Multicentre prospective crossover study of the prostatic urethral lift for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia

Multicentre prospective crossover study of the
‘prostatic urethral lift' for the treatment of lower
urinary tract symptoms secondary to benign
prostatic hyperplasia
Anthony L. Cantwell, William K. Bogache*, Steven F. Richardson†, Ronald F. Tutrone‡,
Jack Barkin§, James E. Fagelson¶, Peter T. Chin†† and Henry H. Woo‡‡
Atlantic Urological Associates, Daytona Beach, FL, *Carolina Urological Research Center, Myrtle Beach, SC, †WesternUrological Clinic, Salt Lake City, UT, ‡Chesapeake Urology, Baltimore, MD, USA, §University of Toronto, Toronto, ON,Canada, ¶Urology Associates of Denver, Denver, CO, USA, ††Figtree Private Hospital, Figtree, and ‡‡Sydney AdventistHospital Clinical School, University of Sydney, Sydney, NSW, Australia • To assess the clinical effect of the ‘prostatic urethral lift' • Symptom, flow, HRQL and sexual function assessments (PUL) on lower urinary tract symptoms (LUTS) associated showed response improvements from baseline results, with benign prostatic hyperplasia (BPH) through a similar to results from other published studies, and most crossover design study.
parameters were markedly improved after PUL vs the shamprocedure in the same patients.
Patients and Methods • Symptom, flow, and HRQL improvements were durable over the 12 months of the study.
• Men aged ≥50 years with an International Prostate • Adverse events associated with the procedure were typically Symptom Score of ≥13, a maximum urinary flow rate (Qmax) transient and mild to moderate; one patient (2%) required of ≤12 mL/s, and a prostate of 30–80 mL were enrolled into re-intervention with transurethral resection of the prostate a crossover study after completing a prospective, in the first year.
randomised, controlled, ‘blinded' pivotal study in which they • There were no occurrences of de novo, sustained ejaculatory were control subjects receiving a sham procedure.
or erectile dysfunction.
• Patients were followed for 1 year after crossover PUL at 19 centres in the USA, Canada and Australia. The sham procedure involved rigid cystoscopy with simulated active • The PUL can be performed under local anaesthesia, causes treatment sounds.
minimal associated perioperative complications, allows • PUL involved placing permanent UroLift® (NeoTract, Inc., patients to quickly return to normal activity, provides rapid Pleasanton, CA, USA) implants into the lateral lobes of the and durable improvement in symptoms, and preserves prostate to enlarge the urethral lumen.
sexual function.
• Urinary symptom relief, health-related quality of life (HRQL) impact, urinary flow parameters, sexual function, and adverse events were assessed and compared between prostate, benign prostatic hyperplasia, minimally invasive the sham and PUL using paired statistical analysis.
surgical procedure, crossover, sham, sexual function perioperative risk [1–4]. Small UroLift® implants (NeoTract,Inc., Pleasanton, CA, USA) are delivered transurethrally to BPH is common in men beyond middle age and often causes separate the lateral lobes of the prostate and relieve bothersome LUTS that can detrimentally affect a man's obstruction. Previously published studies have reported health-related quality of life (HRQL). The ‘prostatic urethral symptom reduction considerably greater than drugs, faster lift' (PUL) is a mechanical approach to addressing LUTS that acting and more durable than thermal therapies, and without has the potential to offer rapid and significant mitigation of the more serious complications associated with TURP or laser symptoms, preservation of sexual function and minimal [1–4]. We report on a group of patients who underwent a 2013 The AuthorsBJU International 2013 BJU International doi:10.1111/bju.12540 BJU Int 2014; 113: 615–622
Published by John Wiley & Sons Ltd. www.bjui.org Cantwell et al.
sham procedure followed by PUL 3–6 months later. These for devices and support personnel opened packaging patients allow for analysis of the individual effect of active vs materials. Then, at appropriate times during the procedure, the sham procedure, a rare opportunity in medical device clinical operator simulated the UroLift delivery device sounds by activating a standard disposable biopsy device that was notinserted into the patient.
