==inizio objective==

Patients with Lower Urinary Tract Symptoms (LUTS) due to Benign Prostate Hypertrophy (BPH) frequently have comorbidities related to the cardiovascular system such as arterial hypertension, diabetes, hyperlipidemia and metabolic syndrome (1 – 8). In particular, BPH, causing nocturia- induced sleep disturbance, may have a possible impact on blood pressure variability during night- time (1). Patients with BPH also frequently complain of depression (9, 10), osteoarthritis (11) chronic renal disease (12), erectile dysfunction (2, 4, 7), and diabetes (13) and, finally they are frequently exposed to potentially hypotensive agents such as PDE5-inhibitors (14,15,16).
The pharmacological management of BPH with associated comorbidities is particularly complex with risk of multiple interactions among the different types of treatments (7, 14, 17, 18) and an high likelihood of early discontinuation of therapy; notwithstanding this, the impact of co-medications and comorbidities on therapeutic choice is still to be ascertained (19). In general, the evaluation of comorbidities is considered highly relevant for the management of patients with BPH (20).
1. Objective
The LUTS.COM (Evaluation and management of LUTS associated to BPH in the context of Common COMorbidities) observational study was designed to assess the prevalence of significant comorbidities in male patients attending a visit for LUTS associated with BPH at an outpatient clinical ward.
Moreover, the study aims (i) to describe the medications administered for comorbidities, (ii) to assess the patients’ quality of life patients by means of the nocturia-specific Quality-of-Life (N- QOL) questionnaire administered during the visit, and (iii) to describe the patients’ adherence to the anti-BPH medications as assessed by the Morisky 4-Item Self-Report Measure of Medication Adherence Scale (MMAS-4) (21, 22, 23), administered during the visit, in patients under pharmacologic treatment

==fine objective==

==inizio methodsresults==

The LUTS.COM study is an Italian, observational, multicenter, cross-sectional study endorsed by AURO.it (Associazione Urologi Ospedalieri).
At the enrolment visit, retrospective data such as diagnostic tests, and urological parameters (i.e. plasma levels of PSA, IPSS scores, Qmax, results of digital rectal examination or trans-rectal or suprapubic echographies) were collected up to 3 months earlier; moreover, data regarding comorbidities and pharmacological treatments for significant comorbidities and for LUTS were recorded. We focused on significant medical conditions such as arterial hypertension, known ischemic heart disease, known cerebrovascular disease, known peripheral arterial disease of lower limbs, diabetes mellitus, osteoporosis, major depressive disorder, chronic renal disorder, osteoarthritis, metabolic syndrome, and erectile dysfunction (as reported by patients). The patients’
To be considered as evaluable for the LUTS.COM study, patients had to be aged >= 50 years and present LUTS associated to BPH at enrolment as per clinical judgment. Patients who met the
following exclusion criteria were not considered as evaluable for the analyses: patients who received any investigational compound within 90 days prior to inclusion; patients who were immediate family members, study site employee, or in dependent relationship with a study site employee involved in the study; patients with known contra-indication to the medication prescribed for LUTS; patients who present or refer a known overactive bladder syndrome or prostate cancer.
quality of life was assessed by means of the N-QoL questionnaire. The N-QoL questionnaire (24) specifically measures the effect of nocturia on quality of sleep and consists of 12 items scored from 0 to 4 and one item regarding quality of life. Two sub-scales (sleep/energy and bother/concern) scores and an overall score can be calculated. Higher scores mean better quality of life. Finally, patients’ adherence to the anti-BPH therapies were evaluated by the MMAS-4. The MMAS-4 is a self-reported, medication-taking behavior scale and consists of four questions about the way patients might experience drug errors or omissions. The MMAS-4 score is a non- adherence score ranging from 0 to 4 (21, 22, 23); a higher score means higher adherence to therapy.

==fine methodsresults==

==inizio results==

Patients were consecutively enrolled from December 2014 to December 2015. The LUTS.COM study involved 29 Urology Italian Centers that enrolled 807 male patients. Final statistical analyses are currently ongoing.

