacientes de acuerdo a la modalidad de tratamiento recibida. Se comparó la disminución del cuadro clínico en la primera consulta postratamiento utilizando una matriz de evaluación de síntomas urinarios elaborada por los autores, basada en la escala IPSS, que estratificó a los pacientes por el grado de severidad de la sintomatología. Se utilizó el software SPSS®. Resultados: Dentro del tratamiento no farmacológico, existió una diferencia de medias de 1,67 (IC 95% 0,49 ­ 2,85, p < 0,05); para el farmacológico fue de 0,21 (IC 95% 0,92 ­ 1,34, p = 0,713) y para el quirúrgico fue de 8,23 (IC 95% 7,19 ­ 9,27, p < 0,05). Se encontraron diferencias significativas entre los tres grupos durante la fase pretratamiento, tras estratificarlos de acuerdo al grado de severidad. Post- intervención, se compararon los resultados clínicos de cada tratamiento hallando que en pacientes con síntomas leves no existieron diferencias significativas (p = 0,087), no así para pacientes con sintomatología moderada y severa en donde se encontró una diferencia estadísticamente significativa. Conclusión: En pacientes con sintomatología urinaria catalogada como moderada y severa dentro de esta muestra, el tratamiento quirúrgico disminuyó la sintomatología urinaria en mayor proporción en comparación con el tratamiento farmacológico y el no farmacológico

Background: Currently there are few scientific data comparing the three therapeutic modalities of Benign Prostatic Hyperplasia to determine the best clinical outcome, considering that it is a pathology whose incidence increases as population life expectancy arise. Objectives: To compare the clinical results between the initial pharmacological, nonpharmacological and surgical treatment, based on clinical signs of prostatism in patients with benign prostatic hyperplasia during the period between January 2014 and December 2016. Study Design: Retrospective Cohort Study. Methods: 399 patients were divided according to the modality of treatment received: nonpharmacological, pharmacological and surgical. The decrease of the symptoms was compared with the first post-treatment consultation by using a matrix of evaluation of urinary symptoms elaborated by the authors, based on SPSS International Score; this tool stratified the patients by the severity of the symptomatology. SPSS® software was used. Results: Within the non-pharmacological treatment, there was a mean difference of 1.67 (95% CI 0.49 - 2.85, p <0.05); for the pharmacological it was 0.21 (95% CI 0.92 - 1.34, p = 0.713) and for the surgical was 8.23 (95% CI 7.19 - 9.27, p <0.05). Significant differences were found between the three groups during the pretreatment phase, after stratifying them according to the degree of severity. Post-intervention, the clinical results of each treatment were compared, finding that in patients with mild symptoms there were no significant differences (p = 0.087), not so for patients with moderate and severe symptoms where a statistically significant difference was found. Conclusion: In patients with urinary symptoms classified as moderate and severe within this sample, surgical treatment decreased urinary symptomatology in greater proportion compared to pharmacological and non-pharmacological treatment

Application of 180W XPS GreenLight laser vaporization of the prostate for treatment of benign prostatic hyperplasia.

PURPOSE: To evaluate safety, efficacy and clinical outcomes after photovaporization of the prostate with the 180W-XPS Greenlight laser in patients with low urinary tracts symptom secondary to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: All 102 patients with lower urinary tract symptoms who underwent 180W XPS laser vaporization of the prostate from April 2017 to April 2018 were enrolled. The preoperative parameters, postoperative functional, uroflowmetry outcomes and complications were collected. RESULTS: All patients were successfully treated with 180W XPS laser vaporization. Mean preoperative prostate volume was 81±28.7 ml and mean laser time was 28.2±12.5 minutes. No major complications intraoperatively or postoperatively were observed and no blood transfusions were required. Comparing to preoperative characteristics, International Prostate Symptom Score (IPSS), maximum flow rate (Qmax) and post-void residual (PVR) parameters were improved significantly and sustained during the follow-up period. At 3, 6 and 12-month follow-ups, mean urinary peak flow increased from 6.2±2.1 ml per second to 19.8±4.6, 19.4±4.7 and 19.6±4.9 ml per second, respectively. Mean International Prostate Symptom Scores decreased over time, from 28.9±4.5 to 8.2±1.6, 6.2±1.22 and 5.88±1.15 at 3, 6, 12 months, respectively. CONCLUSIONS: 180W XPS Greenlight laser vaporization is a safe and effective treatment option for patients with lower urinary tract symptoms secondary to BPH.

