UroLift for Treating Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: A NICE Medical Technology Guidance Update

Knight, Laura; Dale, Megan; Cleves, Andrew; Pelekanou, Charlotte E; Morris, Rhys J.

doi:10.1007/s40258-022-00735-y

Cited by 6 publications

(7 citation statements)

References 18 publications

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“…Commonly reported advantages include feasibility as a day case procedure, short learning curve and a favourable complication profile in comparison to more invasive alternatives such as transurethral resection of the prostate (TURP) (Table 1). 1,2 It also seems to demonstrate long-term durability as a re-treatment rate <15% was recently reported in a 5 year follow up study. 3 Patient selection for urolift procedure has also been expanded as more recent studies have supported its application in patients with an indwelling urinary catheter as well as those with an obstructing median lobe.…”

Section: Introductionmentioning

confidence: 70%

Complications and device failures associated with urolift: Findings from the MAUDE database

et al. 2023

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Introduction: Urolift is an established intervention for symptoms of bladder outflow obstruction caused by benign prostate enlargement. Reported advantages include its minimally invasive profile, short learning curve and feasibility as a day case procedure. Our aim was to use a national registry as a means to evaluate the nature of complications and device failures that have been documented to occur. Methods: Retrospective review was performed of the US Manufacturer and User Facility Device Experience (MAUDE) database, a prospective register, which contains voluntarily submitted adverse events associated with surgical devices. Information collected include event timing, underlying cause, procedural completion, complications and mortality status. Results: Between 2016 and 2023, 103 device failures, 5 intra-operative complications and 165 post-operative complications (early: 151, late: 14) were registered. The commonest device problem (56%, n = 58) was failure of the implant to deploy with subsequent requirement for complete replacement. There were 50 cases of documented urosepsis. 62 patients with post operative haematuria were registered including 12 that underwent emergency embolisation. Other complications included stroke ( n = 5), pulmonary embolism ( n = 3) and necrotising fasciitis ( n = 1). Twelve ITU admissions were registered. In the reports, 22 cases were filed that recorded a hospital stay of 7 days or more. Eleven deaths were captured in the database over the study period. Conclusion: While urolift is recognised as less invasive intervention compared to alternatives such as transurethral resection of the prostate, serious adverse events have been reported to occur including death. Our findings can provide learning points for surgeons and allow for improved patient counselling and treatment planning accordingly.

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Section: Introductionmentioning

confidence: 70%

Complications and device failures associated with urolift: Findings from the MAUDE database

et al. 2023

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“…Prostatic urethral lift (UroLift), another minimally invasive surgical technique, has been recommended by the UK National Institute for Health and Care Excellence (NICE) for the treatment of LUTS. However, its effectiveness in treating large prostate volumes and obstructive middle lobes remains unclear [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of Water Vapor Thermal Therapy in the treatment of benign prostate hyperplasia: a systematic review and single-arm Meta-analysis

Jiang

Amier

et al. 2023

BMC Urol

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Background Benign prostatic hyperplasia (BPH) is a common chronic condition among men aged 50 or older, causing voiding and obstructive lower urinary tract symptoms. Water vapor thermal therapy (WVTT) using the Rezūm® system is a new minimally invasive surgical technique that is increasingly reported as a treatment for BPH. Methods The protocol was submitted to the PROSPERO registry. We searched PubMed, Web of Science, Embase, Cochrane Library and ClinicalTrials.gov up to July 29, 2022. Quality assessment was carried out by a 20-item checklist form prepared by the Institute of Health Economics (IHE). Double arcsine transformation was performed to stabilize the variance of the original ratio. When I2 > 50%, the random effect model was used to calculate the pooled parameters. Otherwise, the fixed effect model was used. 95% confidence intervals (CIs) were calculated. A leave-one-out sensitivity analysis was performed to evaluate the impact of each study on the pooled outcomes, and finally, Egger’s test was used to assess publication bias. Results A total of seven single-arm observational studies and one random controlled trial, including 1015 patients, were included. One year after WVTT, the International Prostate Symptom Score decreased by 11.37 (95% CI: -12.53, -10.21), the IPSS Quality of Life scale decreased by 2.59 (95% CI: -2.92, -2.26), the maximum urine flow rate increased by 5.26 ml/s (95% CI: 4.53, 5.99), and the postvoid residual decreased by 13.18 ml (95% CI: -24.32, -2.03). The most common complication was dysuria, with a pooled incidence of 21% (95% CI: 14%, 29%), and the second most common complication was hematuria, with a pooled incidence of 14% (95% CI: 10%, 18%). The pooled incidence of retreatment was 3% (95% CI: 2%, 5%). Conclusions WVTT is an attractive alternative to medication or more invasive surgical procedures and can serve as first-line therapy for men with BPH.