==fine results==

==inizio discussions==

Data are not available yet. Statistical analyses will be performed in order to respond to the study objectives.

==fine discussions==

==inizio conclusion==

The management of patients with LUTS due to BPH is strongly influenced by the frequent presence of multiple comorbidities, and so, it is fundamental to have a clear idea of what is the distribution of comorbidities among these patients, in the Italian context. This study will allow to describe comorbidities in Italian patients affected by LUTS suggestive of BPH.

==fine conclusion==

==inizio references==

1. Karatas OF, Bayrak O, Cimentepe E, Unal D. An insidious risk factor for cardiovascular disease: benign prostatic hyperplasia. Int J Cardiol. 2010 Oct 29;144(3):452. doi: 10.1016/j.ijcard.2009.03.099. Epub 2009 Apr 9. PubMed PMID: 19359054.
2. Roehrborn CG, Nuckolls JG, Wei JT, Steers W; BPH Registry and Patient Survey Steering Committee. The benign prostatic hyperplasia registry and patient survey: study design, methods and patient baseline characteristics. BJU Int. 2007 Oct;100(4):813-9. PubMed PMID: 17822462.
3. Muzzonigro G. Tamsulosin in the treatment of LUTS/BPH: an Italian multicentre trial. Arch Ital Urol Androl. 2005 Mar;77(1):13-7. PubMed PMID: 15906783.
4. Li MK, Garcia L, Patron N, Moh LC, Sundram M, Leungwattanakij S, Pripatnanont C, Cheng C, Chi-Wai M, Loi-Cheong N. An Asian multinational prospective observational registry of patients with benign prostatic hyperplasia, with a focus on comorbidities, lower urinary tract symptoms and sexual function. BJU Int. 2008 Jan;101(2):197-202. Epub 2007 Nov 13. PubMed PMID: 18005205. McVary KT: BPH – epidemiology and comorbidities Am J Managed Care 2006, 12, 5 suppl.: S 122-8
5. Sarma AV, Kellogg Parsons J. Diabetes and benign prostatic hyperplasia: emerging clinical connections. Curr Urol Rep. 2009 Jul;10(4):267-75. Review. PubMed PMID: 19570487.
6. Shah M, Butler M, Bramley T, Curtice TG, Fine S. Comparison of health care costs and co-morbidities between men diagnosed with benign prostatic hyperplasia and cardiovascular disease (CVD) and men with CVD alone in a US commercial population. Curr Med Res Opin. 2007 Feb;23(2):417-26. PubMed PMID: 17288695.
7. Hartung R, Matzkin H, Alcaraz A, Emberton M, Harving N, van Moorselaar J, Elhilali M, Vallancien G; ALF-ONE Study Group. Age, comorbidity and hypertensive co-medication do not affect cardiovascular tolerability of 10 mg alfuzosin once daily. J Urol. 2006 Feb;175(2):624-8; discussion 628. PubMed PMID: 16407011.
8. Hartung R, Matzkin H, Alcaraz A, Emberton M, Harving N, van Moorselaar J, Elhilali M, Vallancien G; ALF-ONE Study Group. Age, comorbidity and hypertensive co-medication do not affect cardiovascular tolerability of 10 mg alfuzosin once daily. J Urol. 2006 Feb;175(2):624-8; discussion 628. PubMed PMID: 16407011.
9. Quek KF, Low WY, Razack AH, Loh CS. The psychological effects of treatments for lower urinary tract symptoms. BJU Int. 2000 Oct;86(6):630-3. PubMed PMID: 11069367.
10. Rom M, Schatzl G, Swietek N, Rücklinger E, Kratzik C. Lower urinary tract symptoms and depression. BJU Int. 2012 Dec;110(11 Pt C):E918-21. doi: 10.1111/j.1464-
410X.2012.11552.x. Epub 2012 Oct 26. PubMed PMID: 23107188.
