Neurological and Urodinamic Urology Arch. Esp. Urol. 2013; 66 (6): 584-591 UROLIFT®, A NEW MINIMALLY INVASIVE TREATMENT FOR PATIENTS WITH LOW URINARY TRACT SYMPTOMS SECONDARY TO BPH. PRELIMINARY RESULTS Pablo Garrido Abad, Almudena Coloma del Peso, Bryan Sinues Ojas and Manuel Fernandez Arjona. Urology Department. Hospital del Henares. Coslada. Madrid. Spain. Summary.- OBJECTIVES: To report the preliminary results of one of the first series of patients treated with a new simple surgical technique for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) and to evaluate its safety and feasibility. METHODS: We have performed a novel surgical treatment of BPH, the UroLift® System (Neotract, Inc). It opens the urethra directly by retracting the obstructing prostatic lobes without applying incisions, surgical resection or thermal injury to the prostate. @ RESULTS: The procedure was carried out in 20 patients with a mean age of 74.3 (43-90) years, with mean prostate volume of 42.6 mL (19-109) using the same operative protocol in all case subjects. Mean operative time was 19.1 min (range: 12-45). International Prostate Symptom Score (IPSS) at 4 weeks reduced from 26.7 to 16.7 and peak urinary flow rate (Qmax) increased from 8.6 mL/s to 13.2 mL/s. No major complications were encountered, neither sexual dysfunction. Mean follow-up: 12.3 (2-22) months. CONCLUSIONS: The UroLift® System procedure appears to be safe and efficient at short term. This technique minimizes the bleeding of the urethra and, therefore, makes bladder catheter not always necessary, and can preserve sexual function with low morbidity. Further studies are warranted to determine long-term outcome. Keywords: UroLift®. Benign prostatic hyperplasia. Minimally invasive surgical therapy. LUTS. CORRESPONDENCE Pablo Garrido Abad. Servicio de Urología Hospital del Henares. Avda. Marie Curie s/n 28820. Coslada. Madrid (Spain) [email protected] Accepted for publication: February 18th, 2013 Resumen.- OBJETIVO: Presentar una de las primeras series de pacientes tratados con una nueva y sencilla técnica quirúrgica para los síntomas del tracto urinario inferior secundaria a HBP, evaluando su seguridad y eficacia con resultados preliminares. MÉTODOS: Se ha empleado una nueva técnica para el tratamiento quirúrgico de la HBP, el UroLift® System (Neotract, Inc.), que aumenta el calibre de la uretra prostática de forma directa, retrayendo los lóbulos prostáticos obstructivos sin realizar incisiones, resección quirúrgica o daño térmico sobre el tejido prostático. RESULTADOS: El procedimiento ha sido realizado sobre 20 pacientes (media edad: 74.3 años) con un volumen 585 P. Garrido Abad, A. Coloma del Peso, B. Sinue Ojas, et al. medio prostático de 42.6 cc. (19-109) y empleando el mismo protocolo en todos los casos. El tiempo medio de la intervención fue 19.1 min (7-45). La puntuación del International Prostate Symptom Score (IPSS) a las 4 semanas se redujo de 26.7 a 16.7 y el Flujo máximo (Qmax) se incrementó desde 8.6 mL/s hasta 13.2 mL/ s. No se presentaron complicaciones mayores, ni afectación de la función sexual. Seguimiento medio: 12.3 (2-22) meses. Primary objectives of this study were the assessment of the procedure effectiveness, and also evaluate the number and severity of serious adverse events (AE) related to the placement of the implants. Before treatment all patients underwent TRUS and cystoscopy to determine the dimensions and structure of the prostate and exclude those with middle lobe or urethral stenosis. CONCLUSIONES: El dispositivo UroLift® parece eficaz y seguro a corto plazo. Está nueva técnica minimiza el sangrado de la uretra prostática y, por tanto, no hace siempre necesario el empleo de sondaje vesical posterior. Además presenta una baja morbilidad, preservando la función sexual. Sin embargo debemos esperar los resultados de un número mayor número de pacientes tratados mediante esta nueva técnica y con seguimientos más prolongados para extraer conclusiones más firmes. All patients were ≥ 50 years, with moderateto-severe symptomatic BPH, with IPSS >20, Qmax. under 15mL/s, and serum PSA level of < 10 ng/ml. Following the same inclusion/exclusion