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“…PUL can be used to treat a wide range of prostate sizes and anatomies up to 100 cc; furthermore, it can be routinely performed as a day case procedure under sedation or local anaesthesia. 9 Some UK centres have even moved to an ambulatory setting outside of a traditional day (or inpatient) surgical setting thereby foregoing the need for anaesthetic support. 10,11 PUL randomized studies have demonstrated rapid and significant improvement in LUTS with durability through 5 years.…”

Section: Introductionmentioning

confidence: 99%

“…PUL uses transprostatic implants to relieve symptoms of urinary outflow obstruction without cutting, heating or removing tissue using an energy source. PUL can be used to treat a wide range of prostate sizes and anatomies up to 100 cc; furthermore, it can be routinely performed as a day case procedure under sedation or local anaesthesia 9 . Some UK centres have even moved to an ambulatory setting outside of a traditional day (or inpatient) surgical setting thereby foregoing the need for anaesthetic support 10,11…”

Section: Introductionmentioning

confidence: 99%

“…These hallmarks of PUL have been well‐documented in LUTS‐BPH patients with established voiding, albeit with obstructed uroflowmetric parameters. Proven gains relate to positive outcomes affecting both patient care and healthcare systems; these include increased efficacy, safety, efficiency and cost–benefit improvements 9 . Insofar as PUL is effective in treating AUR, adopting PUL into the clinical pathway for men with AUR should provide tangible quality improvements aligned to the principles set by the UK NHS Getting It Right First Time (GIRFT) initiative 13 .…”

Section: Introductionmentioning

confidence: 99%

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Prostatic urethral lift for subjects in urinary retention (PULSAR): 12‐Month results of a prospective controlled trial compared with real‐world outcomes

Rochester,

Doherty,

Page

et al. 2023

BJUI Compass

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ObjectiveTo examine the safety and efficacy of prostatic urethral lift (PUL) in acute urinary retention (AUR) patients within a controlled (PULSAR) and real‐world setting (Real‐World Retrospective study).Materials and methodsPULSAR was a 12‐month prospective study of PUL in AUR patients (n = 51) performed at six centres in the United Kingdom; enrolled BPH patients aged ≥50 years, with prostate volume of ≤100 cc. AUR was defined as being catheter dependent with at least one prior failed trial without catheter (TWOC) while on an alpha‐blocker. RWR consisted of 3226 consecutive PUL patients across 22 international sites treated between July 2017 and March 2020; 469 of whom were in urinary retention (RWRr), that is, catheter‐dependent at the time of their procedure. Symptom response, uroflow and catheter independence rates were compared between PULSAR and RWRr subjects. A logistical regression model was constructed to evaluate patient baseline and dynamic factors predicting success after the procedure.ResultsSeventy‐three percent of PULSAR subjects were catheter independent and free from surgical reintervention at 12 months post‐PUL. Success was associated with higher voiding efficiency during the perioperative period. Slightly higher catheter‐independent rates (80%) were seen in RWRr patients; variables that influenced success included age <70 years, lower baseline prostate‐specific antigen (PSA), lower baseline post‐void residual (PVR) and shorter pre‐procedural catheter duration. Logistic regression of the combined PULSAR and RWRr retention groups revealed that procedural age <70 years and higher bladder voiding efficiency (BVE) were associated with success.ConclusionsLower baseline PSA and PVR, younger age and shorter pre‐procedure catheter durations drove successful outcomes in AUR patients undergoing PUL. Post‐PUL voiding efficiencies may help ascertain long‐term response to treatment.

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UroLift for Treating Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: A NICE Medical Technology Guidance Update

Cited by 6 publications

References 18 publications

Complications and device failures associated with urolift: Findings from the MAUDE database

Complications and device failures associated with urolift: Findings from the MAUDE database

Efficacy and safety of Water Vapor Thermal Therapy in the treatment of benign prostate hyperplasia: a systematic review and single-arm Meta-analysis

Prostatic urethral lift for subjects in urinary retention (PULSAR): 12‐Month results of a prospective controlled trial compared with real‐world outcomes

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