11. Song HJ, Han MA, Kang HC, Park KS, Kim KS, Kim MK, Kang J, Park EO, Hyun MY, Kim CS. Impact of lower urinary tract symptoms and depression on health-related quality of life in older adults. Int Neurourol J. 2012 Sep;16(3):132-8. doi: 10.5213/inj.2012.16.3.132. Epub 2012 Sep 30. PubMed PMID: 23094219; PubMed
Central PMCID: PMC3469832.
12. Hong SK, Lee ST, Jeong SJ, Byun SS, Hong YK, Park DS, Hong JY, Son JH, Kim C,
Jang SH, Lee SE. Chronic kidney disease among men with lower urinary tract symptoms due to benign prostatic hyperplasia. BJU Int. 2010 May;105(10):1424-8. doi: 10.1111/j.1464-410X.2009.08975.x. Epub 2009 Oct 28. PubMed PMID: 19874305.
13. Fourcade RO, Lacoin F, Rouprêt M, Slama A, Le Fur C, Michel E, Sitbon A, Cotté FE. Outcomes and general health-related quality of life among patients medically treated in general daily practice for lower urinary tract symptoms due to benign prostatic hyperplasia. World J Urol. 2012 Jun;30(3):419-26. doi: 10.1007/s00345-011-0756-2. Epub 2011 Sep 3. PubMed PMID: 21892656; PubMed Central PMCID: PMC3360843.
14. White WB, Moon T. Treatment of benign prostatic hyperplasia in hypertensive men. J Clin Hypertens (Greenwich). 2005 Apr;7(4):212-7. Review. PubMed PMID: 15860960.
15. Nieminen T, Kööbi T, Tammela TL, Kähönen M. Hypotensive potential of sildenafil and tamsulosin during orthostasis. Clin Drug Investig. 2006;26(11):667-71. PubMed PMID: 17163302.
16. Kloner RA. Pharmacology and drug interaction effects of the phosphodiesterase 5 inhibitors: focus on alpha-blocker interactions. Am J Cardiol. 2005 Dec 26;96(12B):42M- 46M. Epub 2005 Dec 5. Review. PubMed PMID: 16387566.
17. Schulman CC. Lower urinary tract symptoms/benign prostatic hyperplasia: minimizing morbidity caused by treatment. Urology. 2003 Sep;62(3 Suppl 1):24-33. Review. PubMed PMID: 12957197.
18. O’Leary MP. Treatment and pharmacologic management of BPH in the context of common comorbidities. Am J Manag Care. 2006 Apr;12(5 Suppl):S129-40. Review. PubMed PMID: 16613527.
19. Verhamme KM, Dieleman JP, Bleumink GS, Bosch JL, Stricker BH, Sturkenboom MC. Treatment strategies, patterns of drug use and treatment discontinuation in men with LUTS suggestive of benign prostatic hyperplasia: the Triumph project. Eur Urol. 2003 Nov;44(5):539-45. PubMed PMID: 14572751.
20. Djavan B, Margreiter M, Dianat SS. An algorithm for medical management in male lower urinary tract symptoms. Curr Opin Urol. 2011 Jan;21(1):5-12. doi: 10.1097/MOU.0b013e32834100ef. Review. PubMed PMID: 21045704.
21. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. PubMed PMID: 3945130.
22. Morisky DE, DiMatteo MR. Improving the measurement of self-reported medication nonadherence: response to authors. J Clin Epidemiol. 2011 Mar;64(3):255-7; discussion 258-63. doi: 10.1016/j.jclinepi.2010.09.002. Epub 2010 Dec 8. PubMed PMID: 21144706; PubMed Central PMCID: PMC3109729.
23. Morisky DE, Malotte CK, Choi P, Davidson P, Rigler S, Sugland B, Langer M. A patient education program to improve adherence rates with antituberculosis drug regimens. Health Educ Q. 1990 Fall;17(3):253-67. PubMed PMID: 2228629.
24. Abraham L, Hareendran A, Mills IW, Martin ML, Abrams P, Drake MJ, MacDonagh RP, Noble JG. Development and validation of a quality-of-life measure for men with nocturia. Urology. 2004 Mar;63(3):481-6. PubMed PMID: 15028442.

