ESUT 2022 Updates New techniques for Benign Prostatic Obstruction

CONGRESS & MEETING HIGHLIGHT

Carlo Giulioni

Department of Urology, Polytechnic University of Marche, Azienda Ospedaliera Universitaria della Marche, Ancona, Italy.

INTRODUCTION

New techniques for prostatic hypertrophy have emerged, in recent years, for prostatic hypertrophy. The aim of the development of these innovations is multiple: • Ensure the preservation of ejaculation, especially in the younger population. • Have an alternative to medical therapy for patients who cannot tolerate medical therapy. • Patients who are not candidates for endoscopic electrical energy or laser therapy.

Therefore, these techniques were developed to perform this procedure in outpatient or day-hospital settings without general or spinal anaesthesia needed. NON-LASER ABLATIVE TECHNIQUES FOR PROSTATIC HYPERTROPHY

Thermal and pressure energy has been implemented in surgical practice, obtaining promising outcomes. Water Vapor Treatment (WVT) is a new way in the field of minimally invasive surgical treatments to use radiofrequency to create thermal energy in the form of water vapour and apply thermal energy for BPO. During the treatment, 103˚C water vapour is convectively delivered into 37˚C prostate tissue, increasing the temperature of tissue within each treatment area to approximately 70˚C over the course of each 9-second treatment, resulting in instantaneous cell death. This system is intended to relieve symptoms, and obstruction and reduce prostate tissue associat-

ed with BPH. The condensation of water vapour releases stored thermal energy. Cell membranes are gently denatured, thereby causing immediate cell death, the vasculature is closed, and there is denervation of the alpha-adrenergic nerves within the treatment zone. Water vapour cannot penetrate the zonal boundaries and therefore stays within the zone it is injected. For the evaluation of WVT efficacy, Mynderse et al. reported lesion volumes after treatment through magnetic resonance imaging: at 3 and 6 months, the prostate volume had reduced by 91.8% and 96.5%, respectively (1). Moreover, in a 4-Year randomized trial overview on the safety and efficacy of the procedure, this procedure guaranteed significant symptom relief and improved quality of life that remained durable throughout 4 years, with a minimal physician learning curve (2). In summary, WVT has shown promising results for prostate volume 30-80 cc in the long term with a low retreatment rate and minimal sustained erectile dysfunction or retrograde ejaculation. Aquabeam® System is a novel technology that integrates real-time ultrasonic imaging with robotically executed surgeon-guided high-velocity waterjet ablation to precisely resect prostatic tissue. Aquablation therapy combines cystoscopic visualization, ultrasound imaging, and advanced planning software to provide the surgeon with a multidimensional view of the treatment area. As for the technique, in the lithotomy position, the 22F handpiece is inserted under direct vision into the prostatic urethra and it is advanced up to the bladder. The handpiece is placed at the 12 o’clock position of the bladder neck. Thus, the prostate is compressed, allowing the anterior tissue to fall below the range of motion of the water jet. Under real-time TRUS guidance, the target anatomic resection contour was defined to preserve the anatomy of the bladder neck, verumontanum area, ejaculatory ducts, and external urinary sphincter. Once the treatment map is complete, prostate tissue is precisely removed using a robotically controlled high-velocity heat-free waterjet that can move from the bladder neck to the apical part of the prostate. The robotic and waterjet technologies enable targeted and controlled tissue removal with rapid resection times that are highly consistent across all prostate sizes and shapes, and surgeon experience levels. The bladder was thoroughly irrigated to remove the residual floating tissue particles and blood clots. A Double-blind randomized clinical trial compared the efficacy of the Aquablation compared to 5-year postoperative outcomes of the Aquablation with TURP for men with medium-volume prostates (30-80 ml) (3). At 5 years, IPSS scores improved by 15.1 points for Aquablation and 13.2 points in TURP, with an improvement in peak urinary flow rate was 12.5% and 8.9% compared to baseline for Aquablation and TURP, respectively. Furthermore, procedure-related ejaculatory dysfunction was lower for Aquablation (7% vs. 25%). As for large-volume prostates, Desai et al. reported 2-year postoperative outcomes of the Aquablation for men with adenoma volume comprised between 80 and 150 ml: mean IPSS and IPSS quality of life improved from 23.2 to 5.8 and from 4.6 to 1.1, respectively, at 2 years (4). Antegrade ejaculation was also maintained in 98% of sexually active men after 2 years. In a systematic review including 9 studies, an improvement in terms of Qmax, QoL, IPSS, and PVR, evaluated after water jet dissection, was shown concerning the baseline in all the selected articles with a statistical not inferiority compared to TURP. Primarily bleeding (range 2.4–19%) urethral stricture (0.99%), and urinary retention (7.7%) were the most frequent complications, with a similar rate of the overall adverse event than in the endoscopic surgery (5). Moreover, in the sexually active subjects, appearance reduction in the International Index of Erectile Function (IIEF-5) for the aquablation arm was higher or comparable to the TURP arm with the maintenance of ejaculatory function after surgery. Given the high rate of postAquablation bleeding, the focal bladder neck cautery may be performed after the procedure. In a Multicentric uncontrolled clinical trial with 2,089 consecutive Aquablation procedures, postoperative bleeding requiring transfusion occurred in 17 cases (0.8%) and take-back to the operating room for fulguration occurred in 12 cases (0.6%) (6).

