REVIEW URRENT C OPINION

Outpatient surgery for lower urinary tract symptoms/benign prostatic hyperplasia: truth or myth? Shahin Tabatabaei and Mahdi Zangi

Purpose of review Worldwide, lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) is a common medical problem for aging men. Of patients who seek help with their symptoms, almost one-third do not respond to the medical therapy. These patients need a procedure that is safe, efficient, and durable, and at the same time carries minimal risk of side-effects. Many new technologies are introduced to our medical practice with the promise of being the ideal office-based procedure. In this review, we intend to review and discuss the role of three surgical procedures in an office setting. These include thermotherapy, 532-nm laser photo-selective vaporization of prostate, and bipolar plasma vaporization of prostate. Recent findings There are a few recent thermotherapy studies regarding the outcome of thermotherapy in LUTS/BPH patients. Data regarding the use of 532-ng laser photo-selective vaporization of prostate are scant but promising. The use of bipolar plasma vaporization is not well studied in an office setting. Summary In a select group of patients, thermotherapy and laser prostate surgery could be safely used to treat LUTS/ BPH patients. Bipolar plasma vaporization is a promising technology, but its use in an office setting has not been completely evaluated yet. Keywords ambulatory surgical procedures, benign prostatic hyperplasia, bipolar plasma vaporization, laser therapy, microwaves

INTRODUCTION Lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (LUTS/BPH) are prevalent [1,2]. An estimated 917 million men worldwide experienced LUTS/BPH in 2008, with a projected increase to 1.1 billion men in 2018 [3]. The incidence of hospitalized symptomatic BPH has doubled from 1998 to 2007. Age, genetic profile, lifestyle, and metabolic syndrome have interacted to raise the incidence of LUTS/BPH in men [4]. Currently, there are two primary management approaches to treating LUTS/BPH: pharmacotherapy and surgical/endoscopic intervention. A mono or combination therapy with a-receptor antagonists and 5 a-reductase inhibitors to reduce the tone or the size of the prostate adenoma are the main medical therapies for symptomatic BPH patients. It has been estimated that 4 billion dollars are spent for medical therapy of BPH every year in the USA alone [5]. Although the response to medical therapy is modest, the treatment is attractive to patients and

physicians alike. Patients may be able to avoid or postpone surgical intervention as long as they are on medication. However, poor compliance, sideeffects, and failure to respond to medication are not uncommon, leading one-third of the patients to seek surgical intervention. Options for surgical intervention include transurethral resection of the prostate (TURP), which has become the gold standard for surgical treatment of symptomatic LUTS/BPH that has failed medical therapy. Though the procedure offers a minimally invasive alternative to open simple prostatectomy, it carries a risk of short and long-term Massachusetts General Hospital, Boston, Massachusetts, USA Correspondence to Shahin Tabatabaei, MD, GRB-1102, Department of Urology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA. Tel: +1 617 726 3574; fax: +1 617 726 6131; e-mail: [email protected] Curr Opin Urol 2015, 25:27–31 DOI:10.1097/MOU.0000000000000127

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Male lower urinary tract symptoms

KEY POINTS  Despite recent developments, we have not succeeded to demonstrate an increase in efficacy and durability of outpatient BPH surgery.  Symptomatic patients with prostate size between 30 and 80 ml, without large median lobes and tight bladder necks, are considered good candidates for TUMT.  Patients with good physical status, minimal medical comorbidities, and a prostate volume of less than 60 ml benefit from the outpatient PVP as a safe option.  We have not found any well designed study of bipolar plasma vaporization in an outpatient setting.

complications. Failure to void, revision to open surgery, significant urinary tract infection, bleeding requiring transfusions, and transurethral resection (TUR) syndrome may occur postoperatively [6]. Furthermore, retrograde ejaculation, erectile dysfunction, urethral stricture, bladder neck contracture, and urinary incontinence represent the important side-effects of TURP that present during long-term follow-up [7]. There is a gap in management options between noninvasive, though less effective, medical therapy and relatively invasive, but more effective, surgical options. There are a growing number of patients who could benefit from an intervention that is more effective than medical therapy, but less invasive than TURP. Patients seek a procedure that is effective, noninvasive, and durable with a fast recovery and few side-effects. Patients’ concerns regarding the side-effects are more important in elective cases. Unless the patient is experiencing acute urinary retention or severe lower urinary tract symptoms, the patient will not be comfortable undergoing an effective procedure, if it is associated with a long recovery and/or sexual side-effects. Young patients may consider living with their LUTS to avoid potential sexual dysfunction or other change in their lifestyles. On the contrary, almost one-third of our patients are older LUTS/BPH patients who present with more complex medical morbidities. These patients are on antiplatelet and/or anticoagulation medication, and require a noninvasive, durable procedure. In the past three decades, many devices and endoscopic techniques have been developed to meet this demand. However, many of these procedures have failed to show an increase in efficacy and durability. Poor study design, the absence of a standardized method for evaluating new technology, and a paucity of clinical outcome data have 28

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limited the assessment of these technologies. In some cases, strong advertisement by device manufacturers has overshadowed the need to take the steps needed to ensure the safety and efficacy of the new procedures. In the following section, we focus on a few of the outpatient surgical therapies for LUTS/BPH and review the current data regarding their safety and clinical outcome.

