Steven N. Gange

The Prostatic Urethral Lift for the Treatment of Lower Urinary Tract Symptoms Associated with Prostate Enlargement Due to Benign Prostatic Hyperplasia: The L.I.F.T. Study

PURPOSE We report the first multicenter randomized blinded trial of the prostatic urethral lift for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS Men at least 50 years old with AUASI (American Urological Association Symptom Index) 13 or greater, a maximum flow rate 12 ml per second or less and a prostate 30 to 80 cc were randomized 2:1 between prostatic urethral lift and sham. In the prostatic urethral lift group small permanent implants are placed within the prostate to retract encroaching lobes and open the prostatic urethra. Sham entailed rigid cystoscopy with sounds mimicking the prostatic urethral lift. The primary end point was comparison of AUASI reduction at 3 months. The prostatic urethral lift arm subjects were followed to 1 year and assessed for lower urinary tract symptoms, peak urinary flow rate, quality of life and sexual function. RESULTS A total of 206 men were randomized (prostatic urethral lift 140 vs sham 66). The prostatic urethral lift and sham AUASI was reduced by 11.1±7.67 and 5.9±7.66, respectively (p=0.003), thus meeting the primary end point. Prostatic urethral lift subjects experienced AUASI reduction from 22.1 baseline to 18.0, 11.0 and 11.1 at 2 weeks, 3 months and 12 months, respectively, p<0.001. Peak urinary flow rate increased 4.4 ml per second at 3 months and was sustained at 4.0 ml per second at 12 months, p<0.001. Adverse events were typically mild and transient. There was no occurrence of de novo ejaculatory or erectile dysfunction. CONCLUSIONS The prostatic urethral lift, reliably performed with the patient under local anesthesia, provides rapid and sustained improvement in symptoms and flow, while preserving sexual function.

Minimally Invasive Prostatic Urethral Lift: Surgical Technique and Multinational Experience

BACKGROUND Many men with benign prostatic hyperplasia (BPH) are dissatisfied with current treatment options. Although transurethral resection of the prostate (TURP) remains the gold standard, many patients seek a less invasive alternative. OBJECTIVE We describe the surgical technique and results of a novel minimally invasive implant procedure that offers symptom relief and improved voiding flow in an international series of patients. DESIGN, SETTING, AND PARTICIPANTS A total of 102 men with symptomatic BPH were consecutively treated at seven centers across five countries. Patients were evaluated up to a median follow-up of 1 yr postprocedure. Average age, prostate size, and International Prostate Symptom Score (IPSS) were 68 yr, 48 cm(3), and 23, respectively. SURGICAL PROCEDURE The prostatic urethral lift mechanically opens the prostatic urethra with UroLift implants that are placed transurethrally under cystoscopic visualization, thereby separating the encroaching prostatic lobes. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Patients were evaluated pre- and postoperatively by the IPSS, Quality-of-Life (QOL) scale, Benign Prostatic Hyperplasia Impact Index, maximum flow rate (Qmax), and adverse event reports including sexual function. RESULTS AND LIMITATIONS All procedures were completed successfully with a mean of 4.5 implants without serious adverse effects. Patients experienced symptom relief by 2 wk that was sustained to 12 mo. Mean IPSS, QOL, and Qmax improved 36%, 39%, and 38% by 2 wk, and 52%, 53%, and 51% at 12 mo (p<0.001), respectively. Adverse events were mild and transient. There were no reports of loss of antegrade ejaculation. A total of 6.5% of patients progressed to TURP without complication. Study limitations include the retrospective single-arm nature and the modest patient number. CONCLUSIONS Prostatic urethral lift has promise for BPH. It is minimally invasive, can be done under local anesthesia, does not appear to cause retrograde ejaculation, and improves symptoms and voiding flow. This study corroborates prior published results. Larger series with randomisation, comparator treatments, and longer follow-up are underway.

Treatment of LUTS secondary to BPH while preserving sexual function: randomized controlled study of prostatic urethral lift.

