Prostatic Urethral Lift Procedure Research Articles

Initial experience with prostatic urethral lift versus enucleation of the prostate: a retrospective comparative study

BackgroundThis study aimed to assess initial results and patient characteristics of prostatic urethral lift (PUL) compared with those of bipolar transurethral enucleation of the prostate (TUEB) in the treatment of benign prostatic hyperplasia (BPH) in older patients.MethodsThis retrospective study was conducted at a single institution and involved 25 consecutive patients with BPH who underwent PUL between April 2022 and May 2023. Patient characteristics, operative details, and pre- and postoperative symptom scores were evaluated. The results were compared with those of a previously reported TUEB group (n = 55).ResultsThe mean age of the patients in the PUL group was 74.6 years, and the mean prostate volume was 47.5 ml. The PUL procedure significantly improved urinary symptoms, particularly incomplete emptying (p = 0.041), intermittency (p = 0.005), and weak stream (p = 0.001). The PUL group had higher comorbidity scores (p = 0.048) and included older patients (p = 0.002) than the TUEB group. TUEB showed better improvements in some symptoms and maximum flow rate (p = 0.01) than PUL; however, PUL had a shorter operative time and fewer complications than TUEB (p < 0.001).ConclusionThe initial results demonstrate the efficacy and safety of PUL in older patients with BPH. Despite TUEB showing better outcomes in certain aspects than PUL, PUL offers advantages such as shorter operative time and fewer complications. Therefore, PUL can be considered a viable option for high-risk older patients with BPH.

Long-Term Effectiveness of a Nonsurgical BPH Treatment System in Prostate Radiation Patients with Medication-Refractory Lower Urinary Tract Symptoms.

To evaluate the long-term outcomes and toxicity of a nonsurgical prostatic urethral lift system in patients with prior prostate cancer radiation therapy (RT). From 2018 to 2020, nineteen patients with a history of prior prostate RT underwent a nonsurgical prostatic urethral lift (PUL) procedure for lower urinary track symptoms (LUTS) refractory to alpha blocker medications. Prostate cancer RT was completed a median of 17.8 months (IQR 13.4-27.4) prior to PUL procedure. All patients were assessed with IPSS/quality of life (QOL) scores and urinary post void residual (PVR) ultrasound before and after PUL. Patients were also assessed for ability to discontinue alpha blockade medications for their LUTS and any post PUL toxicity based on CTCAE v5.0 criteria. All patients underwent successful placement of the PUL implants. Median pre-PUL IPSS score was 20 (IOR 17.5-22.5) and the median prostate volume was 41cc (IQR 33-49). Median follow up was 22 months (IQR 5-30). The average improvement in IPSS score was 8.5 points (IRQ 5.5-11) at 3 months and 7.5 points (IQR 6-10) at last follow-up. Two patients (10%) initially had improvement in IPSS score at 3 months with subsequent significant increase in IPSS (>5 points) at last follow-up. Overall, there was minimal change in reported QOL scores (median 0, IQR 0-1.75). The average reduction in PVR was 90cc. The percentage of patients able to discontinue alpha blockade at last follow-up was 68%. There was no grade 3 or higher GU toxicity in either group. Use of a nonsurgical prostatic urethral lift system in patients with prior prostate RT refractory to alpha blocker medications results in significant long-term improvement of LUTS after radiation therapy for the majority of patients with minimal toxicity.

Benign prostatic hyperplasia surgical re-treatment after prostatic urethral lift: A narrative review.

Prostatic urethral lift (PUL) accounts for approximately one-quarter of all surgical benign prostatic hyperplasia (BPH) procedures performed in the U.S.1 Within five years of a patient's PUL procedure, approximately 1/7 patients will require surgical BPH re-treatment.2 We aimed to highlight the evidence of surgical BPH re-treatment modalities after PUL, with a focus on safety, short-term efficacy, durability, and relative costs. A literature review was performed using PubMed, and an exhaustive review of miscellaneous online resources was completed. The search was limited to English, human studies. Citations of relevant studies were reviewed. No study has examined the efficacy, safety, or durability of transurethral resection of the prostate (TURP) or repeat PUL in the post-PUL setting. Recently, groups have examined laser enucleation (n=81), water vapor thermal therapy (WVTT) (n=5), robotic simple prostatectomy (SP) (n=2), and prostatic artery embolization (PAE) (n=1) in the post-PUL setting. Holmium enucleation of the prostate (HoLEP) after PUL appears to be safe and has similar functional outcomes to HoLEP controls. Other treatment modalities examined appear safe but have limited efficacy evidence supporting their use. Photo-selective vaporization of the prostate (PVP) and robotic waterjet treatment (RWT) have no safety or efficacy studies to support their use in the post-PUL setting. Despite increasing numbers of patients expected to require surgical re-treatment after PUL in North America, there is currently limited evidence and a lack of recommendations guiding the evaluation and management of these patients. HoLEP is associated with the strongest evidence to support its use in the post-PUL setting.