==fine references==

==inizio objective==

Holmium Laser Enucleation of the prostate (HoLEP) was introduce in 1998 by Peter Gilling with the traditional 3 lobes technique. HoLEP technique diffusion is due to advantages such as the use of saline as irrigation fluid, less hemorrhagic risks than TURP, and can treat any prostate size.
The introduction of more powerful lasers has allowed to treat larger prostate volumes.
Holmium:yttrium-aluminum-garnet (Ho:YAG) lasers doubled their power since the HoLEP was introduced.
Currently there is a lack in scientific literature of evidence in patients benefits and procedure’s outcome due to the increase in laser’s power up to 120 W.
This study compare the efficacy and safety between two Ho:YAG lasers, 120-W and 100-W, in perform HoLEP in patients with lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).

==fine objective==

==inizio methodsresults==

A retrospective multicentric analysis of 120 patients with symptomatic BPH was carried out. Patients were enrolled in two centers, in each center all HoLEP procedures were performed by a single experienced operator. Each center enrolled 60 patients, in particular the first 30 consecutive patients undergone HoLEP with Ho:YAG laser 120-W (Lumenis Pulse 120H) and the last 30 patients undergone HoLEP with Ho:YAG laser 100-W (Lumenis VersaPulse 100W Holmium).
All the HoLEP procedures included in the study were performed with the traditional 3 lobes technique as described by Peter Gilling1. All surgical instruments used during the HoLEP were the same for both groups except for the Ho:YAG laser tools. Patient demographics data, peri-operative outcome and 3-months follow-up data were analyzed with the International Prostate Symptom Score (IPSS), quality of life (QoL) score, maximum flow rate (Qmax), postvoid residual urine volume (PVR), and rates of peri-operative complications

==fine methodsresults==

==inizio results==

Patients in each group showed no significant difference in pre operative parameters. Compared with the 100-W group, patients in the 120-W group required significantly longer time for laser enucleation (p = 0.038).
Mean peri-operative hemoglobin’s decrease in the 120-W HoLEP group was similar to the 100-W group (P > 0.05).
Early incidences of complications not differ significantly between the two groups of 120 W HoLEP and 100-W HoLEP patients (P > 0.05).
At 3 months follow-up, the HoLEP performed with two different Ho:YAG laser compared, did not demonstrate a significant difference in IPSS, QoL score, Qmax, or PVR (P > 0.05).

==fine results==

==inizio discussions==

Operative and laser times are longer in the 120W-Group, those differeces can be attributed to technical modifications in the hemostatic phase; the need to apply the laser directly on the vessel to coagulate.
In 100W-Group hemostasis is performed using the same laser setting used during enucleation (2 Joule, 50 Hz), on the other hand in the 120W-Group enucleation is performed using full power setting (2 Joule, 60 Hz) and hemostasis with a different setting (long pulse 2 Joule, 30 Hz) activated using a dedicated second pedal. The reduction of the laser pulse frequency during the hemostasis and the presence of the new double pedal are new aspects when using the 120 W-Ho:YAG laser to perform HoLEP.
Particularly the new method of laser application during hemostasis and use of the second pedal during hemostasis may have negatively affected the first 30 cases performed with the new 120 W-Ho:YAG laser given the need to change established habits of experienced operators with HoLEP performed with 100W Ho:YAG lasers.

==fine discussions==

==inizio conclusion==

120 Watt HoLEP is safe and effective as HoLEP performed with 100 Watts Ho:YAG laser.
In our study laser’s activation time and HoLEP’s operating time are longer in HoLEPs performed with Ho: YAG laser 120 watts are longer than in the group of HoLEP were performed with 100 watt Ho: YAG laser; more studies are needed to determine whether this is due to transition from the Ho: YAG 100 Watts laser (Lumenis Holmium Versapulse 100W) to the new Ho: YAG laser 120 Watts (Lumenis Pulse 120H) or whether it is due to the laser settings used in the process of hemostasis.