criteria for UroLift ® used by all authors until now, patients were excluded if they had an obstructive median lobe in cystoscopy and/or current infection in urine culture previous to procedure. Also were excluded patients with previous prostate surgery. Palabras clave: UroLift®. Hiperplasia benigna prostática. Tratamiento mínimamente invasivo. STUI. All procedures were performed by a single surgeon, under the same surgical protocol, and with the same antibiotic prophylaxis: i.v 400mg Ciprofloxacin and 5 days of oral 500mg Ciprofloxacin. INTRODUCTION BPH is the most common condition in aging men, associated with LUTS and is associated with bladder outlet obstruction (BOO). Despite the goldstandard surgical treatment of BOO, transurethral resection of the prostate (TURP) has some limitations and is associated with significant complications and morbidity. Therefore, a demand for technologic alternatives that can minimize the risks of TURP exists (1). The UroLift® System (Neotract, Inc., Pleasanton, CA, USA.) is a minimally invasive procedure to treat symptomatic BPH, using next-generation device that facilitates the surgery under local anesthesia. It opens the urethra directly by retracting the obstructing prostatic lobes without applying incisions, surgical resection or thermal injury to the prostate. Patients were not excluded if they had history of a-adrenergic receptor blocker medication or 5-a reductase inhibitor medication. Effectiveness parameters included the International Prostate Symptom Score (IPSS), BPH Impact Index (BPH II) and Qmax rate, Safety was assessed through adverse event recording (AE). Follow-up assessments were conducted at 4 weeks, 3, 6 and 12 months. The assessments included AE reporting, uroflowmetry, IPSS and BII. PATIENTS AND METHODS The implantation procedure goal is to create a channel through the anterior prostatic urethra from bladder neck to veru montanum. Implants are delivered to both right and left lateral lobes (usually at the 2:30 and 9:30 position on the clock) advancing from approximately 1.5 cms distal to the bladder neck, after pivoting laterally to approximately 2030 degrees from center. To avoid mucosal abrasion with the movements of the cystoscopy sheath is very important to turn the device 90 degrees to either side inside the bladder and not to rotate it while within the prostatic fossa. The number of UroLift®‚ implants required is typically four, but depends on prostate size and configuration. Retrospective study of our first 20 male patients treated with the new device (UroLift® System, Neotract, Inc.) between October 2010 and June 2012. The procedure was performed with the patient in lithotomy position and using a standard cystoscopy to access the bladder transurethrally. After that, a 20F Storz cystoscopy sheath and a 2.9 mm 0° telescope We report our preliminary results of this novel surgical technique for the treatment of LUTS due to BPH. This is one of the first reports of patients treated with UroLift® system in Europe. UROLIFT®, A NEW MINIMALLY INVASIVE TREATMENT... 586 prostatic capsule. A stainless steel urethral end-piece (8 mm x 1 mm x 0.5mm) was secured onto the suture monofilament (size 0 polyethylene terephthalate (PET) non absorbable) apposed to the urethral wall, and the excess suture was cut. First 2 patients were performed under spinal anaesthesia, and next 18 patients were given only minimal intravenous sedation. Figure 1. The UroLift® System (Images copyright NeoTract, Inc.) was inserted for using an implant delivery device. (Figures 1,2,3) This device, contains a 19G needle, and once the delivery device was deployed in an anterolateral direction through the gland to access the extracapsular space, a non-absorbable monofilament suture with a nitinol capsular tab (0.6 mm diameter x 8 mm long) was then advanced through the hollow needle. The needle was retracted and tension was applied to the suture to seat the capsular tab on the Five patients (25%) also presented diabetes, 12 (60%) hypertension (TAS > 160; TAD > 90), 10 (50%) cardiac insufficiency (NYHA III-IV) and 3 (1.5%) nephropathy (defined as Cr > 2.0 mg/dL). Seven patients (35%) were