A cost-effectiveness analysis of pharmacotherapy versus prostatic urethral lift as initial therapy for patients with moderate benign prostatic hyperplasia

ABSTRACT Aim The objective of this study was to evaluate the cost-effectiveness of an upfront minimally invasive surgical procedure, the prostatic urethral lift (PUL), as an initial treatment for patients with moderate benign prostatic hyperplasia (BPH), against current first-line pharmacotherapy with combination medical therapy. Method A micro-simulation model was developed using TreeAge Pro to compare two treatment strategies – initial treatment with combination medical therapy (alpha-blocker + 5-ARI) versus an upfront prostatic urethral lift procedure. The impact on disease progression, costs, and quality-adjusted life-years (QALYs) was analyzed. A Markov model and probabilistic sensitivity analysis were used to estimate the costs and effects of the different strategies. The cost-effectiveness of the strategies at different willingness-to-pay (WTP) thresholds was then examined. Results Incremental costs (versus no prostatic urethral lift) were S$13,600 (1 year) and S$8,700 (5 years). Incremental QALYs were 0.07 (1 year) and 0.22 (5 years). An upfront PUL procedure was more expensive but also more effective than pharmacotherapy, with an incremental cost per QALY gain of approximately S$39,400. It is a cost-effective treatment option at the willingness-to-pay threshold of S$50,000. Conclusion Prostatic urethral lift is a cost-effective initial treatment option for men with moderate symptoms of benign prostatic hyperplasia.

MP33-13 IMPACT OF PROSTATIC URETHRAL LIFT DEVICE ON PROSTATE MR IMAGE QUALITY

You have accessJournal of UrologyCME1 May 2022MP33-13 IMPACT OF PROSTATIC URETHRAL LIFT DEVICE ON PROSTATE MR IMAGE QUALITY Tarik Benidir, Ryan Ward, Justin Ream, Ethan Austhof, Eric Klein, Ismail Turkbey, and Andrei Purysko Tarik BenidirTarik Benidir More articles by this author , Ryan WardRyan Ward More articles by this author , Justin ReamJustin Ream More articles by this author , Ethan AusthofEthan Austhof More articles by this author , Eric KleinEric Klein More articles by this author , Ismail TurkbeyIsmail Turkbey More articles by this author , and Andrei PuryskoAndrei Purysko More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002587.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Prostatic urethral lift (PUL) using the UroLift device is a non-pharmacological treatment option for patients with symptomatic benign prostatic hyperplasia. Patients with this device can safely undergo prostate MRI, but the influence of this device on prostate MR image quality has not been assessed. The aim of this study is to evaluate prostate MR image quality in patients with UroLift. METHODS: This retrospective study included 43 adult men (mean age 65.2yrs; mean PSA 5.86 ng/mL) with UroLift who underwent prostate MRI at two institutions. Images from one of the institutions (n=36) were reviewed and scored based on severity of artifacts caused by the device on T2-weighted (T2W), Diffusion weighted images (DWI) and apparent diffusion coefficient (ADC) maps in the peripheral zone (PZ) and transition zone (TZ) using a 5-point scale (1 – no impact on interpretation; 5 – non-diagnostic). Total prostate gland volumes and the prostate volumes obscured by the artifacts on T2W, ADC maps and dynamic contrast enhanced (DCE) images were measured. The means of the scores assigned for severity of artifacts and percentage of gland volumes affected by the artifacts were calculated. T-test was used to compare differences in image quality scores. RESULTS: The average prostate volume was 59.1 cc (IQR: 42.7-79). The mean image quality scores were worse for DWI/ADC than T2W both in the PZ (1.7 vs 1, p=0.0001) and in the TZ (3.2 vs 1.7 p=0.001). Worse scores were observed on DWI/ADC in the TZ at the base and mid gland compared to the apex (means scores 3.8, 3.5 and 2.5, respectively; p <0.05). The mean prostate volumes obscured by artifact on T2W, ADC map and DCE were 3.3 cc (IQR:2.0-4.5), 16.2 cc (IQR:10.5-21.6) and 6.4 cc (IQR:3.4-7.3). The mean percentage of prostate volume obscured by artifacts on T2W, ADC map and DCE were 0.06 (95% CI 0.05 to 0.07), 0.3 (95% CI 0.25 to 0.35) and 0.11 (95% CI 0.08 to 0.14), respectively. CONCLUSIONS: UroLift causes artifacts that can affect prostate MRI interpretation, with greater impact in the TZ and on DWI/ADC maps (Figure 1). Men considering undergoing PUL procedure should be counseled on the negative impact of this device on quality of prostate MRI. Source of Funding: Cleveland Clinic imaging department © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e575 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Tarik Benidir More articles by this author Ryan Ward More articles by this author Justin Ream More articles by this author Ethan Austhof More articles by this author Eric Klein More articles by this author Ismail Turkbey More articles by this author Andrei Purysko More articles by this author Expand All Advertisement PDF DownloadLoading ...

Is Prostate Urethral Lift Effective in Patients with Multiple Comorbidities?

