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

Figures & data

Figure 1 Applying a tissue retracting implant between the urethra and the prostatic capsule lifts the urethra toward the capsule thereby expanding the urethral lumen.

Notes: Because the prostate capsule is firm, fibromuscular tissue and the glandular lobe tissue is compressible and sponge-like (A), when the prostate wall is compressed, the urethra is lifted toward the outer capsule, and the capsule holds position. Thus, the prostatic urethra can be opened (B).

Figure 2 UroLift^® system handpiece and implant.

Notes: The handpiece is passed under vision down the urethra and into the prostatic channel. The lateral prostatic lobes are separated to open the channel and fixed in the operator’s chosen position by firing the handpiece mechanism that delivers an implant. The implant consists of: an urethral end piece made of surgical steel; a capsular tab made of nitinol; and a length of suture made of PET. During the procedure, the suture is cut to a customized length by the handpiece under the direction of the surgeon.
Abbreviation: PET, polyethylene terephthalate.

Table 1 Scientific studies of UroLift published in peer-reviewed journals

Feasibility studies (5 centers, Australia, n=64 at 2 years)

Chin et al.^Citation6

Woo et al.^Citation7

International registry (7 centers, 5 countries, n=102 at 1 year)

McNicholas et al.^Citation2

Crossover study (Sham randomized, crossed to PUL, n=53 at 1 year)

Cantwell et al.^Citation10

LIFT randomized study (PUL versus sham, n=206 RCT funded to 5 years)

Roehrborn et al.^Citation11 3 year data

Roehrborn et al.^Citation9 2 year data

Roehrborn et al.^Citation4 1 year data

McVary et al.^Citation8

LOCAL study (Local anesthesia tolerance, rapid recovery profile, n=51)

Shore et al.^Citation13

BPH6 randomized study (PUL versus TURP, n=80 to 1 year)

Sonksen et al.^Citation5

Meta-analyses

NICE MTEP assessment – MTG26 September 15, 2015

Shore.^Citation14

Perera et al.^Citation15

Abbreviations: PUL, prostatic urethral lift; LIFT, Long-Term Investigative Follow-Up in TrialNet; RCT, randomized controlled trial; LOCAL, UroLift system tOlerability and reCovery when Administering local Anesthesia; BPH, benign prostatic hyperplasia; TURP, transurethral resection of the prostate; NICE, National Institute for Clinical and Health Excellence; MTEP, Medical Technologies Evaluation Programme; MTG26, Medical technology Guidance 26.

Figure 3 Images of male prostatic urethra before (A) and immediately after (B) insertion of UroLift implants.

Note: Image used with patient’s permission.

Table 2 The 6 elements of the BPH-6 end point

BPH6 element	Assessment requirement	Rationale
LUTS relief	Reduction of ≥30% in IPSS at 12 mo compared to baseline	Analysis of large-scale randomized trials indicates that 30% IPSS improvement is a suitable threshold for patient satisfaction and treatment acceptability
Recovery experience	QoR VAS ≥70 by 1 mo	Postoperative return to normal activity is measured using a global QoR VAS with significant convergent validity with the QoR score, a postoperative recovery outcome with content and construct validity suitable for ambulatory surgery. The threshold of 70% by 1 mo is chosen to reflect high-quality, rapid recovery
Erectile function	Reduction of <6 points for SHIM compared to baseline during 12 mo follow-up	SHIM is widely used to measure the severity of erectile dysfunction in clinical practice, and >5 points has been used as the minimum clinically meaningful change
Ejaculatory function	Response to MSHQ-EjD question 3 indicating emission of semen during 12 mo follow-up	Absence of ejaculate has been quantified using the four-item MSHQ-EjD. Postoperative emission of semen is indicated by a “nonzero” response to the volume item of the questionnaire
Continence preservation	ISI score of ≤4 points at all follow-up intervals	The ISI consists of two questions on the frequency and amount of urinary leakage and bas been used in epidemiological surveys and clinical trials of LUTS treatment. An incontinence threshold of ISI >4 corresponds to the threshold for severe incontinence in the three-level index
Safety	No treatment-related adverse event greater than grade I on the Clavien–Dindo classification system at any time during the procedure or follow up	The Clavien–Dindo classification of surgical complications has been validated in many fields including urology. A threshold of grade II+ was selected to account for events that might significantly affect a patient’s postoperative course, such as those requiring surgery, endoscopy, radiology, or supranormal pharmacology. If a patient pursues secondary treatment, the failure to respond is captured in the effectiveness element (#1) and not the safety element (#6); the patient is therefore censored from the safety element analysis at all subsequent time points

Note: Reproduced from Sonksen J, Barber NJ, Speakman MJ, et al. Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study. Eur Urol. 2015;68(4):643–652.⁵

Abbreviations: BPH, benign prostatic hyperplasia; LUTS, lower urinary tract symptoms; IPSS, international prostate symptom score; QoR VAS, quality of recovery visual analog scale; SHIM, sexual health inventory for men, MSHQ-EjD, male sexual health questionnaire for ejaculatory dysfunction; ISI, incontinence severity index; mo, month.