under oral antiagregant drugs, and in 2 cardiovascular high risk patients (10%), this medication was not discontinued before surgery. To test the changes from baseline a general estimating equation model was fit to each output parameter (IPSS, BPHII, and Qmax). This model was used to calculate the P values for each follow-up interval compared with the baseline value, using a paired non parametric Wilcoxon´s t test. Statistical significance was defined as P < 0.05. Figure 2. Delivery sequence of UroLift® device (Images copyright NeoTract, Inc.) Figure 3. Intraoperative view of the procedure. After treatment the urethral piece of the suture is deeply invaginated (arrow) into the urethra. 587 P. Garrido Abad, A. Coloma del Peso, B. Sinue Ojas, et al. RESULTS Mean (range) preoperative IPSS was 26.7 (20-35), and mean (range) preoperative Qmax was 6.9 mL/s (0-13) including all patients. If we exclude 4 patients (20%) that were using a bladder catheter before surgery, because chronic retention, Qmax was 8.6 mL/s. (3-13). The mean (range) age was 74.3 (43-90) years; Transrectal ultrasound (TRUS) prostate volume was 42.6 (19-109) mL; Mean operating time was 19.1 (7-45) mins, and the mean (range) UroLift® number of sutures implanted per patient was: 3.8 (26), 1.69 in right lobe and 2.15 in left lobe. Mean (range) follow-up was 12.3 (2-22) months, and mean (range) hospital stay was 20.6 hours (3-72). All patients have been assessed at 4 weeks follow-up visit, with mean (range) IPSS of 16.7 (1027), with 10.0-point mean improvement (37.5%). Mean Qmax was 13.2 mL/s, increase: (+4.5) mL/s if we exclude 4 patients with bladder catheter before surgery. 17 patients (85%) achieved 3 months of follow-up, with mean (range) IPSS of 16.6 (10-27), with 9.9-point mean improvement (36.3%). Mean Qmax. was 13.5 mL/s for 17 patients, with an overall increase of (+4.8) mL/s excluding 4 patients with bladder catheter before surgery. Until now, 14 patients (80%) have done the assessment at the 6 month follow-up visit with mean (range) IPSS: 17.3(1121) and improvement of 9.1-point (34.5%). 6 month follow-up Qmax rate: 13.1 mL/s, increase: (+4.5) mL/s, excluding patients with previous catheter. 10 patients 50% have done the 12 months follow-up Table I. IPSS, BPHII and Qmax values, by visit. All values are mean. IPSS BPHII Qmax mL/s Baseline 4 weeks 3 months * 6 months * 12 months * (N=20) (N=20) (N=17) (N=13) (N=9) Baseline 26.7± 6.0 26.7 ± 6.0 26.5 ± 5.9 26.4 ± 5.9 26.3 ± 6.0 Follow-up - 16.7 16.6 17.3 15.3 Change - - 10.0 - 9.9 - 9.1 -11.0 % Change (95% CI) - 37.5% 37.3% 34.5% 41.8% P - .001 < .001 .001 .008 Baseline 8.4 ± 2.3 8.4 ± 2.3 8.4 ± 2.2 8.4 ± 2.2 8.4 ± 2.2 Follow-up - 5.1 5.3 4.9 5 Change - - 3.3 - 3.1 - 3.5 - 3.4 % Change (95% CI) - 38.3% 36.5% 41.6% 40.5% P - .001 .001 .001 .006 Baseline 8.6 ± 2.9 8.6 ± 2.9 8.7 ± 2.8 8.6 ± 2.8 8.6± 2.8 Follow-up - 13.2 13.5 13.1 12.8 Change - + 4.5 + 4.8 + 4.5 + 4.2 % Change (95% CI) - 51.7% 55.2% 52.3% 48.3% P - .002 . 003 .008 .042 * Sample size reduced because not all patients had reached this follow-up visit 588 UROLIFT®, A NEW MINIMALLY INVASIVE TREATMENT... visit, with mean IPSS: 15.3, 11-point improvement (41.8%) and Qmax: 12.8 mL/s, increase: (+4.2) mL/ s excluding patients with previous catheter (Table I). Mean (range) BPH II basement value was 8.4 (5-12). Mean (range) BPH II was 5.1 (2-8), with a 3.3-point improvement (38.3%) at 4 weeks visit. Mean (range) BPH II was 5.3 (2-8), with a 3.1-point improvement (36.5%) at 3 months of follow-up; Mean (range) was 4.9 (2-7), with an improvement of 3.5point (41.6%) at 6 months. Finally mean (range) BPH II was 5.0 (3-7), with 3.4-point improvement (40.5%) at 1 year of follow-up (Table I). Some random patients were also evaluated with cystoscopic examination after procedure. No one showed calcification, migration or malfunction of the implants. Most commonly reported adverse effects were mild dysuria (14 patients: 70%), and urgency (8: 40%), and typically resolved within 2 weeks. Mild haematuria presented in 6 patients (30%) and stopped in all cases before 15 days (Table II). Related serious adverse events were 2 urinary retentions (10%) and 