A prostatic urethral lift (PUL) can be performed under local anesthesia in patients normally at high risk for general anesthesia due to multiple comorbidities. However, the clinical efficacy of PULs in patients with multiple comorbidities remains unknown. Therefore, in this this study, we aimed to evaluate the clinical efficacy of the PUL in patients with a high number of comorbidities by comparing its clinical efficacy in these patients with that in healthy individuals. We performed a retrospective observational cohort study, in which patients who underwent a PUL between December 2016 and January 2019 at a single tertiary care center were categorized into two groups: healthy individuals who wanted to preserve sexual function (Group 1) and patients with a high number of comorbidities who were at high risk for general anesthesia, based on an American Society of Anesthesiologists (ASA) score of ≥3 (Group 2). The International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), and post-void residual urine (PVR) were obtained preoperatively and compared throughout the 2-year follow-up. A total of 66 patients were enrolled, of whom 36 patients were included in Group 1 and 30 in Group 2. In Group 1, IPSS, IPSS quality of life (QoL), and Qmax significantly improved and were then maintained during follow-up, whereas, in Group 2, improvements in these parameters were not maintained during follow-up, except for IPSS QoL. Eleven patients (36%) in Group 2 required additional treatment for the recurrence of lower urinary tract symptoms. In conclusion, patients with a high number of comorbidities had a low therapeutic effect after PUL, suggesting a high rate of treatment failure. Therefore, comorbidity status should be considered when evaluating the potential benefits of the PUL procedure during preoperative counseling.

Improvement of Medication-Refractory Lower Urinary Tract Symptoms After Prostate Radiation Therapy Using a Prostatic Urethral Lift System

<h3>Purpose/Objective(s)</h3> To evaluate the success and toxicity of a nonsurgical prostatic urethral lift system in patients with lower urinary tract symptoms (LUTS) with and without prior prostate cancer radiation therapy. <h3>Materials/Methods</h3> From 2018 to 2020, thirty-eight patients underwent a nonsurgical prostatic urethral lift (PUL) procedure for LUTS refractory to alpha blocker medications. All patients had cystoscopic confirmation of lateral lobe obstruction. Nineteen patients underwent prior radiation therapy (RT) for prostate cancer completed an average of 15.3 months (range 3-28) prior to PUL procedure. Nineteen patients had no prior prostate cancer treatment. All patients were assessed with IPSS/quality of life (QOL) scores and urinary post void residual (PVR) ultrasound before and after PUL. Patients were also assessed for ability to discontinue alpha blocker medications for their LUTS and any post PUL toxicity based on CTCAE v5.0 criteria. Statistical comparisons before and after the PUL procedure were made with Wilcoxon signed rank test with <i>P</i> < 0.05 considered significant. <h3>Results</h3> All patients underwent successful placement of the PUL implants. Median follow up was 10 months (range 3-30). Median prostate volume was 45cc (range 20-85) for no-RT group and 41cc (range 24-80) for RT group. Median pre-PUL IPSS score was 17 (range 9-33) in the no-RT and 20 (range 11-34) in the RT groups. At last follow up, the average improvement in IPSS score was 9 points for all patients (95% CI 7-11, <i>P</i> < 0.001), 8 points for the RT patients (95% CI 5-12, <i>P</i> < 0.001) and 9 points for the no-RT patients (95% CI 7-12, <i>P</i> < 0.001). QOL improved by 1.1 points on average (95% CI 0.6-1.6, <i>P</i> < 0.001) for all patients, with similar improvement for both the RT (0.9, 95% CI 0.1-1.9. <i>P</i> = 0.09) and the no-RT (1.3, 95% CI 0.7-1.8, <i>P</i> < 0.001) patients. The average reduction in PVR was 93cc (95% CI 56-130, <i>P</i> < 0.001) for all patients, similar for both RT (90cc, 95% CI 42-138, <i>P</i> = 0.001) and no-RT (96cc, 95% CI 37-155, <i>P</i> < 0.001) patients. The percentage of patients able to discontinue alpha blockade at last follow-up was 68% for the RT patients and 74% for the no-RT patients. There was no grade 3 or higher GU toxicity in either group. <h3>Conclusion</h3> Use of a nonsurgical prostatic urethral lift system, results in significant improvement of LUTS after radiation therapy without complications, similar to patients without prior prostate radiation therapy.

Urodynamic Effects of Prostatic Urethral Lift Procedure for Male Voiding Lower Urinary Tract Symptoms.

Aims: Primary objective is to investigate whether prostatic urethral lift (PUL) results in an improvement of urodynamic parameters that define bladder outlet obstruction (urethral resistance algorithm [urethral resistance factor (URA)], Schäfer grade, detrusor pressure at maximum flow [PdetQmax], and detrusor pressure at bladder opening [PdetOpen]). Materials and Methods: Twenty patients (main inclusion criteria: ≥50 years of age, benign prostatic obstruction (BPO), international prostate symptom score (IPSS) ≥13, prostate volume ≤60 mL, and no middle prostate lobe) were enrolled in the study and a PUL was performed. Patients underwent urodynamic investigation and filled out the IPSS and quality of life (QoL) before and after PUL. A paired t-test was used to analyze the results. Results: The mean age was 68 years (range 55-79), mean prostate volume (TRUS) was 45 mL (range 20-59), and mean prostate-specific antigen was 2.0 μg/L (0.2-4.4). IPSS of the 16 patients reduced significantly (from 22.20 to 14.47, p = 0.000). Qmax during pressure flow study improved significantly (from 4.5 to 7.2 mL/s, p = 0.001), no significant difference was found in Qmax during free uroflowmetry. There was no significant difference found in postvoiding residual. URA decreased significantly post-treatment (from 52 to 37 cmH2O, p = 0.000). The Schäfer obstruction plot decreased significantly (from 3.5 to 2.6, p = 0.022). Seven patients underwent Greenlight Laser Vaporization of the prostate after the PUL attributable to unsatisfactory results. Conclusions: PUL has desobstructive effects, but they seem clinically modest. The procedure improves urodynamic parameters as well as QoL in males with lower urinary tract symptoms based on BPO. However, the mechanism how PUL leads to a remarkable symptom relief remains unclear and cannot be explained by the desobstructive mechanisms we observed.