THERMOTHERAPY Thermotherapy is a nonablative thermal therapy for LUTS/BPH developed to use a high temperature to cause coagulation or apoptosis in prostate adenoma and thereby reduce LUTS. The energy source could be heated water [water-induced thermotherapy (WIT)] or microwave energy [transurethral microwave therapy (TUMT)]. Through a transurethral catheter, the temperature rises to 55–608C. Although at these temperatures, some tissue necrosis and coagulation may occur, the extent of tissue necrosis is not significant enough to explain the symptom improvement. Some researchers suggest that a more extensive apoptosis, denervation of a-receptors, or decreased tone in the smooth muscles contribute to the relief of the patients’ symptoms. Transurethral microwave therapy does not require general anesthesia and can be performed in an outpatient setting. Most patients undergo the procedure with oral analgesics and/or mild sedatives, and transurethral lidocaine injection. After the procedure, patients are usually discharged home with minimal discomfort. Immediately after the procedure, some patients may notice a worsening of urinary symptoms. About 20% of patients may require temporary indwelling urethral catheterization or a temporary urethral stent. Therefore, it is suggested to continue or initiate a-blocker treatment with or without 5 a-reductase inhibitors to alleviate the initial worsening of LUTS after TUMT. TUMT complications are overall low and unremarkable. The risk of significant bleeding is negligible. TUMT carries a minimal risk of sexual dysfunction, making the procedure attractive to young patients. The low morbidity of the procedure and its lack of need for general anesthesia have also made TUMT an attractive alternative to more aggressive surgical ablative therapies to older men with major medical morbidities. Hoffman et al. [8] reviewed 15 randomized clinical trials of TUMT involving 1585 patients. Eight, six, and one studies compared the effectiveness of TUMT with sham thermotherapy, TURP, and alpha-blocker, respectively. The meta-analysis indicated a decline in the severity of urinary symptoms Volume 25  Number 1  January 2015

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Truth of BPH outpatient surgery Tabatabaei and Zangi

by 65% with TUMT and by 77% with TURP. Moreover, there was an increase in mean peak urinary flow by 70% with TUMT and by 119% with TURP. Interestingly, TUMT made a noticeable improvement in International Prostate Symptom Score (IPSS) and peak urinary flow compared to the sham thermotherapy and alpha-blocker. However, none of the TUMT clinical trials took into account the preexisting factors such as symptom duration, patient characteristics, prostate-specific antigen levels, and prostate volume that could affect early and late outcome. Aagaard et al. [9 ] presented their 12-year experience of carrying out TUMT in BPH patients unsuitable for open surgery, who suffered chronic urinary retention. Of the 124 patients, 115 had an indwelling catheter, and the remaining patients were managed with clean intermittent self-catheterization. The treatment was performed under local anesthesia in the outpatient setting. At the 6-month follow-up, 77% of the patients were able to void without a catheter and 79% reported improvement in their quality of life. Additionally, the median Post-Void Residual (PVR) urine Qmax, and Danish Prostatic Symptom Score (DAN-PSS) of the patients were 78 ml, 10 ml/s, and 3, respectively. Complications including insufficient heating of the prostate tissue, elevated rectal temperature, local anesthesia side-effects, and mild hematuria were seen in 5, 3, 6, and 4 patients, respectively. A review of TUMT published data indicates a wide range of outcomes. This is most likely due to variations in the study design, the definition of outcome measures, the type of TUMT device, the amount and duration of delivered energy, and, more importantly, patient selection. Patients with moderate to severe LUTS who are not responding to medical therapy and who present with the following prostate features are considered good candidates for TUMT: &&

(1) Absence of large median lobe (2) Absence of tight bladder neck (3) Prostate size between 30 and 80 ml. Despite encouraging reports in the literature, there has been a remarkable drop in TUMT and other thermotherapy procedures since their peak in 2005. A high rate of retreatment, suboptimal response to the treatment, and inadequate medical insurance coverage are the main causes of this drop.