Crossover studies have been shown to effectively comparerelative therapeutic effects of pharmaceutical treatments withplacebo or other treatments, but this design has rarely been Study Procedure the PUL used to study medical devices [5–8]. The primary challenges The PUL involves the delivery of permanent in situ tailored with conducting a medical device crossover study design are: transprostatic UroLift® implant (NeoTract, Inc., Pleasanton, (i) while sham control groups can crossover to active CA, USA) to reshape the prostatic fossa, allowing for a treatment, it is not possible to cross active arm subjects back continuous channel through the anterior aspect of the prostate to control; and (ii) while ‘blinding' can be maintained for (Fig. 1) [1–4]. Under cystoscopic visualisation through a 20 F sham, it is typically not feasible to maintain a ‘blind' when sheath, the system compresses the obstructing tissue and these subjects crossover to active treatment. Device trials delivers through a hollow 19-G needle a monofilament that consequently use the ‘one-way' instead of the ‘two-way' traverses the prostate lobe with a metallic tab seated on the crossover design. We sought to compare the effects of PUL capsular surface. The monofilament is tensioned and sized in when delivered 3–6 months after a sham procedure using this situ to fit the compressed prostate lobe. A urethral end piece is self-controlled paired data set.
then affixed to the monofilament, which is trimmed to thenewly fixed length. Typically four implants are delivered tocreate a continuous anterior channel.
Patients and MethodsA crossover study of the PUL procedure after sham control was conducted at 19 centres in the USA, Canada, andAustralia in men with moderate to severe LUTS secondary to The IPSS, HRQL (as assessed by the eighth question of the BPH. While enrolled in a randomised double-blind study IPSS), and BPH Impact Index (BPHII) were assessed at published by Roehrborn et al. [3], patients underwent a sham baseline and 2 weeks, 1 and 3 months after both the sham and procedure that involved rigid cystoscopy and mimicking PUL procedures and additionally at 6 and 12 months after the surgical sounds. After the primary endpoint comparison at 3 PUL. The five-item version of the International Index of months, these sham controls were unblinded and, if eligible, Erectile Function (IIEF-5, equivalent to the Sexual Health offered enrolment into the crossover study, where they were Inventory for Men [SHIM]) and the Male Sexual Health treated with PUL and followed to 12 months.
Questionnaire for Ejaculatory Function (MSHQ-EjD) andBother (MSHQ-Bother) were assessed at baseline and 1 and Eligible patients for the crossover study were aged ≥50 years, 3 months after both the sham and PUL procedures and provided informed consent, had no prior surgical BPH additionally at 6 and 12 months after the PUL in patients who treatment, and were either washed out or naïve to α-blockers were sexually active. Qmax and PVR were assessed at 3 and 12 and 5α-reductase inhibitors. Each patient had an IPSS score of months. Safety was assessed at each follow-up visit through ≥13, a maximum urinary flow rate (Qmax) of ≤12 mL/s with a adverse event reporting. An independent Clinical Events voided volume of 125 mL, and a prostate of volume of Committee (CEC) adjudicated all reported events, and an 30–80 mL without an obstructing median lobe. Patients were independent reviewer over-read each flow waveform using the excluded for retention, post-void residual urine volume (PVR) two-second rule.
of >250 mL, active infection, PSA level of >10 ng/mL unlessnegative biopsy, cystolithiasis within 3 months, and bacterial Statistical Methods prostatitis within 1 year. The study protocol was approved bythe USA Food and Drug Administration, Health Canada, and Descriptive statistics were used to describe the baseline and the Therapeutic Goods Administration of Australia, as well as follow-up values of all study parameters (IPSS, HRQL, BPHII, the Institutional Review Boards at each of the 19 enrolling Qmax, PVR, SHIM, and MSHQ-EjD). Where stated, values are sites (Clinicaltrials.gov: NCT01294150).
reported as the mean (standard deviation). The changebetween baseline and 3 months for the sham procedure vs thePUL was compared using a paired Student's t-test, in which Control (Sham) Procedure each patient served as their own control. Additionally, a The sham control procedure was conducted in a manner that general estimating equation model (GEE) was fitted to each simulated PUL. A visual obstruction was erected in the room study output parameter. The change from baseline was the so that the recumbent patient could not see the operator or dependent variable; baseline score and visit were the endoscopy image. During rigid cystoscopy, the operator called independent variables. In this model, an exchangeable 2013 The Authors 616 BJU International 2013 BJU International

PUL for the treatment of LUTS Fig. 1 The Prostatic Urethral Lift procedure.