Prostate Artery Embolization Used in the Management of Transfusion-Dependent Hematuria After Prostatic Urethral Lift Procedure in a Patient with Thrombocytopenia: A Case Report.

Background: The prostatic urethral lift (PUL) procedure is a novel therapeutic method to treat lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). Gross hematuria after this procedure has been reported to be mild and transient. This report highlights a case of refractory transfusion-dependent hematuria after the PUL procedure in addition to its management with selective prostatic arterial embolization (PAE). Case Presentation: A 78-year-old Caucasian man with a history of myelodysplastic syndrome, thrombocytopenia, and intermittent urinary retention secondary to BPH underwent a PUL procedure. Before the procedure he received a platelet transfusion making his platelet count 58,000/μL. The day after the procedure he was admitted to a hospital for gross hematuria with clot retention. He was started on continuous bladder irrigation and taken to the operating room for clot evacuation and fulguration of prostate. His thrombocytopenia and anemia were managed with transfusions. He was treated with desmopressin, aminocaproic acid, and intravesical 1% alum without improvement. He returned to the operating room for clot evacuation in addition to photoselective vaporization of the prostate laser ablation of the prostatic fossa. He eventually required a total of four transurethral fulgurations without improvement in transfusion-dependent hematuria. Ultimately, resolution of the hematuria was achieved through bilateral PAE with Embosphere® Microspheres performed by interventional radiology. He was discharged home 2 days after the embolization procedure without recurrence of hematuria or urinary retention at a 6-month follow-up visit. Conclusion: The PUL procedure has been shown to be an effective alternative to more invasive surgical options for LUTS caused by BPH. Despite careful consideration in an attempt to alleviate urinary retention, PUL still resulted in significant bleeding in this patient with thrombocytopenia. This is the first report to highlight the use of bilateral PAE as a method for achieving control of severe refractory hematuria after PUL.

Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study

Evidence indicating Prostatic Urethral Lift (PUL) delivers significant improvement in symptomatic BPH with low morbidity is based on subjects with lateral lobe (LL) enlargement only. MedLift was an FDA IDE extension of the L.I.F.T. randomized study designed to examine safety and efficacy of PUL for treatment of obstructive middle lobes (OML). Inclusion criteria for this non-randomized cohort were identical to the L.I.F.T. randomized study, except for requiring an OML: ≥ 50 years of age, IPSS ≥ 13, and Qmax ≤ 12 ml/s. Primary endpoint analysis quantified improvement in IPSS over baseline and rate of post-procedure serious complications. Quantification of symptom relief, quality of life, flow rate, and sexual function occurred through 12 months. Outcomes were compared to historical L.I.F.T LL results and were combined to demonstrate the full effectiveness of PUL. Of the 71 screened subjects, 45 were enrolled. At 1, 3, 6, and 12 months, mean IPSS improved from baseline at least 13.5 points (p < 0.0001). Quality of life and BPHII were similarly improved (>60% and >70%, respectively at 3, 6, and 12 months, p < 0.0001). Mean Qmax improvement ranged from 90 to 129% (p < 0.0001). At 1 month, 86% (CI 73–94%) reported ≥70 on the Quality of Recovery scale, 80% (CI 66–89%) reported being “much” or “very much better,” and 89% (CI 76–95%) would recommend the procedure. Compared to LL subjects, OML subjects’ symptoms improved at least as much at every time point (OML range 13.5–15.9, LL range 9.9–11.1, p ≤ 0.01). On combining OML with LL data, >70% (range CI 63–81%) of subjects demonstrated ≥ 8 point improvement in IPSS through 12 months. Analysis of the combined dataset indicates ≥ 40% (CI 30–51%) of sexually active men improved the minimal clinically important difference in erectile function through 12 months. Prostates, including those with middle lobe obstruction, can be treated with the PUL procedure safely and effectively.

Minimally invasive prostatic urethral lift (PUL) efficacious in TURP candidates: a multicenter German evaluation after 2\xa0years