==fine conclusion==

==inizio references==

1- GILLING, P. J., KENNETT, K., DAS, A. K., THOMPSON, D., & FRAUNDORFER, M. R. (1998). Holmium laser enucleation of the prostate (HoLEP) combined with transurethral tissue morcellation: an update on the early clinical experience. Journal of endourology, 12(5), 457-459.
2 – Gupta, N., KUMAR, R., Dogra, P. N., & Seth, A. (2006). Comparison of standard transurethral resection, transurethral vapour resection and holmium laser enucleation of the prostate for managing benign prostatic hyperplasia of> 40 g. BJU international, 97(1), 85-89.
3 – Elzayat, E. A., Habib, E. I., & Elhilali, M. M. (2005). Holmium laser enucleation of the prostate: a size-independent new “gold standard”. Urology, 66(5), 108-113.
4 – Aho, T., & Gilling, P. (2008). Current techniques for laser prostatectomy-PVP and HoLEP. Archivos Españoles de Urología, 61(9), 1005.
5 – Barry M.J., et al. (1992) The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol,148(5): p. 1549-57

==fine references==

==inizio objective==

Granulomatous prostatitis is an unusual, non-specific inflammatory process of the prostate gland, characterized by the presence of granuloma as the main histological feature. It is subclassified as: infectious granuloma, nonspecific granulomatous prostatitis, post-biopsy granuloma, and systemic granulomatous prostatitis. Rare forms of granulomatous prostatitis include sarcoidosis and xanthogranulomatous prostatitis. This form is histologically similar to granulomatous prostatitis, with the prominence of foamy histiocytes, which constitute the xanthomatous component. Non-specific granulomatous prostatitis and xanthogranulomatous prostatitis are likely caused by a blockage of prostatic ducts and stasis of gland secretions. The resulting epithelial disruption leads to the escape of cellular debris, bacterial toxins, prostatic secretions, including corpora amylacea, sperm and semen into the stroma, determining an intense localized inflammatory response. We present a case series of xanthogranulomatous prostatitis in 5 patients that came to our clinic between 2008 and 2014. These patients have a history of hematospermia, progressive lower urinary tract symptoms (LUTS), and increasing levels of serum prostate-specific antigen (PSA).

==fine objective==

==inizio methodsresults==

All patients (mean age 56.8; range: 51–62) came for recurrent episodes of hematospermia (associated with fever in 3 patients), which represented the onset symptom. All men suffered also from LUTS, characterized by urinary frequency, burning, hesitancy, and nocturia. In all patients, a PSA elevation was observed (range: 4.8–6.7 ng/mL), with a normal ratio always greater than 20% (range: 22–36%).3 Digital rectal examination (DRE) revealed an increase in the gland size and a change in the consistency with an irregular surface in all cases. The palpatory findings (peripheral nodule of hard consistency) and the serum PSA level (>4 ng/mL) also confirmed the use of antibiotic therapy and this lead us to suspect malignancy in all cases. As such, the patients had an ultrasound-guided transperineal prostatic biopsy (12 cores) to exclude a malignant diagnosis.

==fine methodsresults==

==inizio results==

All patients were treated for LUTS with medical therapy (alpha-adrenergic blockers plus Serenoa repens), but none reported any significant symptom improvement . For this reason all the subjects were evaluated by transrectal ultrasound examination (TRUS) and urodynamics. TRUS showed a marked inhomogeneity of prostate tissue, with several hypoechoic and hypervascularized areas and calcifications along the peripheral surface of the adenoma, while pressure/flow studies showed the presence of a severe bladder outlet obstruction (BOO). Therefore, all patients underwent transurethral bipolar endoscopic resection of the prostate (TURP). During surgery, the prostate gland tissue appeared white-yellowish and presented no histiocytes significant bleeding. After superficial resection, minimal pus came out from small, occasional abscess pockets. No intra- or postoperative complications occurred. The mean catheterization time was 3 days; one patient had acute urinary retention 48 hours after catheter removal due to inflammatory condition, revealed by DRE. PSA levels significantly decreased and were below 2 ng/mL in all patients. Urinary urgency and burning were the most represented urinary symptoms during the first 2 weeks after surgery; 2 patients required additional antibiotic and anti-inflammatory medication. Histopathological examination of resected prostatic tissue in all patients revealed xanthogranulomatous prostatitis with no evidence of malignancy. A non-specific granulomatous inflammation was found, mainly consisting of plasma cells, lymphocytes, neutrophils, eosinophils, multinucleated giant cells, and epithelioid cells that surrounded, distended or destroyed glandular lumens. The granulomas were composed of multinucleated giant cells and “xanthogranulomatous cells” (diffusely in 4 cases, focally in the fifth).