Office-based therapies for benign prostatic hyperplasia: a review and update.

INTRODUCTION: Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is one of the most common conditions affecting the aging man. Over the years, various treatment modalities with distinct efficacy and safety profiles have emerged in experimental and clinical use. However, only a handful have gained in popularity and stood the test of time. MATERIALS AND METHODS: We provide an update on minimally invasive treatment modalities for BPH, specifically focused on office-based procedures namely the prostatic urethral lift (UroLift) and the convective water vapor ablation therapy (Rezum). RESULTS: Both the UroLift and Rezum have demonstrated excellent efficacy and durability in relieving LUTS in the BPH patient. When compared to the gold standard TURP, these novel therapies can also be performed as an outpatient procedure under local anesthesia, which allows for decreased hospitalization, operative and catheterization times, subsequently allowing for increased cost savings. Moreover, these procedures have no discernable adverse effects on postoperative sexual function, making it a desirable treatment option for many patients. CONCLUSIONS: Both the UroLift and Rezum are minimally invasive treatment options capable of providing rapid, significant and durable relief of LUTS secondary to BPH. They demonstrate comparable efficacy to TURP with the added advantage of preserving sexual function and decreasing patient morbidity and healthcare costs.

Photoselective vaporization of the prostate: application, outcomes and safety.

INTRODUCTION: Open prostatectomy and transurethral resection of the prostate (TURP) has been the gold standard therapy for moderate to severe lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). In recent years, laser vaporization technologies have now been recognized by international guidelines as an effective treatment alternative to TURP for treating BPH. MATERIALS AND METHODS: In this contemporary review, we aim to discuss the application, outcomes and safety of photoselective vaporization of the prostate (PVP), specifically with the GreenLight laser. We also discuss the properties and evolution of the GreenLight laser as understanding the basic principles of this laser system. RESULTS: GreenLight PVP is a durable and effective alternative to TURP, especially in high-risk patients on systemic anticoagulation. Aside from providing similar efficacy and safety, the GreenLight PVP also allows for decreased hospitalization times, catheterization times and subsequently decreased healthcare costs. The latest generation laser, 180W XPS system, is found to be more cost-effective and efficacious in tissue vaporization when compared to previous laser generations. CONCLUSIONS: Laser vaporization is a safe and effective option to treating LUTS secondary to BPH. A patient-centered approach considering patient preference and preoperative parameters should be employed to determine the ideal treatment option for each individual patient.

Holmium laser enucleation of the prostate (HoLEP): a review and update.

INTRODUCTION: Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is one of the most common diseases affecting the aging man, with almost 80% of men greater than 70 affected. Historically, transurethral resection of the prostate (TURP) has been considered the historical gold standard in the treatment of LUTS due to BPH for many years, contemporary literature indicates that holmium laser enucleation of the prostate (HoLEP) has replaced TURP and open simple prostatectomy as the size independent surgical gold standard for BPH treatment. MATERIALS AND METHODS: In this review, we discuss the current techniques utilized, outcomes and safety, as well as the long term durability of results. Adverse events associated with the HoLEP procedure, both enucleation and morcellation, are covered as well. RESULTS: HoLEP has a robust body of literature supporting the technique, which demonstrates its ability to surpass other surgical BPH procedures, including TURP and open simple prostatectomy. Additionally, there is long term durability of both subjective and objective outcomes greater than 10 years associated with this procedure. One randomized trial showed specific postoperative outcome measures that were superior to TURP at 7 years of follow up, including Qmax (4.36 mL/s improvement), erectile function (2.39 points improvement on the IIEF erectile function section), and weight of prostate removed (15.7 grams greater), while other studies have shown greater reduction in postoperative PSA, lower detrusor pressure at Qmax, and more. CONCLUSIONS: Overall, HoLEP has proven to be an extremely durable and effective treatment for patients suffering from LUTS due to BPH. Both the Europeans and AUA guidelines on the surgical treatment of BPH recommend HoLEP as a size-independent treatment option for those men with moderate to severe symptoms. HoLEP is an excellent option for many patients who may not be good candidates for other procedures based on prostate size, age, or bleeding risk.