IntroductionSuccessful outcomes have been reported for the treatment of lower urinary tract symptoms (LUTS) with the prostatic urethral lift (PUL) in a number of clinical investigations. Our aim was to investigate PUL outcomes in patients treated in a day-to-day clinical setting without the rigid exclusion criteria of clinical studies.Materials and methodsWe investigated the outcome of the PUL procedure at five German departments during the initial period when PUL was approved for the clinic (10/2012–06/2014). All candidates for transurethral resection of the prostate (TURP) received PUL information and were given the choice of procedures. The only exclusion criterion was an obstructive median lobe. No patients were excluded because of high post-void residual volume (PVR), prostate size, retention history or LUTS oral therapy. Maximum urinary flow (Qmax), PVR, International Prostate Symptom Score (IPSS) and Quality of Life (QOL) were assessed at baseline, 1, 6, 12, and 24 months after surgery.ResultsOf 212 TURP candidates, 86 choose PUL. A mean of 3.8 (2–7) UroLift implants were implanted in patients of 38–85 years with a prostate size of 17–111 ml over 57 (42–90) min under general or local anesthesia. Thirty-eight (38.4%) patients had severe BPH obstruction and would have been denied PUL utilizing previously reported study criteria. Within 1 month 74 (86%) reported substantial symptom relief with significant improvements in Qmax, PVR, IPSS, and QOL (p < 0.001) that was maintained within the follow-up. Sexual function including ejaculation was unchanged or improved. No Clavien–Dindo Grad ≥ 2 was reported postoperatively. Eleven (12.8%) patients were retreated over 2 years. Twelve (86%) of 14 patients presenting with chronic urinary retention were catheter free at last follow-up.ConclusionPUL is a promising surgical technique that may alleviate LUTS, even in patients with severe obstruction.

Prostatic Urethral Lift: Does Size Matter?

To assess if prostatic urethral lift (PUL) can be as effective on larger prostates. PUL is an endoscopic device that retracts prostatic tissue to relieve benign prostatic hypertrophy (BPH) obstruction. In 2013, PUL was approved for patients with a prostate size of <80 g and no median lobes. The approval was primarily based on the L.I.F.T. study, which only evaluated patients with prostates between 30 and 80 g in size. Seventy-four patients underwent PUL between April 2, 2014, and December 2, 2015, for BPH management. Fifty-one patients were in the <80 g prostate group (median: 46 g, range: 20-78 g) and 23 in the >80 g prostate group (median: 112 g, range: 81-254 g). Student t-tests and Fisher's exact tests were used to compare continuous and categorical variables. p-Value of <0.05 was considered statistically significant. Median time between PUL and follow-up AUA symptom score (AUASS) was 144 days. A difference between the numbers of PUL implants used was seen. A significant improvement in AUASSs was seen in both groups following the procedure. There was no significant difference in age, AUASS before or after the procedure, or need for an additional outlet procedure between the two groups. Early experience finds that a sufficient number of men with larger prostates appear to benefit from PUL. Patients with >80 g prostate size were more likely to have a median lobe and may benefit from resection of the median lobe at time of the PUL. Long-term follow-up is needed to evaluate the durability of the PUL procedure.

PUK20 - Comparison of Costs Associated with Turp and Prostatic Urethral Lift for Benign Prostatic Hyperplasia

To compare outcomes and costs associated with treatment of benign prostatic hyperplasia (BPH) by monopolar or bipolar transurethral resection of the prostate (TURP) or prostatic urethral lift (PUL). We searched the literature for reports on PUL (from 2010 onwards) and TURP, and were allowed access to the National Health Service Hospital Episode Statistics (HES) database (Copyright NHS Digital 2018) and The Health Improvement Network (THIN) to search at the record level for hospitalisation and treatment rates for TURP in England, from January 2009/10 onwards. In 2016/17, 18,362 TURP procedures were performed. The mean procedure cost was £2,869 (IQR £2,422–3,138; total ~£43 million) and the average hospital stay was 2.7 days. Complications of TURP include ejaculatory dysfunction (≥65%), erectile dysfunction (10%), urethral stricture (4%), infection (4%), bleeding requiring transfusion (2%), and urinary incontinence (2%). Around 20% of patients restart drug therapy for lower urinary tract symptoms (LUTS) within 3 years. Among all recipients of TURP for BPH in 2009/10, cumulative HES data to 2014/15 showed 70,000 post-procedure hospital spells, incurring payer costs of £109 million. The mean PUL procedure cost in 2015/16 was £2,405. Typically, no hospital stay or catheterisation are required. Most adverse events (mainly dysuria, discomfort, urgency, and haematuria) are mild to moderate and resolve in 2–4 weeks without hospital treatment. Erectile and ejaculatory function are preserved. LUTS improvement is comparable to that for TURP but is more rapid and remains stable at 5 years. If we assume, based on this complication profile, that the £109 million spending on complications could be halved and that 50% of TURP recipients would be candidates for PUL, we estimate a saving of £27 million per year. PUL could reduce complications, improve quality of life, and substantially reduce costs currently associated with current standard TURP practice.

Holmium Laser Enucleation of the Prostate After Prostatic Urethral Lift Surgery: Feasibility and Technical Considerations from a Multi-Institutional Case Series.

Ten percent of patients undergoing prostatic urethral lift (PUL) require repeat surgical treatment within 3 years. We describe the feasibility and considerations of performing holmium laser enucleation of the prostate (HoLEP) as a salvage therapy after previous PUL. Men who had undergone HoLEP after PUL were retrospectively identified from three institutions with surgeons experienced in HoLEP. Subjects were characterized by age, time from PUL procedure (months) to HoLEP surgery, indication for retreatment, and pre-operative prostate volume by ultrasound. Outcomes of interest included enucleation time, morcellation time, morcellator type, weight of tissue resected, and Clavien complications. We also summarize findings related to the location of PUL device implants, and the effect of the implants on the enucleation and morcellation portions of the procedure. From December 15, 2015 to October 31, 2016, seven men aged 51-78 years underwent HoLEP at a median of 8.6 months (range 3-18) after PUL. The median prostate volume by transrectal ultrasound was 80 cm3 (range 56-160 cm3). For the 7 patients, 6 out of the 22 device implants were found in aberrant locations. Auxiliary maneuvers were required in five cases. Morcellation devices tended to jam with each implant, requiring a pause for withdrawal of the morcellator and manual removal from the blade or requiring grasper retrieval of device components. There were no Clavien complications. HoLEP can be performed safely and effectively post-PUL; however, device implants may be found in areas other than the intended location, and morcellation of the adenoma tissue is complicated by metallic implants of the PUL device.