==fine results==

==inizio discussions==

Xanthogthranulomatous prostatitis is an unusual benign inflammatory process of the prostate gland, first described by Tanner and Mc Donald in 1943. It is a rare subtype of granulomatous prostatitis, sometimes associated with hyperlipidemia. The etiology and pathogenesis are unclear, although some authors suggest a role of glandular ducts obstruction in its pathogenesis. On average, patients usually present around age 60; the range can be from patients in their twenties to the very elderly.
The granulomatous prostatitis, and its rare variant xanthogranulomatous, are poorly defined clinically and features may include irritative LUTS, frequency and burning, pyuria and hematuria sometimes combined with hematospermia. In 20% of cases, granulomatous prostatitis presents with a triad of sudden-onset high fever, symptoms of prostatitis and a nodular painless firm with a prostate enlargement, palpable on DRE. However, as our case series revealed, most patients suffer from a severe BOO, which might exacerbate the chronic inflammatory condition of the prostate; this can help determine the xanthomatous phenomenon inside the gland. According to this hypothesis, as expected, in our case series the complete symptoms relief was achieved only through surgery. Hematospermia as the onset symptom has not been reported so far. Hemospermia has been sporadically reported as an accompanying symptom in very few cases, but only in our case series it represented the uncommon symptom of disease onset. In 40% of all cases reporting hematospermia, an infectious condition is revealed. Other etiologic factors are inflammatory conditions, neoplasms and iatrogenic factors. After confirming the presence of hematospermia, physicians should perform a clinical evaluation, including clinical history and physical examination with DRE.
A PSA level increase is often observed, with a reported rise to 150 ng/mL in 1 case. On rectal examination, the prostate may be hard and nodular mimicking prostate carcinoma, which must be excluded. The transrectal ultrasound and magnetic resonance image cannot distinguish this entity from prostatic malignancy, but generally the ultrasound shows hypoechoic lesions. The final diagnosis can only be achieved by histopathological examination of the prostate. The histological feature of xanthogranulomatous prostatitis is the presence of macrophages with foamy cytoplasm “xanthomatous cells” (CD68+) in the mixed flogistic infiltrate with multi-nucleated giant cells.

==fine discussions==

==inizio conclusion==

In our case series, the hematospermia was always the onset symptom, which was accompanied by severe LUTS secondary to BOO. The histopathologic findings after performing TRUS-guided transperineal biopsy only revealed a non-specific inflammatory process of the peripheral gland. The patients were non-responsive to combined medical therapy, so TURP was performed in all cases. To diagnose the xanthogranulomatous prostatitis, we highlight the importance of histological findings obtained on the specimen of the transitional zone after performing TURP. In addition, the immunohistochemical examination, such as CD68 and PSA, were crucial in getting a definitive diagnosis and in excluding the presence of carcinomatous foci that may be suspected.

==fine conclusion==

==inizio references==

1. Lee HY, Kuo YT, Tsai SY, et al. Xanthogranulomatous prostatitis: a rare entity resembling prostate adenocarcinoma with magnetic resonance image picture. Clin Imaging. 2012;36:858–60.
2. Rafique M, Yaqoob N. Xanthogranulomatous prostatitis: A mimic of carcinoma of prostate. World J Surg Oncol. 2006;4:30.
3. Razek AA, Elhanbly S, Eldeak A. Transrectal ultrasound in patients with hematospermia. J Ultrasound. 2010;13:28–33.
4. Uzoh CC, Uff JS, Okeke AA. Granulomatous prostatitis. BJU Int. 2007;99:510–2.