Aquablation of the prostate: a review and update.

INTRODUCTION: Invasive procedures, such as transurethral resection of the prostate (TURP), have long been the gold standard therapy for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). In recent years, newer treatment modalities have arisen, such as Aquablation, with similar efficacy and improved adverse event profiles, with particular emphasis on postoperative sexual function. MATERIALS AND METHODS: Aquablation is a new technology that utilizes machine-controlled water jets to ablate the soft tissue of the prostate as determined by the doctor. In this review, we will discuss the techniques currently being used to complete this procedure, the outcomes and safety, and finally, the long term data as well as the adverse events associated with Aquablation. RESULTS: Aquablation is rapidly effective in treating patients with LUTS due to BPH. Critically, in head to head comparison with TURP, Aquablation has equivalent objective results with much shorter resections times, and significantly less sexual side effects. Currently, the literature only reports results extending to 12 months post-procedure, and therefore long term durability of results beyond this time point remains unknown. CONCLUSIONS: Aquablation is a safe and effective option for treating LUTS secondary to BPH. Aquablation is a new surgical option that shows very promising short term results, in particular, due to its short resection time regardless of gland size and low rate of sexual side effects. This technology still requires further investigation to confirm durability and efficacy over time.

Comparison of photoselective green light laser vaporisation versus traditional transurethral resection for benign prostate hyperplasia: an updated systematic review and meta-analysis of randomised controlled trials and prospective studies.

OBJECTIVE: To assess the efficacy and safety of green-light laser photoselective vaporisation of the prostate (PVP) compared with transurethral resection of the prostate (TURP) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). DESIGN: Systematic review and meta-analysis, conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement. DATA SOURCES: PubMed, EMBASE, the Cochrane Library until October 2018. ELIGIBILITY CRITERIA: Randomised controlled trials and prospective studies comparing the safety and efficacy of PVP versus TURP for LUTS manifesting through BPH. DATA EXTRACTION AND SYNTHESIS: Perioperative parameters, complications rates and functional outcomes including treatment-related adverse events such as International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), postvoid residual (PVR), quality of life (QoL) and International Index of Erectile Function (IIEF). RESULTS: 22 publications consisting of 2665 patients were analysed. Pooled analysis revealed PVP is associated with reduced blood loss, transfusion, clot retention, TUR syndrome, capsular perforation, catheterisation time and hospitalisation, but also with a higher reintervention rate and longer intervention duration (all p<0.05). No significant difference in IPSS, Qmax, QoL, PVR or IIEF at 3, 24, 36 or 60 months was identified. There was a significant difference in QoL at 6 months (MD=-0.08; 95% CI -0.13 to -0.02; p=0.007), and IPSS (MD = -0.10; 95% CI -0.15 to -0.05; p<0.0001) and Qmax (MD=0.62; 95% CI 0.06 to 1.19; p=0.03) at 12 months, although these differences were not clinically relevant. CONCLUSION: PVP is an effective alternative, holding additional safety benefits. PVP has equivalent long-term IPSS, Qmax, QoL, PVR, IIEF efficacy and fewer complications. The main drawbacks are dysuria and reintervention, although both can be managed with non-invasive techniques. The additional shortcoming is that PVP does not acquire histological tissue examination which removes an opportunity to identify prostate cancer.

Medical evaluation and management of male and female voiding dysfunction: a review.