1 acute epididymo-orchitis (5%). No patients reported urinary incontinence, subjective changes in erectile function or ejaculation after procedure, but no validated IIEF or MSHQ-EjD questionnaires were filled (Table II). Postoperative catheterization was necessary in 2 patients (10%). This patient undergone TURP 6 months after UroLift® because continuing with micturition severe difficulties. In this case, during TURP the resecting loop cut the suture and does not require alteration to standard procedure. This patient was excluded from the analysis of treatment effectiveness after the completion of their TURP but included in the complete safety analysis. DISCUSSION BPH is the main reason for lower urinary tract symptoms LUTS due to urethral blockade. Moderateto-severe LUTS is estimated to affect 30% of men aged > 50 years or ª 26 million men in Europe (2). There are 3 kinds of treatments for patients with BPH: watchful waiting, medical and surgical treatment. Whereas medical treatment using alphablockers or 5-α reductase inhibitors is the first-line treatment of BPH (3). Surgical therapy is an option for patients that are unable to tolerate medical therapy or for whom medical therapy is not efficacious. Traditional surgical therapy consists of TURP, which is still considered the gold standard, the hallmark of the urologist, the one against which other therapeutic measures are compared (4). Approximately 10% of patients with BPH require surgical treatment (5). In some cases, surgery could be the first choice for treatment rather than medical therapy. Approximately 8% of subjects receiving medical therapy require subsequent surgical therapy (6). Table II. Device-related AEs ocurring in the first 30 days after the Urolift® procedure. Number of patients (%) Mean duration (N=20) (days) Dysuria 14 (70%) 6.8 Irritative symptoms 8 (40%) 16.4 Haematuria 6 (30%) 4.1 Urinary retention 2 (10%) 7 Epididymo-orchitis 1 (5%) 21 Erectile dysfunction 0 (0%) - Ejaculation disorders 0 (0%) - AE 589 P. Garrido Abad, A. Coloma del Peso, B. Sinue Ojas, et al. TURP is assotiated with a 14.9-point mean IPSS improvement at 1 year but has a 20% rate of perioperative morbidity and longterm complications that include urinary incontinence (3%), urethral stricture (7%), erectile disfunction (10%) and ejaculatory dysfunction (65%) (7-10). Less invasive alternatives to TURP include: Transurethral microwave thermotherapy (TUMT), Transurethral needle ablation (TUNA), Laser ablation: Neodimium YAG laser (Nd: YAG), holmium YAG laser (Ho:YAG), potassium titanyl phosphate (KTP), and diode laser, High-intensity focused ultrasound (HIFU), Transurethral ethanol ablation of the prostate, Water-induced thermotherapy and Plasma kinetic tissue management system (Gyrus) (11). Open surgery for LUTS secondary to BPH is reserved for patients with very large symptomatic prostate glands or those with concomitant pathology such as large bladder stones or symptomatic bladder diverticula (4). Most procedural approaches remove or destroy prostate tissue and can result in significant morbidity. Exists then an unmet clinical need for an alternative treatment that caters men who desire a greater symptomatic improvement than is offered by medical therapy and are not willing to risk the complications of a surgical treatment (12). The UroLift® delivery device mechanically separates the obstructing prostatic lobes without tissue removal or thermal injury. The lateral lobes of the prostate are displaced towards the capsule to expand the urethral lumen. Small suture-based implants are then positioned to secure the lobes and maintain the expanded urethra (12). The UroLift® system treatment present several advantages: a) Endoscopic results can be immediately confirmed post-procedure, b) The procedure may be performed under local anesthesia, c) Some patients can avoid any catheterization, d) Patients may experience symptom relief as early as 2 weeks post-procedure, e) There have been no reports of new onset of sexual dysfunction, retrograde ejaculation or permanent erectile dysfunction, f) UroLift®‚ system treatment does not preclude the option for future TURP should one