PD27-01 5 YEAR PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY RESULTS ON THE MINIMALLY INVASIVE PROSTATIC URETHRAL LIFT (PUL)

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology IV1 Apr 2017PD27-01 5 YEAR PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY RESULTS ON THE MINIMALLY INVASIVE PROSTATIC URETHRAL LIFT (PUL) Claus Roehrborn, Steven Gange, Neal Shore, Jonathan Giddens, Damien Bolton, Barrett Cowan, Anthony Cantwell, Kevin McVary, Peter Chin, Alexis Te, Shahram Gholami, Prem Rashid, William Moselely, Ronald Tutrone, Sheldon Freedman, Peter Incze, K. Scott Coffield, Fernando Borges, and Daniel Rukstalis Claus RoehrbornClaus Roehrborn More articles by this author , Steven GangeSteven Gange More articles by this author , Neal ShoreNeal Shore More articles by this author , Jonathan GiddensJonathan Giddens More articles by this author , Damien BoltonDamien Bolton More articles by this author , Barrett CowanBarrett Cowan More articles by this author , Anthony CantwellAnthony Cantwell More articles by this author , Kevin McVaryKevin McVary More articles by this author , Peter ChinPeter Chin More articles by this author , Alexis TeAlexis Te More articles by this author , Shahram GholamiShahram Gholami More articles by this author , Prem RashidPrem Rashid More articles by this author , William MoselelyWilliam Moselely More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , Sheldon FreedmanSheldon Freedman More articles by this author , Peter InczePeter Incze More articles by this author , K. Scott CoffieldK. Scott Coffield More articles by this author , Fernando BorgesFernando Borges More articles by this author , and Daniel RukstalisDaniel Rukstalis More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.1222AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The Prostatic Urethral Lift (PUL) has been previously shown to rapidly and durably address lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia with minimal side effects. The 5 year concluding data from the largest multi-center, randomized, controlled, study on PUL is herein presented. METHODS PUL procedure involves placing permanent UroLift® implants into the lateral lobes of the prostate to enlarge the urethral lumen. Enrollment criteria included age = 50 years, IPSS (International Prostate Symptom Score) = 13, peak flow rate = 12 ml/s, and prostate volume 30 - 80 cc. At 19 centers in North America and Australia, 206 men with symptomatic LUTS were randomized to PUL (N = 140) or sham control (N = 66). Patients and assessors were kept blinded to treatment arm for 3 months. Assessments for PUL subjects continued through 5 years. RESULTS PUL patients experienced symptom relief by 1 month (IPSS: 44% and QoL: 42%, p < 0.001) and remained improved through 5 years (IPSS: 38% and QoL: 54%, p < 0.001). Peak urinary flow rate remained improved 41% at 5 years. Sexual function was preserved in the PUL cohort, as assessments show stable erectile function average score and improved ejaculatory function and ejaculatory bother average scores (p<0.001). Further, no patient was found to experience de novo, sustained erectile or ejaculatory dysfunction. Adverse events were typically mild and transient. CONCLUSIONS The final long term data from the largest study on the PUL procedure demonstrates that this minimally invasive approach improves symptoms durably. Quality of life, BPH impact index and peak flow rate improvements are also sustained. As assessed by questionnaires and adverse event reporting, erectile and ejaculatory function are preserved. The final 5 year analysis indicates stable symptom relief and facilitates the understanding of the long term effects of the PUL procedure. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e511 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Claus Roehrborn More articles by this author Steven Gange More articles by this author Neal Shore More articles by this author Jonathan Giddens More articles by this author Damien Bolton More articles by this author Barrett Cowan More articles by this author Anthony Cantwell More articles by this author Kevin McVary More articles by this author Peter Chin More articles by this author Alexis Te More articles by this author Shahram Gholami More articles by this author Prem Rashid More articles by this author William Moselely More articles by this author Ronald Tutrone More articles by this author Sheldon Freedman More articles by this author Peter Incze More articles by this author K. Scott Coffield More articles by this author Fernando Borges More articles by this author Daniel Rukstalis More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