INTRODUCTION We analyzed data obtained from a randomized controlled blinded study of the prostatic urethral lift (PUL) to evaluate the sexual side effects of this novel treatment. AIMS We sought to determine whether PUL, when conducted in a randomized study, significantly improved lower urinary tract symptoms (LUTS) and urinary flow rate while preserving sexual function. METHODS Men ≥50 years with prostates 30-80 cc, International Prostate Symptom Score (IPSS) >12, and peak urinary flow rate (Qmax) ≤12 ml/s were randomized 2:1 between PUL and sham. Sexual activity was not an inclusion criterion. In PUL, permanent transprostatic implants are placed to retract encroaching lateral lobes and open the prostatic fossa. Sham entailed rigid cystoscopy with sounds to mimic PUL and a blinding screen. MAIN OUTCOME MEASURES Blinded groups were compared at 3 months and active arm then followed to 12 months for LUTS with IPSS and for sexual function with sexual health inventory for men (SHIM) and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). Subjects were censored from primary sexual function analysis if they had baseline SHIM < 5 at enrollment. Secondary stratified analysis by erectile dysfunction (ED) severity was conducted. RESULTS There was no evidence of degradation in erectile or ejaculatory function after PUL. SHIM and MSHQ-EjD scores were not different from control at 3 months but were modestly improved and statistically different from baseline at 1 year. Ejaculatory bother score was most improved with a 40% improvement over baseline. Twelve-month SHIM was significantly improved from baseline for men entering the study with severe ED, P = 0.016. IPSS and Qmax were significantly superior to both control at 3 months and baseline at 1 year. There was no instance of de novo sustained anejaculation or ED over the course of the study. CONCLUSIONS The PUL improves LUTS and urinary flow while preserving erectile and ejaculatory function.

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

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.

Durability of the Prostatic Urethral Lift: 2-Year Results of the L.I.F.T. Study

Introduction: For a therapy to become an important part of a provider armamentarium it must be safer or better than existing therapies and be durable. The prostatic urethral lift offers rapid improvement in lower urinary tract symptoms associated with benign prostatic hyperplasia with minimal side effects. We report 2‐year results of a multicenter, randomized, blinded trial of the prostatic urethral lift. Methods: A total of 206 men 50 years old or older with an AUA‐SI of 13 or greater, a peak flow rate of 12 ml per second or less and a 30 to 80 cc prostate were randomized 2:1 between the prostatic urethral lift and sham treatment. The prostatic urethral lift is performed by placing permanent transprostatic implants to lift apart the prostate lobes and reduce urethral obstruction. Sham treatment entailed rigid cystoscopy, a blinding screen and sounds that mimicked those of the prostatic urethral lift procedure. Patients were assessed for lower urinary tract symptoms, peak flow rate, quality of life and sexual function. Results: The prostatic urethral lift reduced the AUA‐SI 88% more than sham treatment (−11.1 vs −5.9, p = 0.003). Patients with the prostatic urethral lift experienced an AUA‐SI reduction from 22.1 at baseline to 18.0 (−17%), 11.1 (−50%), 11.4 (−48%) and 12.5 (−42%) at 2 weeks, 3 months, and 1 and 2 years, respectively (p <0.0001). The peak flow rate was increased 4.2 ml per second at 3 months and 2 years (p <0.0001). By 2 years only 7.5% of patients required additional intervention for lower urinary tract symptoms. Adverse events were typically mild and transient. Encrustation did not develop on implants properly placed in the prostate. There was no occurrence of de novo sustained ejaculatory or erectile dysfunction. Conclusions: The prostatic urethral lift preserves sexual function and provides rapid improvement in symptoms, flow and quality of life that are sustained to 2 years.Abbreviations and Acronyms: AUA‐SI: American Urological Association Symptom Index; BPH: benign prostatic hyperplasia; BPHII: BPH Impact Index; FDA: Food and Drug Administration; GEE: general estimating equation; L.I.F.T.: Luminal Improvement Following Prostatic Tissue approximation for the treatment of LUTS secondary to BPH; LUTS: lower urinary tract symptoms; MSHQ‐EjD: Male Sexual Health Questionnaire for Ejaculatory Dysfunction; PUL: prostatic urethral lift; Qmax: peak urinary flow rate; QOL: quality of life; SHIM: Sexual Health Inventory for Men; TURP: transurethral prostate resection.

New and Emerging Technologies in Treatment of Lower Urinary Tract Symptoms From Benign Prostatic Hyperplasia