Table 3 Outcomes of BPH-6: UroLift versus TURP randomized study

	PUL (%)	TURP (%)	P value
Qmax	41	144	<0.0001
Composite primary endpoint	52.3	20.0	0.005
#1) LUTS  (≥30% IPSS reduction)	72.7	91.2	0.05
#2) Recovery  (≥70% VAS at 1 mo)	81.8	52.9	0.008
#3) Erectile function  (<6 SHIM reduction)	97.4	93.9	0.6
#4) Ejaculatory function  (MSHQ-EjD #3≠0)	100	60.6	<0.0001
#5) Continence  (ISI <5)	85.0	75.0	0.4
#6) Safety  (no Clavien–Dindo II+)	92.7	78.8	0.1

Notes: Adapted from Sonksen J, Barber NJ, Speakman MJ, et al. Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study. Eur Urol. 2015;68(4):643–652.⁵ 80 men (45 UroLift: 35 TURP) followed to 1 year Primary endpoint met: BPH6 composite endpoint to reflect overall patient desires PUL superior to TURP, P=0.005.

Abbreviations: BPH, benign prostatic hyperplasia; TURP, transurethral resection of the prostate; PUL, prostatic urethral lift; Q_max, maximal urinary flow; LUTS, lower urinary tract symptoms; IPSS, international prostate symptom score; VAS, visual analog scale; SHIM, sexual health inventory for men; MSHQ-EjD, male sexual health questionnaire for ejaculatory dysfunction; ISI, incontinence severity index; mo, month.

Figure 4 Timeline of UroLift milestones.

Abbreviations: BPH, benign prostatic hyperplasia; TURP, transurethral resection of the prostate; LOCAL, UroLift system tOlerability and reCovery when Administering Local Anesthesia; FDA, US Food and Drug Administration; NHS, National Health Service; NICE, National Institute for Clinical and Health Excellence; MTEP, Medical Technologies Evaluation Programme.

ChinPTBoltonDMJackGProstatic urethral lift: two-year results after treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasiaUrology201279151122202539

 PubMed Web of Science ®Google Scholar

WooHHBoltonDMLabordeEPreservation of sexual function with the prostatic urethral lift: a novel treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasiaJ Sex Med20129256857522172161

 PubMed Web of Science ®Google Scholar

McNicholasTAWooHHChinPTMinimally invasive prostatic urethral lift: surgical technique and multinational experienceEur Urol201364229229923357348

 PubMed Web of Science ®Google Scholar

CantwellALBogacheWKRichardsonSFMulticentre prospective crossover study of the ‘prostatic urethral lift’ for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasiaBJU Int2014113461562224765680

 PubMed Web of Science ®Google Scholar

RoehrbornCRukstalisDBBarkinJThree year results of the prostatic urethral LIFT studyCan J Urol20152237772778226068624

 PubMed Web of Science ®Google Scholar

RoehrbornCGangeSShoreNDurability of the prostatic urethral lift: 2-year results of the L.I.F.T. studyUrol Pract201522632

 Google Scholar

RoehrbornCGGangeSNShoreNDThe 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. studyJ Urol201319062161216723764081

 PubMed Web of Science ®Google Scholar

McVaryKTGangeSNShoreNDTreatment of LUTS secondary to BPH while preserving sexual function: randomized controlled study of prostatic urethral liftJ Sex Med201411127928724119101

 PubMed Web of Science ®Google Scholar

ShoreNFreedmanSGangeSProspective multi-center study elucidating patient experience after prostatic urethral liftCan J Urol20142117094710124529008

 PubMed Web of Science ®Google Scholar

SonksenJBarberNJSpeakmanMJProspective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 studyEur Urol201568464365225937539

 PubMed Web of Science ®Google Scholar

ShoreNA Review of the Prostatic Urethral Lift for Lower Urinary Tract Symptoms: Symptom Relief, Flow Improvement, and Preservation of Sexual Function in Men With Benign Prostatic HyperplasiaCurr Bladder Dysfunct Rep201510218619225984251

 PubMedGoogle Scholar

PereraMRobertsMJDoiSABoltonDProstatic urethral lift improves urinary symptoms and flow while preserving sexual function for men with benign prostatic hyperplasia: a systematic review and meta-analysisEur Urol201567470471325466940

 PubMed Web of Science ®Google Scholar