(a & b) Before treatment, the enlarged lateral
lobes obstruct the urethra. (c & d) After
transurethral delivery through a 19 gauge
needle, the UroLift® implants reshape the prostate to allow for a patent channel through the anterior aspect of the prostatic fossa.
correlation structure and identity link were used and P values Table 1 Baseline characteristics for patients who elected crossover PUL
for each follow-up interval compared with baseline were procedure 3–6 months subsequent to receiving a rigid cystoscopy shamprocedure.
calculated using SAS (SAS Institute, Inc. Cary, NC) and R (TheR Foundation, Vienna, Austria); a P < 0.05 was considered to Cross-over PUL (n = 53)
indicate statistical significance.
Mean (SD, range)
64 (8.0, 50–79) Prostate volume, mL* 40.3 (9.9, 30–68) 23.3 (5.5, 13–34) HRQL (IPSS question 8) 6.3 (3.0, 1–12) 8.8 (4.2, 2.0–30.0) Between February and December 2011, 66 men underwent a 67.8 (66.44, 0–262) sham procedure as part of a ‘blinded' randomised study [3].
2.26 (1.85, 0–8) 12.8 (8.3, 1–25) After unblinding at 3 months, 53 subjects (80%) elected to 9.5 (10.0, 3–14) enrol in this crossover study and undergo PUL (Table 1). Overthe 12-month follow-up, no PUL patient required α-blocker *Baseline data was used for those patients who did not have data collected immediatelybefore crossover. therapy and one (2%) progressed to a standard TURPintervention, which was completed without complication.
The mean (SD) crossover PUL procedure time was 53 (15) patient enrolled in North America underwent general min for delivering a mean (range) of 4.4 (2–8) implants in anaesthesia; 44/46 (96%) of procedures were conducted under prostates ranging in volume from 30 to 70 mL. While local anaesthesia using cold lidocaine with sedative and the Australian standard of care required general anaesthesia, no remaining two (4%) used prostatic block. Of the 53 patients 2013 The Authors BJU International 2013 BJU International 617
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Table 2 Baseline, follow-up, and change in each outcome measure (IPSS, HRQL, BPHII, MSHQ-EjD, MSHQ-Bother, and IIEF-5) after control sham therapy
followed by crossover PUL in the same patient cohort. Each parameter is presented as the mean (SD). The 3-month change in each parameter in the
control vs crossover period was compared using a paired Student's t-test.
Control sham therapy period
Crossover PUL period
(paired sample size, n)
HRQL, IPSS question 8 (52) IIEF-5 (SHIM) (36) *Baseline value was defined as the value before the initial sham procedure for the Control group and the value before PUL for the Cross-over group. Note that the baseline value for theCrossover group was 3–6 months after the sham procedure. undergoing crossover PUL, 41 underwent void trial after the Fig. 2 Comparison of the IPSS from baseline to 3-month follow-up for
procedure. No postoperative catheterisation was required for patients who underwent sham procedure and later crossover PUL 27 (66%) of these tested patients, and the mean catheter procedure. Also plotted are the ‘blinded' and randomised results from duration for all patients was 33 h. The PUL patients reported a Roehrborn et al. [3] on PUL only patients. Crossover PUL IPSS improvement mean (SD) complete return to preoperative activity by 6.5 (6.8) is significantly greater than that of sham and closely mimics prior published results. Values shown are the mean absolute IPSS, error bars represent the 95% CI.
The therapeutic effect of the PUL was significantly greater than that seen for the sham procedure in this crossover study.
The mean IPSS improvement after crossover PUL (11.1 points) was 122% greater than after sham (5.0 points) at 3 months (P < 0.001; Table 2). The IPSS reduction seen in crossover PUL patients closely mimics that of previously published randomised results (Fig. 2) [3]. Improvements in HRQL(IPSS question 8) and BPHII, were also significantly greater for crossover PUL patients vs sham (P < 0.001 and P =0.024, respectively). Qmax showed stepwise improvement, increasing from 7.9 (2.4) mL/s at baseline to 10.3 (4.6) mL/s 3months after sham and further increasing to 12.0 (6.1) mL/s and 12.5 (5.3) mL/s at 3 and 12 months after crossover PUL, respectively (Fig. 3). The PUL showed clinically and statistically significant improvement in IPSS, HRQL, BPHIIand Qmax throughout the course of the 12-month study(Tables 3,4). Sexual function was maintained with no pelvic pain/discomfort (21%) (Table 5). No patient required a significant degradation in SHIM or MSHQ-EjD at any time blood transfusion and haematuria typically resolved within 3 point after the PUL, and the general trend was improvement days. The patients who reported pelvic pain or discomfort at in all measures after the PUL (Table 3). Ejaculatory function the 1 month visit rated their pain on a visual analogue scale.
showed a statistically significant difference between the sham The mean pain scores after the PUL showed no significant procedure, which decreased ejaculatory function, and the PUL difference those after the sham procedure (2.71 and 2.67 out treatment, which increased ejaculatory function, at 3 months of 10, respectively; P = 0.9). There was no incidence of de novo, sustained erectile dysfunction or retrograde ejaculation.