INTRODUCTION Lower urinary tract symptoms (LUTS) from bladder outlet obstruction from benign prostatic hyperplasia (BPH) occur in a large percentage of urologic patients. Treatment of this condition with medical and surgical therapy provides symptom relief but has serious adverse effects and causes sexual dysfunction. New technologies to treat BPH-associated LUTS aim to effectively treat urinary symptoms and minimize side effects and sexual dysfunction. AIM To review the efficacy of new and emerging therapies for treatment of LUTS from BPH. METHODS A literature search was performed to identify therapies for LUTS from BPH with early outcomes data within the past 5 years. MAIN OUTCOME MEASURES Improvement in International Prostate Symptom Score (IPSS) and effect on sexual functions such as erectile and ejaculatory functions as measured on the International Index of Erectile Function and the Male Sexual Health Questionnaire. RESULTS Technologies introduced within the past 5 years include techniques using intraprostatic injectables, mechanical devices, and prostatic tissue ablation. Most technologies remain in the development phase and have only phase I and II studies available that show promising alleviation of urinary symptoms. Injectables have not typically surpassed placebo or sham effects, although special cohorts could be exceptions. Thus far, convective water vapor ablation therapy and prostatic urethral lift have shown the most promise, with short- and medium-term data available on phase III studies demonstrating significant improvement in IPSS with minimal impact on sexual function. Many of these technologies are limited in their potential treatment population by prostate size and conformation, whereas other therapies might be more generalizable. CONCLUSION Many new technologies aim to treat LUTS from BPH and minimize sexual side effects. Most therapies remain experimental, although prostatic urethral lift and water vapor ablation therapy have been brought to market and show promise. Long-term durability of symptom relief remains to be demonstrated. Gupta NK, Gange SN, McVary KT. New and Emerging Technologies in Treatment of Lower Urinary Tract Symptoms From Benign Prostatic Hyperplasia. Sex Med Rev 2018;XX:XXX-XXX.

Response and Rebuttal to Editorial Commentary on "Erectile and Ejaculatory Function Preserved With Convective Water Vapor Energy Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Randomized Controlled Study"

Thank you for the opportunity to respond to Dr Corona’s comments. Parsimoniously stated, lower urinary tract symptoms (LUTS) and the treatments impact sexual function. The challenge in advancing the medical and surgical care of men with LUTS is to maximize the impact on the bothersome symptoms while avoiding the undesirable effects on erectile and ejaculatory function. Excitingly, this new technology offers that possibility. Durability of the therapeutic response in men with LUTS and its impact is the next important issue and future reports will be forthcoming. We agree with Dr Corona that the need for comparative trials of the convective vapor technique with standard surgical approaches. These types of comparisons will undoubtedly be forthcoming, but clearly Dr Corona will agree that in any investigatory endeavor one must start at the beginning. This beginning was a success and lays the ground for confirmatory studies as well as those suggested above. Dr Corona wonders if the randomized controlled trial (RCT) accounted and controlled for the proper confounding variables impacting men with LUTS that we have previously published. To avoid the plague of self-citation we will not belabor these publications here. Concerning the possibility that these risk factors may confound the measurement of sexual function in this report, in our view the randomization process controls for these putative confounders unless one believes that the controls or the treatment groups are somehow unequally weighted in respective cohorts. Our analysis suggest that such bias do not exist. Contrary to cross-sectional and single cohort studies, one advantage of the blinded RCT design is the inherent protection against such unaccounted variables.

Adult UrologyVoiding DysfunctionThe Prostatic Urethral Lift for the Treatment of Lower Urinary Tract Symptoms Associated with Prostate Enlargement Due to Benign Prostatic Hyperplasia: The L.I.F.T. Study

PURPOSE We report the first multicenter randomized blinded trial of the prostatic urethral lift for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS Men at least 50 years old with AUASI (American Urological Association Symptom Index) 13 or greater, a maximum flow rate 12 ml per second or less and a prostate 30 to 80 cc were randomized 2:1 between prostatic urethral lift and sham. In the prostatic urethral lift group small permanent implants are placed within the prostate to retract encroaching lobes and open the prostatic urethra. Sham entailed rigid cystoscopy with sounds mimicking the prostatic urethral lift. The primary end point was comparison of AUASI reduction at 3 months. The prostatic urethral lift arm subjects were followed to 1 year and assessed for lower urinary tract symptoms, peak urinary flow rate, quality of life and sexual function. RESULTS A total of 206 men were randomized (prostatic urethral lift 140 vs sham 66). The prostatic urethral lift and sham AUASI was reduced by 11.1±7.67 and 5.9±7.66, respectively (p=0.003), thus meeting the primary end point. Prostatic urethral lift subjects experienced AUASI reduction from 22.1 baseline to 18.0, 11.0 and 11.1 at 2 weeks, 3 months and 12 months, respectively, p<0.001. Peak urinary flow rate increased 4.4 ml per second at 3 months and was sustained at 4.0 ml per second at 12 months, p<0.001. Adverse events were typically mild and transient. There was no occurrence of de novo ejaculatory or erectile dysfunction. CONCLUSIONS The prostatic urethral lift, reliably performed with the patient under local anesthesia, provides rapid and sustained improvement in symptoms and flow, while preserving sexual function.