PHOTO-SELECTIVE VAPORIZATION OF PROSTATE A 532-nm GreenLight laser has a higher absorption coefficient in hemoglobin than in water. For any

given laser energy, a blood vessel (red color) in a tissue absorbs more heat from the laser than the other part of the tissue (non red color). This absorption difference is used to achieve the selective coagulation of blood vessels in the background of a vaporized prostate. We have demonstrated this photo-selectivity in a study on patients with radiation cystitis [10]. This property is being used with this laser wavelength to achieve a better hemostasis in prostate ablative therapy. Further, several studies have shown that the hemostatic nature of this wavelength allows the prostate ablative procedure to be performed safely in patients who are on antiplatelet or anticoagulation medications. Although photo-selective vaporization of prostate (PVP) will be discussed in detail in a later chapter, we aim to focus on its application as an outpatient procedure. For an office-based prostate ablative surgery to be safe and efficient, a strong safety profile, adequate intraoperative and early postoperative pain control, and low incidence of early postoperative complications and side-effects are needed. Pacha et al. [11] performed a retrospective study of 109 patients who underwent office PVP for LUTS/BPH. They included patients with a prostate size (weight) between 50 and 115 g, with an average weight of 54.2 g. The average energy was 99 856 J with a range of 17 800– 452 722 J. Uroflow improved from 10 to 14 ml/s. The complication rate was 11.3% and the overall satisfaction was 91% [11]. Osterberg et al. [12 ] performed a retrospective review of office-based PVP in men with LUTS/BPH. Forty-seven patients were selected for office-based PVP by a single surgeon. Any patient with an American Society of Anesthesia (ASA) score of more than 4 was excluded. Any patient with a prostate volume greater than 60 ml was also excluded. Periprostatic analgesia was provided in a standardized transperineal fashion. Two 20-gauge 12-cm disposable spinal needles attached to 20-ml syringes filled with 20 ml of 1% lidocaine were prepared. The injections were performed perpendicular to the skin, approximately 2.5 cm posteromedial to the left or right ischial tuberosity. Under the guidance of the surgeon’s finger, the needle was slowly advanced through the ischiorectal fossa, until it hit the ischial spine. Then it was pushed posteriorly, just anterior to the Alock canal. After confirming the needle tip position is not inside a vein or artery by aspiration, 20 ml of 1% lidocaine was injected. A similar procedure was performed on the contralateral side [12 ]. A transperineal anesthesia block was associated with conscious sedation. All patients underwent conscious sedation. The mean prostate volume was 35.8 ml and the mean lasing time was

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Male lower urinary tract symptoms

19.1 min. A 120-W high-performance system (HPS) GreenLight laser was used for the PVP. The mean total laser energy used was 85 387 kJ. The authors showed that the improvement of the patients’ symptoms and complication rates were comparable to PVP under general anesthesia and in an inpatient setting. Fernando et al. [13] reported significant improvement in LUTS/BPH in a group of patients, with 28% of the patients having prostate volumes greater than 80 ml. None of the patients needed blood transfusion, though 5% developed urosepsis and 9% had clot retention postoperatively [13]. At present, there are limited published data regarding outpatient PVP procedures. Early reports suggest that in patients with good physical status, minimal medical comorbidities, and a prostate volume of less than 60 ml, the outpatient PVP could be an appropriate option.

BIPOLAR PLASMA VAPORIZATION The flow of a high-frequency electric current between two electrodes generates plasma. This plasma can be used for prostate tissue vaporization. Terms used to name this procedure include bipolar vaporization, plasma kinetic vaporization, electrovaporization, TUR in saline (TURis), plasma vaporization, and the ‘Button’ procedure. Bipolar plasma vaporization was thought to lead to less perioperative bleeding. The studies, however, do not support this hypothesis. In a prospective randomized trial, Falahatkar et al. [14 ] compared the outcome of bipolar transurethral vaporization of the prostate (TUVP to that of bipolar TURP). A total of 88 patients with moderate to severe LUTS due to BPH underwent procedures and were evaluated 3 months following operation. There was no significant difference in the number of complications between the two groups, but the TUVP group demonstrated a higher urinary retention. At 3 months’ follow-up, substantial improvements in IPSS and Qmax were noticed in both the groups. A prospective clinical trial compared the modified continuous bipolar plasma vaporization (C-BPVP), standard vaporization (S-BPVP), and monopolar TURP [15 ]. One hundred and eighty LUTS/BPH patients with prostate volume of less than 80 ml and moderate to severe symptoms (according to Qmax, IPSS, Quality of Life (QoL), and PVR) underwent three procedures and were followed for 6 months. The new ESG-400 bipolar generator was employed for C-BPVP as opposed to a first-generation Olympus SurgMaster UES-40 energy source. The operation time for the C-BPVP group was significantly less than both the conventional &&

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and the TURP groups. The risk of complications such as hematuria and catheterization in addition to hospital stay were significantly lower in both the C-BPVP and S-BPVP groups compared with the TURP group. Furthermore, patients in both the C-BPVP and S-BPVP groups experienced better improvement in IPSS and Qmax during follow-up as compared to the TURP group. We were not able to find a study of bipolar plasma vaporization in an outpatient setting.