One patient progressed to TURP 12 months after treatment due to persistent nocturia.
The adverse events reported for PUL were typically mild to Related adverse events were also examined using the Clavien- moderate and resolved within 2 weeks; the most commonly Dindo classification. Most were mild, typically Class I or II, occurring events were dysuria (36%), haematuria (26%), and while none were Class IV or V. There were two Class III 2013 The Authors 618 BJU International 2013 BJU International
PUL for the treatment of LUTS Table 3 IPSS, HRQL, BPHII, SHIM, MSHQ-EjD, and change from baseline (after sham procedure and before PUL) after PUL. P values were obtained from a
general estimating equation.
12 Months
n (paired) Mean % change (95% CI) −18 (−27, −10) −46 (−53, −39) −48 (−56, −40) −43 (−52, −34) −37 (−46, −27) HRQL (IPSS question 8) n (paired) Mean % change (95% CI) −20 (−32, −9) −43 (−53, −33) −49 (−59, −39) −44 (−53, −35) −41 (−53, −29) n (paired) Mean % change (95% CI) −41 (−59, −23) −52 (−64, −41) −53 (−64, −42) −44 (−58, −30) n (paired) n (paired) n (paired) events, each of those was a patient who presented in hospital when he underwent TURP; the remaining implants were left for urinary retention; one was discharged the same day with a in situ as they were asymptomatic; the patients will be catheter and the other was readmitted for 2 days.
In all, 48 patients, with a total of 215 implants, underwentcystoscopy at 12 months. An independent reviewer found no evidence of encrustation on the implants delivered within the The results of this crossover study show that, with each patient prostate, no increase over baseline in oedema or inflammation, serving as his own control, the PUL procedure is associated no de novo strictures, and no evidence of abnormal pathology with a clinically and statistically significant treatment effect in the prostatic urethra. Surface encrustation was observed on beyond sham therapy. The crossover PUL LUTS improvement 10 implants (4.7%) that were inadvertently delivered such that is consistent with that observed when comparing separate part of the implant was exposed to urine within the bladder.
randomised groups. The mean (SD) 3-month IPSS Two of these 10 implants were removed using cystoscopic improvement after crossover PUL was virtually identical to grasping forceps and two were removed from a single patient that seen with a separate group of patients in a ‘blinded' 2013 The Authors BJU International 2013 BJU International 619
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Fig. 3 Qmax shows stepwise improvement starting at baseline, improving 3
baseline of enrolment was 10.6 points, again consistent with months after sham, and further improving 3 months after crossover PUL.
the 10.8 and 12.3 point improvements at 12 months reported The improvement after crossover is stable through to the 12-month in prior studies [3,4]. A possible explanation for this cumulative effect is that dilatation during the sham procedure does not fully dissipate by 3 months but appears to no longercontribute to overall effect by 12 months.
By contrast, urinary flow rate change was more durable after sham rigid cystoscopy. At 3 months after sham cystoscopy, there was a 2.4 mL/s increase in Qmax from baseline. Aftercrossover PUL, Qmax further improved 2.5 mL/s at 3 months and was maintained to 12 months. The cumulative 12 months Qmax improvement of 4.6 mL/s is similar to the 4.0 mL/s improvement reported in both randomised and open labelstudies [3,4]. The continued improvement in flow after the sham procedure may be a result of a lingering dilatory effect from rigid cystoscopy.