NON-ABLATIVE TECHNIQUES FOR PROSTATIC HYPERTROPHY

In patients with high anaesthetic risks, various devices have been devised to widen the lumen without affecting the prostate adenoma. The prostatic urethral lift (PUL) represents a novel minimally invasive approach that uses permanent implants which are cystoscopically deployed through obstructing prostatic tissue. It is one of the best techniques for the preservation of ejaculatory function. The PUL system consists of two main components: a transurethral delivery device with an integrated cystoscope and permanent nitinol and stainless steel implants. Once the surgeon positions the transurethral delivery device at the desired location, the implants are inserted and subsequently compress and retract the prostatic adenomatous tissue. The number of implants a patient requires depends on the length of the prostatic urethra, the amount of prostatic tissue and the presence of a median lobe, generally 4. Tissue remodelling is induced by localized compression between the capsular tab and the urethral end piece (7). PUL demonstrated satisfactory efficacy in the literature. A Multicenter randomizing clinical trial, reporting 3-years its postoperative outcomes, showed an improvement from baseline in total IPSS at 3 years was 41.1% and a significant increase in terms of Qmax (53%) and quality of life (48.8%) during the follow-up, with no sustained ejaculatory or erectile dysfunction events (8). However, any concerns about its reintervention rate occur. In the literature, the surgical reintervention rate for urethral lift has been estimated at 2% to 3% per year in the first studies. In a meta-analysis involving 11 studies with overall 2016 patients undergoing surgery endoscopy for BPO, 153 men needed surgical reintervention (9). Among them, 51% was transurethral resection of the prostate/laser (51.0%), 32.7% repeat prostatic urethral lift

and 19.6% device explant. The annual rate of surgical reintervention after urethral lift resulted in 6.0% per year (9). The temporary implanted nitinol device (TND) is deployed in the prostatic urethra and bladder neck. This process expands and reshapes the bladder neck and prostatic urethra, creating an open channel for the flow of urine. The device is made up of three elongated nitinol struts connected at the distal end, an antimigration anchoring leaflet, and a polyester retrieval suture. The technique: In the lithotomy position, using a standard 19 to 22 Fr cystoscope, the surgeon inserts the enclosed device through the cystoscope sheath and into the bladder. The device is then deployed and retracted so that the anchoring leaflet is under the bladder neck at the 6 o’clock position and the 3 struts are in the 12, 5, and 7 o’clock positions within the prostatic urethra. Once inserted, the bladder is drained, and the patient is discharged with simple analgesia. After a week, the patient has the device removed by using the retrieval suture and a special open-ended silicone catheter that allows the device to be collapsed and removed safely without a cystoscope or anaesthesia. Currently, no meta-analysis nor systematic review were published. A Multicenter singlearm clinical trial reported 36-month postoperative outcomes of men with prostate volumes less than 75 ml. Over 3 years, 81 men with reported sustained improvements in IPSS (20.7–8.55), IPSS Quality of life (3.96–1.76), and Qmax (7.71 mL/s to 15.2 mL/s) (10). Therefore, further investigation to evaluate the safety and efficacy of TND is needed. The Temporary Prostatic Stent (TPS) is a useful tool for immediate and efficacy control after insertion determining no urine leak, immediate voiding, and clear urine. It guarantees a peak flow of 12- 15 ml/sec according to bladder contractility, driven by stent the standard length and diameter of the prostatic tube. It is not ballooned, as vesical catheters do and, therefore, surface in contact with urine is 5 times lower than in a Foley catheter. It is a safe procedure due to the impossible passage through the sphincter without any risk of urethral injury or urethral bleeding. It is indicated also for the large bulbous urethra, and hypertonic sphincter (patient anxiety or neurologic origin). Describing the technique, the urethra is calibrated through a Bougie CH 22 or 24. The surgeon inserts to the same depth as the one noted with the Bougie and until the perception of the abutment of the device against the posterior wall of the bulbous urethra. Then the patient is required to contract his sphincter, unlocking the Luer connection between the stylet and pusher tube and allowing to retrieve the stylet by 5 cm. Afterwards, the pink bumper of the flattener tube is taken and the urologist should retrieve the pink bumper of the flattener tube to remove at once the flattener tube, stylet, and pusher tube. The retrieval suture is cut 3 mm beyond the meatus. Several advantages occur of this procedure: • Silicone composition: low risk of encrustation and bacterial colonization. • Single model: a unique length and a single diameter CH 20 for all prostates with a distance bladder neck-apex < 7cm or prostate volume <150 cc. • No migration: anti-migration wings and length of the bulbar tube. • Excellent tolerance: no balloon in contact with the trigone, no bladder spasms. • Immediate efficacy control after insertion: no leak, satisfactory bladder emptying. • Low risk of bacterial contamination: bacteria are flushed out by each voiding. • Sexual activity preserved: possible retrograde ejaculation.