be indicated. According to Barkin et al, we recommend starting with prostates 50cc or below to learn the technique. These glands will require fewer implants as the urologist learns the most efficient locations at which to retract the lateral lobes (13). In the literature review, Woo et al reported a prospective, non-randomized, multi-center clinical study in Australia to establish the safety and feasibility of the UroLift® device in 19 male patients ≥55 years of age with a diagnosis of symptomatic BPH: the mean (SD; range) age was 66 (55–77) years, and TRUS prostate volume was 49 (21–97) mL. Patients with obstructive prostatic middle lobe, current infection, history of urinary retention, α-adrenergic receptor blocker medication within 1 week of treatment, or 5α-reductase inhibitor medication within 6 months of treatment were excluded. Before treatment, the patients underwent TRUS and cystoscopic examination to determine the dimensions and structure of the prostate and to confirm study eligibility. All patients were given general anaesthesia before undergoing the PUL in the lithotomy position. Two to five sutures were positioned in each patient (mean: 3.5). Postoperative catheter was not required in 6 patients (31.5%), 11 patients (58%) were catheterised overnight and 2 patients (10.5%) needed catheter for 6 and 11 days. 3 patients (15.7%) underwent TURP after one-year follow up. Mean IPSS improved by 37% at 2 weeks and 39% at 1year after Urethral Lift. No significant change of maximum flow rate, postvoid residual and prostate-specific antigen was measured.(12) After that,Chin et al also reported another 10 cases performed with local anesthesia and i.v sedation, using a next-generation device. The procedure was well tolerated, and improvements were seen at 2 weeks. Mean baseline IPSS value was 22.9. Improvement was 41% (- 9.4) at 2 week followup, 46.2% (- 10.6) at 1 year follow-up, and 41% (-9.4) at 3 years follow-up. Mean baseline QOL was 4.9, with an improvement of 44% (-2.2) at 2 weeks of follow-up, and of 51% (-2.5) at 1 year of follow-up. Mean baseline BPH II was 7.3, with an improvement of 39% (-2.9) at 2 weeks follow-up and 60% (-4-4) at 1year follow-up. (14) More recently, Woo et al presented in AUA 2011 results of a multicenter study. 64 patients (mean age: 67 years; mean prostate volume: 50mL). All procedures were successfully completed; 33 under local anesthesia with a mean catheter duration of 1.5 days. Reported adverse effects: dysuria, hematuria and frequency resolved within 2 weeks. Normal UROLIFT®, A NEW MINIMALLY INVASIVE TREATMENT... sexual function was maintained with no incidence of retrograde ejaculation (15). Actually a Phase III RCT “The Safety and Effectiveness of Urolift: LIFT Pivotal Study” is ongoing in US. All subjects will be followed through 12 months, and through 5 years for those that receive investigational device. Primary effectiveness will be achieved by looking at the improvement of IPSS and safety will be reviewed based on pertinent adverse events. There is no publication about patients treated with UroLift‚ system and previous treatments with prostate radiotherapy or brachytherapy. In spite of a higher number of patients and longer follow-up, our preliminary results are in concordance with previous results reported in literature. Patients in our serie had a decrease in IPSS of 37.5, 37.3. 34.5 and 41.8% at 4 weeks, 3, 6 and 12 months of follow-up respectively. After procedure, BPH II had also a decrease in 38.3, 36.5, 41.6 and 40.5% at 4 weeks, 3, 6 and 12 months of followup respectively, without serious adverse events. Our Qmax increase was impressive, with 51.7, 55.2, 52.3 and 48.3% at 4 weeks, 3, 6 and 12 months visit. IPSS lower improvement in our serie could be determined by the older (74.3 years vs 66-67 years of other series) and lower number of patients included in our publication. 