==fine references==

==inizio objective==

Transurethral resection of the prostate (TURP) is the current standard operation for lower urinary tract symptoms due to benign prostatic obstruction (BPO) in cases of prostates 30-80ml [1]. For larger glands, open simple prostatectomy (OP) is still performed in many urological centers [2]. Transurethral holmium laser enucleation has been popularized over the last decade as an effective alternative to OP [3].
Several types of laser systems are currently used in urological clinical practice for BPO treatment [4]. Among them, thulium YAG (Tm-YAG) has gained attention over the last years, as it is suitable for many different transurethral surgical techniques, including vaporization (ThuVAP), vaporesection (ThuVaRP), vapoenucleation of the prostate (ThuVEP), and bladder neck incision and enucleation defined as ThuLEP [4]. ThuLEP employs the Tm:YAG laser for apical incision of the prostatic tissue down to the surgical capsule. Then, the adenoma is enucleated bluntly with the sheath of the resectoscope, like using the index finger in OP technique [5]. We previously published our initial experience with 148 patients, showing a significant improvement in all outcome parameters [5].
The aim of our study was to compare in terms of efficacy and safety ThuLEP and OP for the treatment of BPO.

==fine objective==

==inizio methodsresults==

Patients with LUTS secondary to BPH treated at our center between March 2010 and July 2014 were deemed eligible for this prospective single center study. Inclusion criteria were: prostate volume >80 ml, maximum urinary flow rate (Qmax) < 15 ml/sec and IPSS >7. Patients with prostate cancer, neurogenic bladder dysfunction, and previous urinary tract surgery or previous pelvic radiotherapy were excluded. There was no upper limit of prostate size. Patients were randomised in a 1.1 ratio with a computer-generated table to ThuLEP (148 patients, group A) and to OP (148 patients, group B).
The time of catheterization was the primary endpoint of this study, as this translates into faster recovery and gained working days. Given a mean catheterization time of 5.4 days for OP, based on in-house audit data as well as data from the literature [2], and assuming 30% reduction in mean catheterization time for ThuLEP, as based on data reported in the meta-analysis by Bach [6].
The catheter was removed when the urine was clear, and the patient was discharged from the hospital only after spontaneous urinary voiding. The decision to remove the catheter was made by two co-investigators who were unaware of the surgical modality used. Secondary outcomes were the operative time, hospital stay, blood loss (indirect measurement through comparison of hemoglobin levels before and 24 hours postoperatively).
All patients were evaluated at baseline and after 12 months follow-up by digital rectal examination (DRE), trans rectal ultrasonography, abdominal ultrasonography. International Prostate Symptoms Score (I-PSS) questionnaire was self-administrated to patients. An International Index of Erectile Functions-5 questionnaire (IIEF-5), was administrated. PSA values were evaluated. Uroflowmetry was performed. Moreover, the following pre and post-operative data were collected: hemoglobin (g/dl), catheter time (days), hospitalization time (days). Every complication occurred during and after the operative procedure was recorded.