However, data need to be validated by prospective studies or randomized trials. Prostatic artery embolization (PAE) is a minimally invasive treatment that is performed by an interventional radiologist, with a lower risk of urinary incontinence and sexual side effects compared to invasive surgical procedures such as TURP. The technique: A Foley catheter may be inserted to provide a reference point for the surrounding anatomy. PAE is performed through a small catheter under local anaesthesia with access through the femoral or radial arteries. The interventional radiologist will then guide the catheter into the vessels that supply blood to the prostate. An arteriogram is done to map the blood vessels. Non-spherical or spherical PVA particles or Polyzene-coated hydrogel microspheres are injected through the catheter to reduce prostate blood supply on both sides. Following this procedure, the prostate will begin to shrink, relieving and improving symptoms usually within days of the procedure. In an overview regarding 630 consecutive patients with BPH and moderate-to-severe LUTS, PAE was technically successful in 618 (98.10%) patients, with a discharge before 24 hours in all cases (11). Moreover, a significant change from baseline to last FU in IPSS, QOLS, Prostate Vol, PSA, Qmax, Residual Vol, and IIEF occurred, with only 2 major complications. Finally, a meta-analysis of clinical trials comparing the efficacy and safety of PAE versus established surgical therapies, with 5 studies and overall 708 patients included (12). The mean reduction in the IIEF-5 was lower after PAE compared with standard surgical therapies (3.80). All of the functional outcomes assessed were significantly superior after surgical standard treatments in terms of Qmax (3.62 ml/s), prostate volume (11.51 ml), PVR (11.86 ml), and PSA (1.02 ng/ml).

ACKNOWLEDGMENTS Dr. Carlo Giulioni has no conflict of interests.

REFERENCES

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3. Desai M, Bidair M, Bhojani N, et al. Aquablation for benign prostatic hyperplasia in large prostates (80-150 cc): 2-year results. Can J Urol. 2020; 27(2):10147-10153. 4. Gilling PJ, Barber N, Bidair M, et al. Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH. Can J Urol. 2022; 29(1):10960-10968. 5. Reale G, Cimino S, Bruno G, et al. “Aquabeam® System” for benign prostatic hyperplasia and LUTS: birth of a new era. A systematic review of functional and sexual outcome and adverse events of the technique. Int J Impot Res. 2019; 31(6):392-399. 6. Elterman Ds, Foller S, Ubrig B, et al. Focal bladder neck cautery associated with low rate of post-Aquablation bleeding. Can J Urol 2021; 28(2):10610-10613. 7. Roehrborn CG, Chin PT, Woo HH. The UroLift implant: mechanism behind rapid and durable relief from prostatic obstruction. Prostate Cancer Prostatic Dis. 2022; 25(1):79-85. 8. Roehrborn CG, Rukstalis DB, Barkin J, et al. Three year results of the prostatic urethral L.I.F.T. study. Can J Urol. 2015; 22(3):7772-82. 9. Miller LE, Chughtai B, Dornbier RA, McVary KT. Surgical Reintervention Rate after Prostatic Urethral Lift: Systematic Review and Meta-Analysis Involving over 2,000 Patients. J Urol. 2020; 204(5):1019-1026. 10. Amparore D, Fiori C, Valerio M, et al. 3-Year results following treatment with the second generation of the temporary implantable nitinol device in men with LUTS secondary to benign prostatic obstruction. Prostate Cancer Prostatic Dis. 2021;24(2):349-357. 11. Pisco JM, Bilhim T, Pinheiro LC, et al. Medium- and Long-Term Outcome of Prostate Artery Embolization for Patients with Benign Prostatic Hyperplasia: Results in 630 Patients. J Vasc Interv Radiol. 2016; 27(8):1115-22 12. Zumstein V, Betschart P, Vetterlein MW, et al. Prostatic Artery Embolization versus Standard Surgical Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis. Eur Urol Focus. 2019; 5(6):1091-1100.

CORRESPONDENCE Carlo Giulioni Department of Urology, Polytechnic University of Marche 71 Conca Street, 60126, Ancona – Italy E-mail: carlo.giulioni9@gmail.com Phone: +39 320/7011978 ORCID: 0000-0001-9934-4011