1 patient (5%) with prostate volume > 80cc, did not present any improvement and underwent TURP without incidences. In future patients we should try starting to perform this procedure under local anaesthesia (instilation of 20cc of cold lidocaine gel into the urethra and the bladder 20 min before surgery), with much more benefits for the patient, because a shorter recovery and making possible to proceed with UroLift system in Consultation room. After our preliminary results we confirm previous reported findings that the Prostatic Urethral Lift is a safe and feasible treatment for symptomatic BPH that can preserve sexual function with low morbidity. According to our experience, UroLift® is not only suitable for high risk patients with previous treatment failures, and also for patients with BPH and LUTS as a first line surgical option after failure or adverse effects of oral medication. 590 CONCLUSION The Urolift® system is safe and feasible, and represents an alternative solution for men with LUTS due to benign prostatic hyperplasia (BPH) for whom medical therapy is no longer desirable but the risk/ benefit profile of TURP is not attractive. No major complications were reported, and moreover normal sexual function is preserved. Improvements are sustained through 1 year of follow up. We think that patients with prostate volume (20-50cc) are the best candidates to UroLift®, and larger prostates (> 75cc) develope poor results. Nevertheless, further studies are indicated to continue evaluating this promising technique. REFERENCES AND RECOMMENDED READINGS (*of special interest, **of outstanding interest) 1. Zhao Z, Zeng G, Zhong W, Mai Z, Zeng S, Tao X. A Prospective, Randomised Trial Comparing Plasmakinetic Enucleation to Standard Transurethral Resection of the Prostate for Symptomatic Benign Prostatic Hyperplasia: Three-year Followup Results. Eur Urol. 2010;58:752–758. 2. Cornu JN, Cussenot O, Haab F, Lukacs B. A widespread population study of actual medical management of lower urinary tract symptoms related to benign prostatic hyperplasia across Europe and beyond official clinical guidelines. Eur Urol. 2010 Sep;58(3):450-6. 3. Shin YS, Park JK. Changes in Surgical Strategy for Patients with Benign Prostatic Hyperplasia: 12-Year Single-Center Experience. Korean J Urol 2011;52:189-193. 4. Sandhu JS. Therapeutic options in the treatment of benign prostatic hiperplasia. Patient Prefer Adherence. 2009; 3: 213–223. 5. Crowley AR, Horowitz M, Chan E, Macchia RJ. Transurethral resection of the prostate versus open prostatectomy: long-term mortality comparison. J Urol.1995;153:695–697. *6. Saigal CS, Movassghi M, Pace J, Joyce G. Economic evaluation of treatment strategies for benign prostatic hyperplasia--is medical therapy more costly in the long run? J Urol. 2007;177:1463– 1467. 7. Roehrborn CG, McConnell JD, Barry MJ. American Urological Assotiation Guideline: Management of Benign Prostatic Hyperplasis (BPH). American Urological Assotiation Education and 591 Research, Inc. 2003. 8. Miano R, De Nunzio C, Asimakopoulos AD, Germani S, Tubaro A. Treatment options for benign prostatic hiperplasia in older men. Med Sci Monit 2008;14:RA94-102. 9. Rassweiler J, Teber D, Kunt R, Hofmann R. Complications of transurethral resection of the prostate (TURP)- incidence, management and prevention. Eur Urol 2006;50:969-80. 10. Montorsi F, Moncada I. Safety and tolerability of treatment for BPH. Eur Urol Suppl 2006;5:100412. 11. Dhingra N, Bhagwat D. Benign prostatic hyperplasia: An overview of existing treatment. Indian J Pharmacol. 2011;43(1): 6–12. **12. Woo HH, Chin PT, McNicholas TA, Gill HS, Plante MK, Bruskewitz RC, Roehrborn CG. Safety and feasility of the prostatic urethral lift: A novel, minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU INT. 2011;108:82-8. *13. Barkin JB, Giddens J, Incze P, Casey R, Richardson S, Gange S. UroLift system for relief of prostate obstruction under local anesthesia. Can J Urol. 2012;19(2):6217-22. 14. Chin PT, Woo HH, McNicholas TA, Gill HS, Plante MK Bruskewitz RC y cols. The prostatic urethral lift: Update on a novel treatment for lower urinary tract symptoms secondary to BPH conducted with local anesthesia. Eur Urol Supp. 2010; 9;2:278. 15. Woo H, Chin P, Bolton D, Rashid P, Macqarie P, Thavaseelan J y cols. Prostatic urethral lift further characterized: a multi-center experience. J Urol Supp. 2011;185.4S:846.
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