CONCLUSION Lower urinary tract symptoms due to BPH is a common urological problem in aging men that demands a safe, effective, and durable management strategy. Despite technologic advancement, most ablative prostate therapies are not appropriate for an outpatient setting, whereas nonablative thermotherapy procedures lack durability and efficacy. Technologies such as Urolift may have the opportunity to fill this gap. Some preclinical data regarding intraprostatic injections and prostate heat therapy with water vapor are promising and have the opportunity to be used primarily in an outpatient setting. These technologies will be covered in later sections. Acknowledgements None. Financial support and sponsorship None. Conflicts of interest M. Zangi reported no potential conflicts of interest relevant to this article. S. Tabatabaei worked as a consultant for the American Medical Systems Company.

REFERENCES AND RECOMMENDED READING Papers of particular interest, published within the annual period of review, have been highlighted as: & of special interest && of outstanding interest 1. Irwin DE, Milsom I, Hunskaar S, et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol 2006; 50:1306–1315. 2. Coyne KS, Sexton CC, Thompson CL, et al. The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study. BJU Int 2009; 104:352– 360. 3. Irwin DE, Kopp ZS, Agatep B, et al. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int 2011; 108:1132–1138. 4. Parsons J. Lifestyle factors, benign prostatic hyperplasia, and lower urinary tract symptoms. Curr Opin Urol 2011; 21:1–4. 5. Albertsen PC, Pellissier JM, Lowe FC, et al. Economic analysis of finasteride: a model-based approach using data from the Proscar long-term efficacy and safety study. Clin Ther 1999; 21:1006–1024. 6. Reich O, Gratzke C, Bachmann A, et al. Morbidity, mortality and early outcome of transurethral resection of the prostate: a prospective multicenter evaluation of 10,654 patients. J Urol 2008; 180:246–249.

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Truth of BPH outpatient surgery Tabatabaei and Zangi 7. Madersbacher S, Alivizatos G, Nordling J, et al. EAU 2004 guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction (BPH guidelines). Eur Urol 2004; 46:547–554. 8. Hoffman RM, Monga M, Elliott SP, et al. Microwave thermotherapy for benign prostatic hyperplasia. Cochrane Database Syst Rev 2012; 9; CD004135. 9. Aagaard MF, Niebuhr MH, Jacobsen JD, et al. Transurethral microwave && thermotherapy treatment of chronic urinary retention in patients unsuitable for surgery. Scand J Urol 2014; 48:290–294. This study evaluates more than one decade experience in TUMT for patients unsuitable for gold standard surgical treatment. The study emphasizes the benefit of outpatient hyperthermia therapy through transurethal microwave catheter in the management of patients in urinary retention, with significant medical history. 10. Talab SS, McDougal WS, Wu C-L, et al. KTP laser coagulation of submucosal telangiectatic vessels in patients with radiation-induced cystitis: a novel approach. Urology 2014; 84:478–483. 11. Pacha T, George V, DiLoreto R, Elgin R. 2169 Feasibility, outcomes, and satisfaction in patients with benign prostatic hyperplasia undergoing office photoselective vaporization of the prostate under local anesthesia. J Urol 2012; 187:e875.

12. Osterberg EC, No D, Otto BJ, et al. A retrospective review of office-based 532-nm Greenlight laser prostatectomy in men with symptomatic benign prostatic hyperplasia. Urology 2013; 82:680–685. The study shows the promising outcome of Greenlight laser for BPH patients with favorable ASA score without extremely large prostate size. 13. Fernando A, Emara A, Barber N. The continuous evolution of the Greenlight laser photo-selective vaporisation of the prostate: better outcomes with the XPS System. Urology 2012; 80 (3A):5–6. 14. Falahatkar S, Mokhtari G, Moghaddam KG, et al. Bipolar transurethral && vaporization: a superior procedure in benign prostatic hyperplasia: a prospective randomized comparison with bipolar TURP. Int Br J Urol 2014; 40:346–355. This prospective randomized trial illustrates comparable functional outcomes of bipolar transurethral vaporization and TURP. 15. Geavlete B, Stanescu F, Iacoboaie C, Geavlete P. Bipolar plasma enucleation & of the prostate vs. open prostatectomy in large benign prostatic hyperplasia cases: a medium term, prospective, randomized comparison. BJU Int 2013; 111:793–803. This clinical trial compares the outcome of Button with conventional procedures for patients with large BPH. &&

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benign prostatic hyperplasia: truth or myth?

Worldwide, lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) is a common medical problem for aging men. Of patients who se...
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