==fine methodsresults==

==inizio results==

Patients mean age was 66.3±8.8yo. A better outcome for Group A was detected in terms of blood loss (1.27±0.88 sd VS Group B 3,23 g/dl ± 2,78 sd); mean days of Catheter removal (Group A 2,04 days ± 0,45 sd Vs Group B 6,33 days ± 2,42 sd); mean days of Hospitalization (Group A 2,15 days ± 0,39 sd Vs Group B 6,54 days ± 1,93 sd).
Furthermore in the Group A there was a significant lower rate of complications then Group B. Bladder wall injury during morcellation occurred in the 1.3% of group A patients, and in all cases bladder mucosa only was involved so the injured area could be effectively coagulated with laser fiber at 40 W. Post-operative blood transfusion occurred in the 2.7% of patients. Irritative symptoms, urge incontinence and/or dysuria, occurred in the 6,7% of patients and they lasted for a period of three weeks maximum. Patients who underwent to OP develop as most important complication severe bleeding and 10,8% of them needed blood transfusion. UTI occurred in 6,0% of patients; urinary incontinence (more then 1 pad per day) occurred in the 3,3% of patients, they perform pelvic floor training for incontinence and all achieve social continence (1 pad/day). Clot retention due to severe bleeding occurred in the 5,4%, these patients were treated with a bladder washing. At 12 months follow up there were no statistical significant differences between two groups in terms of mean PSA volume (ng/ml) (Group A 0,93 Vs Group B 0,85); mean Prostate Volume (ml) (Group A 13,76 Vs Group B 11,82); mean I-PSS (Group A 3,90 Vs Group B 4,20); mean Qmax (ml/sec) (Group A 28,67 Vs Group B 27,87); mean PVR (ml) (Group A 12,89 Vs Group B 13,56); mean IIEF-5 score (Group A 20,3 Vs Group B 18,5).

==fine results==

==inizio discussions==

Here in we report the first study comparing ThuLEP to OP in patients with large prostate gland. Our data show that ThuLEP is an effective and safe endoscopic surgical procedure in this patient population. OP has traditionally been the alternative option to TURP for large prostate. Data in literature showed that this procedure is highly successful. In a recent series of 902 patients who underwent OP for prostates of mean size of 96.3 ± 37.4 ml, the overall complication rate was 17.3%. The most relevant complication was bleeding requiring transfusion in 7.5% of patients [2]. As far as ThuLEP was concerned, specific aspects were emphasized as technically relevant. At this purpose, during the enucleation process a close contact between tip of laser fiber and the prostatic capsule was carefully maintained. A rigorous enucleation plane was persistently created, using the resectoscope that bluntly dissects the adenoma on its capsule thus clearly revealing the neat surface and distinctively observable fibres of the capsule. Ultimately, the good visibility thus the low amount of blood loss, the clear identification with consequent coagulation of all perforating vessels of the prostate capsule added to the safety of the morcellation stage.
ThuLEP compared with Open Prostatectomy showed a better clinical and statistically significant outcome in early post-operative. Peri and post-operative bleeding was drastically reduced and this fact is sustained from the lower drop of hemoglobin, comparing ThuLEP and OP and from a mean g/dl of hemoglobin loss of 1,27 Vs 3,27 respectively. The low rate of bleeding with ThuLEP is sustained also comparing the percentage of patients who needed blood transfusion 2,7% Vs 10,8 for ThuLEP and OP respectively. The low rate of bleeding with ThuLEP showed really good ability in hemostasis, and this fact is relevant especially for those patients who need surgery for BPH and who underwent also chronic antiplatelet or anticoagulant therapy because the attitude of Thulium YAG, compared with other laser device, to offer maximum hemostats [5;6;7]. In our opinion, although there are no data confirming this, those patients could go for ThuLEP without interrupting their therapy due to reduce thrombosis risk. [8] Furthermore specific studies and international protocols are needed to confirm this.
Substantial advantaged of ThuLEP compared to OP concern also the days of catheterization (2,04 for Thulep Vs 6,33 for OP) and the days of hospitalization (2,15 for ThuLEP Vs 6,54 for OP). The shorter postoperative recovery is one of main goal of all newly surgical approaches, reducing biological costs like nosocomial infections, and reducing also economical costs.

==fine discussions==

==inizio conclusion==

It should be stressed that ThuLEP is prostate size independent procedure as the same as open prostatectomy for BPH, in fact we treated patients with prostate size between 75 to 210 grams. Some studies showed that there is an increased risk of morbidity when large volume of glands are treated [23], anyhow we did not find any correlation between prostate size and complications rate in patients in Group A.
represents a safe and effective alternative to OP for the treatment of BPO. Minimal blood loss, short hospital stay, short catheterization time, quick recovery, and possibility to treat patients under anticoagulantin therapy represent the main advantages of this novel technique compared to OP.

==fine conclusion==

==inizio references==

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==fine references==