MP27-18 CROSSOVER STUDY ON THE PROSTATIC URETHRAL LIFT (PUL): 4 YEAR RESULTS

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II1 Apr 2017MP27-18 CROSSOVER STUDY ON THE PROSTATIC URETHRAL LIFT (PUL): 4 YEAR RESULTS Henry Woo, Jack Barkin, Damien Bolton, Prem Rashid, Anthony Cantwell, William Bogache, Stephen Richardson, Ronald Tutrone, James Fagelson, and Peter Chin Henry WooHenry Woo More articles by this author , Jack BarkinJack Barkin More articles by this author , Damien BoltonDamien Bolton More articles by this author , Prem RashidPrem Rashid More articles by this author , Anthony CantwellAnthony Cantwell More articles by this author , William BogacheWilliam Bogache More articles by this author , Stephen RichardsonStephen Richardson More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , James FagelsonJames Fagelson More articles by this author , and Peter ChinPeter Chin More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.810AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES PUL is a unique, non-thermal approach to treating lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia. We present the 4-year data from a sham to Prostatic Urethral Lift (PUL) crossover study in which each patient served as his own control. METHODS 53 patients underwent control sham procedure as part of a blinded, controlled study. After 3 months, these men with symptomatic LUTS were treated with crossover PUL that involved placing UroLift® implants into the obstructing lateral lobes of the prostate. They were followed for 4 years with validated tools such as International Prostate Symptom Score (IPSS), quality of life score (QoL), BPH Impact Index (BPH II), peak flow rate, sexual function scores, and adverse event reporting. RESULTS Average IPSS improved after sham but returned to near baseline after 3 months, while peak flow rate (Qmax) remained mildly elevated (Fig 1). At 4 years after crossover PUL, average scores for IPSS, QoL, and BPHII remained improved 45%, 49%, and 44% from baseline, respectively (p<0.001). Average peak flow rate increase of at least 50% over baseline was demonstrated at 4 years (p=0.01). On average, patients returned to normal activity within 7 days. Related adverse effects were typically transient and mild to moderate in severity. There were no reported instances of de novo, sustained erectile or ejaculatory dysfunction. CONCLUSIONS Similar to other publications, the 4 year results of the crossover study indicate the PUL procedure can result in rapid and durable improvement in symptoms, quality of life, and peak flow rate. Subjects report minimal adverse effects and return to normal quickly. Sexual function appears to be preserved. This study offers a unique perspective on the effectiveness of PUL, as the sham response is quantified for each patient. PUL is demonstrated to have a significant, non-placebo response that is durable to four years. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e336 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Henry Woo More articles by this author Jack Barkin More articles by this author Damien Bolton More articles by this author Prem Rashid More articles by this author Anthony Cantwell More articles by this author William Bogache More articles by this author Stephen Richardson More articles by this author Ronald Tutrone More articles by this author James Fagelson More articles by this author Peter Chin More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

24-month durability after crossover to the prostatic urethral lift from randomised, blinded sham.

To evaluate the 24-month effectiveness of the prostatic urethral lift (PUL) procedure in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) assessed through a crossover study. In all, 53 patients underwent a sham procedure as part of the blinded, randomised L.I.F.T. (Luminal Improvement Following prostatic Tissue approximation for the treatment of LUTS secondary to BPH) study at 19 centres and elected to enrol in this crossover study. The crossover procedure involved placement of permanent implants (UroLift® system) into the prostatic lateral lobes. Patients were followed for 3months after the sham procedure and then for 24months after crossover to PUL, with assessments of urinary symptom relief, quality of life (QoL), urinary flow rate, sexual function, and adverse events. At 24months after crossover to PUL, the International Prostate Symptom Score (IPSS), QoL, BPH Impact Index, and maximum urinary flow rate improved 36%, 40%, 54%, and 77% from baseline, respectively. Each IPSS parameter on average improved significantly from baseline (P<0.005) and remained stable throughout follow-up. Symptom response after the sham procedure indicated initial improvement at 1month with significant decay by 3months. Adverse events were typically mild to moderate and patients returned rapidly to normal activity. Four patients (8%) required intervention with transurethral resection of the prostate and one patient required additional PUL implants within the 24-month period. There were no reported instances of de novo sustained erectile or ejaculatory dysfunction. The PUL procedure is associated with rapid symptom relief, increased urinary flow rate and QoL improvement that remain stable over 24months. Morbidity is low and sexual function is preserved.

Benign prostatic hyperplasia and new treatment options - a critical appraisal of the UroLift system.

The prostatic urethral lift procedure, more commonly known as UroLift, has been designed to improve male lower urinary tract symptoms while avoiding the complications and disadvantages of existing drug and surgical therapies. In particular, UroLift does not damage ejaculatory function or affect orgasmic sensation. It appears an option for men who wish to avoid long-term drug therapy, the side effects of drugs or surgery and who do not need or will not accept traditional surgical treatments. UroLift was introduced following a series of planned studies that led to US Food and Drug Administration approval in September 2013. UroLift has recently been approved by the UK National Institute for Clinical and Health Excellence (September 2015) as effective and safe and cost-effective for use in the UK health system. This review describes the device and the procedure and the evidence base that has led to those approvals.