A significant workforce shortage of urologists available to serve the US population has been projected to occur over the next decade. Accordingly, much of the management of urologic patients will need to be assumed by other specialties and practitioners. Since primary care physicians are often first evaluate common urologic complaints, it makes sense that these physicians are in an excellent position to intervene in the management of these patients when appropriate. One of the most common complaints in urology is voiding dysfunction. The incidence of voiding dysfunction increases with age, with conservative estimates showing that over 50% of elderly patients suffer. Despite this high prevalence and its negative impact on quality of life, however, few seek or receive treatment, as many do not readily disclose these impactful yet personal symptoms. We sought to summarize the typical presentation, evaluation, assessment and therapeutic options for both male and female patients presenting with voiding dysfunction.

Toward a Scientific Nutritional Supplement Combination for Prostatism and Erectile Dysfunction I: From Known Pharmacology to Clinical Testing.

Prostatism and erectile dysfunction (ED) are highly prevalent and closely comorbid. Prescription treatments are limitingly expensive but robust in mechanisms of action (MoA). Nutritional supplements (NS) are low-cost but inadequately supported by evidence. Do any NS use robust MoA? Could their efficacy be amplified via dosing, concentration of active principles, and/or use in combination? The goal is to develop an effective NS for prostatism and ED using the MoA of prescription treatments. Literature reviews were conducted on dietary supplements for prostatism or ED and MoA of relevant drugs. The most promising NS employing these MoA were chosen. A pilot study of a prototype combination was conducted. A protocol was created for an adequate dose-response trial to test the NS combination in men with ED and prostatism. The main measures were response rates, International Prostate Symptom Score, and International Index of Erectile Function. For drugs, the MoAs best proven for prostatism and ED were nitric oxide augmentation, mild androgen inhibition, and anti-inflammatory effects. The following NS best simulate these MoA and are best supported for efficacy; for prostatism: beta sitosterol; for ED: panax ginseng, arginine, and citrulline. Pilot clinical data provided support. A plan for a formal dose-response clinical trial was approved by a central institutional review board. NS using effective MoA might suffice for prostatism and ED. Pilot testing of a combination NS with the best-supported MoA supported further development. A dose-response trial should be conducted using adequate doses of L-citrulline, beta-sitosterol, ginseng, and vitamin D3.

WATER II (80-150 mL) procedural outcomes.

OBJECTIVES: To present early safety and feasibility data from a multicentre prospective study (WATER II) of aquablation in the treatment of symptomatic men with large-volume benign prostatic hyperplasia (BPH). METHODS: Between September and December 2017, 101 men with moderate-to-severe BPH symptoms and prostate volume of 80-150 mL underwent aquablation in a prospective multicentre international clinical trial. Baseline demographics and standardized postoperative management variables were carefully recorded in a central independently monitored database. Surgeons answered analogue scale questionnaires on intra-operative technical factors and postoperative management. Adverse events up to 1 month were adjudicated by an independent clinical events committee. RESULTS: The mean (range) prostate volume was 107 (80-150) mL. The mean (range) operating time was 37 (15-97) min and aquablation resection time was 8 (3-15) min. Adequate adenoma resection was achieved with a single pass in 34 patients and with additional passes in 67 patients (mean 1.8 treatment passes), all in a single operating session. Haemostasis was achieved using either a Foley balloon catheter placed in the bladder under traction (n = 98, mean duration 18 h) or direct tamponade using a balloon inflated in the prostate fossa (n = 3, mean duration 15 h). No patient required electrocautery for haemostasis at the time of the primary procedure. The mean length of stay after the procedure was 1.6 days (range same day to 6 days). The Clavien-Dindo grade ≥2 event rate observed at 1 month was 29.7%. Bleeding complications were recorded in 10 patients (9.9%) during the index procedure hospitalization prior to discharge, and included six (5.9%) peri-operative transfusions. CONCLUSIONS: Aquablation is feasible and safe in treating men with men with large prostates (80-150 mL). The 6-month efficacy data are being accrued and will be presented in future publications (ClinicalTrials.gov number, NCT03123250).