For a minimally invasive approach, patient satisfaction is oftendetermined by return to normal activity and perioperativecomplications [9]. Morbidity associated with the PUL Table 4 Qmax and PVR change from baseline (after sham procedure and
before PUL) after PUL. P values were obtained from a general estimating
procedure was low as was the need for postoperative catheterisation. Adverse events were as expected after a rigidcystoscopic intervention, with most events transient and either 12 Months
mild or moderate. Pelvic pain was tracked carefully, and visual analogue scores were not different between the PUL and sham n (paired) procedures. On average, PUL patients returned to normal preoperative activity in less than a week, which is considerably more rapid than the 4–6 weeks typical of other BPH therapies [10]. In PUL procedures conducted in the USA and Canada, Mean % change (95% CI) all were conducted with local anaesthesia (96%) or prostate n (paired) After the crossover PUL procedure, no patient had new onset, sustained ejaculatory or erectile dysfunction. Further, sexual function measures in the ‘erectile function', ‘ejaculatory Mean % change (95% CI) 9.26 (67.35, −48.84) 4.67 (55.70, −46.36) function', and ‘ejaculatory bother' domains improved after PUL at every time point, although most changes were notstatistically significant. This preservation in overall sexualfunction after a BPH procedure stands in contrast to the randomised study, at 11.1 (7.2) vs 11.1 (7.7), respectively [3].
41–65% rates of ejaculatory dysfunction and 7–10% rates of In both comparisons, the improvement after the PUL was erectile dysfunction reported for TURP or laser procedures significantly greater than the effect of sham rigid cystoscopy.
[11–13]. Iatrogenic sexual dysfunction can significantly affect This high level of repeatability serves as a validation of the HRQL [14]. One study has shown that 19% of men would consistent therapeutic effect of the PUL. Both ‘blinded' and even forego treatment for cancer if it compromised their crossover (open-label) PUL patients had rapid, durable relief sexual function [15]. While erectile function is more with minimal morbidity and virtually no sexual compromise.
commonly analysed, ejaculatory function has also been foundto be of high importance to many patients [16]. The increase There was a change in IPSS score at 2 weeks for both sham in ejaculatory function after PUL compared with the and crossover PUL. For the sham procedure, this could be due functional compromise after the sham procedure, suggests that to the psychological effect of undergoing a treatment and the PUL may be uniquely suited to treat LUTS while preserving temporary urethral dilatation associated with rigid cystoscopy.
sexual function and is consistent with the prior randomised From 2 weeks to 3 months, the sham effect begins to diminish, while the PUL effect continues to improve. In the longer term,the 12-month IPSS improvement from the time of crossover The primary strength of the present study lies in the statistical was 8.7 points, but the cumulative improvement from true power associated with the paired measures analysis that was 2013 The Authors 620 BJU International 2013 BJU International
PUL for the treatment of LUTS Table 5 Overview of adjudicated adverse events of interest.
0–3 months
Control (n = 53)
Cross-over (n = 53)
Cross-over (n = 53)
pelvic pain/discomfort urgency incontinence urinary tract infection erectile dysfunction* retrograde ejaculation* *Sexual dysfunction adjudicated as new onset and sustained. Related, device or procedure related; SAE, serious adverseevent; AE, adverse event. permitted because each patient served as his own control. The results from this self-controlled data set, which included The authors would like to thank Drs Rodney Anderson, Kyle open-label PUL therapy, corroborates previously published Anderson, and Parker Eberwein for serving on the CEC, and results from a randomised study. In contrast to the Drs Harchi Gill and James Yu for conducting independent randomised study, the analysis of the self-controlled data set review of flow waveforms. In addition, the authors want to may provide more insight into what the patient response express appreciation to the staff of NeoTract, Inc., Five might be outside of a clinical study. In everyday use, the Corners Pty. Ltd., CMX Research, Inc., QST Consultations, patient generally has free will to choose the treatment, perhaps LTD, and Myraqa, Inc. for their assistance in study conduct, in view of previous other treatment failures. It could be argued manuscript preparation, and statistical analysis. This study was that the crossover phase comes closer to assessing the results funded by NeoTract, Inc.
expected for a commercialised product under a free willchoice. The fact that the results from the randomised andcrossover phases are similar is reassuring.
Conflict of Interest Conversely, some weaknesses of the study must be recognised; A.L.C.l., W.K.B., S.F.R., R.F.T., J.B., J.E.F. l., and P.T.C. have been notably, the duration of follow-up is only to 1 year at this investigators for the Neotract sponsored study from which this point. An earlier study showed a similar reduction in IPSS at 1 data has been extracted.
year (10.4 vs 10.6 points observed in the present study) and H.H.W. and P.T.C. have been consultants to Neotract and hold 2-year durability of LUTS improvement, thereby providing stock in Neotract.
some evidence of the longevity of this minimally invasivetherapy [2]. Additionally, as the present study includedopen-label PUL therapy, the possibility of a placebo effect cannot be excluded. However, the consistency between the Woo HH, Chin PT, McNicholas TA et al. Safety and feasibility of the
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