PD21-02 PROSPECTIVE, RANDOMIZED, BLINDED STUDY OF PROSTATIC URETHRAL LIFT (PUL): FOUR YEAR RESULTS

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology I1 Apr 2016PD21-02 PROSPECTIVE, RANDOMIZED, BLINDED STUDY OF PROSTATIC URETHRAL LIFT (PUL): FOUR YEAR RESULTS Claus Roehrborn, Steven Gange, Neal Shore, Jonathan Giddens, Damien Bolton, Barrett Cowan, Anthony Cantwell, Kevin McVary, Peter Chin, Alexis Te, Shahram Gholami, Prem Rashid, William Moseley, Ronald Tutrone, Sheldon Freedman, Peter Incze, K. Scott Coffield, Fernando Borges, and Daniel Rukstalis Claus RoehrbornClaus Roehrborn More articles by this author , Steven GangeSteven Gange More articles by this author , Neal ShoreNeal Shore More articles by this author , Jonathan GiddensJonathan Giddens More articles by this author , Damien BoltonDamien Bolton More articles by this author , Barrett CowanBarrett Cowan More articles by this author , Anthony CantwellAnthony Cantwell More articles by this author , Kevin McVaryKevin McVary More articles by this author , Peter ChinPeter Chin More articles by this author , Alexis TeAlexis Te More articles by this author , Shahram GholamiShahram Gholami More articles by this author , Prem RashidPrem Rashid More articles by this author , William MoseleyWilliam Moseley More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , Sheldon FreedmanSheldon Freedman More articles by this author , Peter InczePeter Incze More articles by this author , K. Scott CoffieldK. Scott Coffield More articles by this author , Fernando BorgesFernando Borges More articles by this author , and Daniel RukstalisDaniel Rukstalis More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.1469AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The Prostatic Urethral Lift (PUL) procedure offers rapid, durable improvement in lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia with minimal adverse effects. PUL was assessed through a large, multi-center, randomized, blinded trial with 4 year follow up. METHODS 206 men with symptomatic LUTS secondary to benign prostatic hyperplasia (BPH) were randomized to PUL (N=140) or sham control (N=66) at 19 centers in North America and Australia. Enrollment criteria included age = 50 years, IPSS (International Prostate Symptom Score) = 13, peak flow (Qmax) = 12 ml/s, and prostate volume 30 - 80 cc. With endoscopic guidance, small, permanent metallic implants were transurethrally placed into the lateral lobes of the prostate. The lobes were held in a retracted, open position which reduced urinary obstruction. Through 3 month post index procedure, patients and assessors were kept blinded to treatment arm. PUL participants were assessed through 4 years via IPSS, quality of life (QOL), BPH Impact Index (BPH II), Qmax, Sexual Health Inventory for Men (SHIM), and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). RESULTS Average IPSS reduction was 44% by 1 month and 46% at 4 years (p value < 0.0001). Adverse events such as hematuria, dysuria, pelvic pain, urgency, and urge incontinence were typically mild and transient. There were no reported de novo, sustained erectile or ejaculatory adverse events. Sexual function assessments (SHIM, MSHQ-EjD) show stable erectile function average score and statistically improved average ejaculatory scores. For those subjects who have reached their 4 year follow up, 19 subjects have undergone repeat PUL or other procedure. CONCLUSIONS PUL patients suffer from little morbidity and on average achieve rapid, clinically meaningful LUTS relief. This preliminary data from the largest and longest study of the PUL procedure demonstrates that relief can be sustained to 4 years. In addition, sexual function is preserved, both in terms of erection and ejaculation. Durability will be assessed through protocol driven follow up through 5 years. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e456-e457 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Claus Roehrborn More articles by this author Steven Gange More articles by this author Neal Shore More articles by this author Jonathan Giddens More articles by this author Damien Bolton More articles by this author Barrett Cowan More articles by this author Anthony Cantwell More articles by this author Kevin McVary More articles by this author Peter Chin More articles by this author Alexis Te More articles by this author Shahram Gholami More articles by this author Prem Rashid More articles by this author William Moseley More articles by this author Ronald Tutrone More articles by this author Sheldon Freedman More articles by this author Peter Incze More articles by this author K. Scott Coffield More articles by this author Fernando Borges More articles by this author Daniel Rukstalis More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Prostatic Urethral Lift: A New Minimally Invasive Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Introduction: Prostatic urethral lift (PUL) is a minimally invasive procedure for the treatment of lower urinary tract symptoms (LUTSs) secondary to benign prostatic hyperplasia (BPH). The PUL procedure involves the placement of implants that retract the obstructing prostate lobes. This procedure achieves quantifiable improvements in functional outcomes and quality of life (QoL), while preserving erectile and ejaculatory functions. Methods: Seventeen patients diagnosed with BPH who had undergone the UroLift® procedure between March 2011 and June 2015 were retrospectively evaluated. The parameters evaluated in the pre-operative, intra-operative and 1-year post-operative period were demographic data, and pre-operative, intra-operative and 1-year post-operative results were obtained from the International Prostate Symptom Score (IPSS), Uroflowmetry QoL index, International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire (MSHQ) for ejaculatory function (MSHQ-EjD). Results: The average improvements from baseline to 12 months after intervention were significant for the total IPSS 9.6. There was a 4.2-point increase in Qmax, a 0.9-point improvement in QoL and a 32% decrease in PVR. No statistically significant difference was found in the IIEF and MSHQ-EjD scores when the pre-operative and post-operative 3rd and 12th month scores were evaluated (p > 0.05). Conclusions: PUL offers rapid improvement in voiding and storage symptoms, QoL and flow rate that is durable to 12 months after intervention. PUL is a minimally invasive procedure that has the moderate effect in treating troublesome LUTS secondary to benign prostatic obstruction and preserving total sexual function.