Implant of ATOMS® system for the treatment of postoperative male stress urinary incontinence: an Italian multicentric study.

BACKGROUND: The aim of this study was to evaluate efficacy and safety of the ATOMS system for the treatment of postoperative stress urinary incontinence (SUI). METHODS: We included all consecutive male patients referring for postoperative SUI and treated with ATOMS system from June 2013 to July 2017. Patients received anamnesis, 24 h Pad Test, Pad count, physical examination, urodynamic evaluation, ICIQ-UI SF questionnaire. We excluded patients with low bladder capacity and compliance, uncontrolled detrusor overactivity. RESULTS: We treated 98 patients with median age of 70.21±10.02 years. The most common cause of SUI was open radical prostatectomy in 79 patients. Ten patients had undergone urethrotomy, 7 bladder neck incision, 14 adjuvant radiotherapy. Thirty-nine patients suffered of mild incontinence (24 h Pad Test <200 g), 49 moderate incontinence (200-400 g), 10 severe incontinence (≥400 g). Thirty-one patients underwent previous incontinence surgery: 29 ProACT, 3 artificial urinary sphincters (in 2 cases both devices), 1 bulking agents and subsequent male sling. Median follow-up was 21.5 months. We had a significant reduction of mean 24 h Pads Test, pad count and ICIQ-UI SF questionnaire (P<0.01). At last follow-up 47.96% of patients were dry and 79.59% reached social continence. A high incontinence grade, adjuvant radiotherapy, previous urethral surgery and incontinence surgery have been associated with lower continence results. We had complications in 33 patients (33.7%). The device was removed in 4 cases due to scrotal port erosion and in one case due to persistent pain. CONCLUSIONS: The ATOMS system seems to be an effective and safe surgical treatment for postoperative male SUI.

Efficacy and safety of adjustable balloons (Proact™) to treat male stress urinary incontinence after prostate surgery: Medium and long-term follow-up data of a national multicentric retrospective study.

AIMS: Male stress urinary incontinence (SUI) represents a complication after radical prostatectomy or benign prostatic obstruction surgery. The artificial urinary sphincter is considered the standard treatment but interest on minimally invasive devices, such as adjustable balloons, has recently increased. Aim of this study is to evaluate the efficacy and safety of the ProACT system. METHODS: In this multicentric retrospective study, we reported the data from nine centers. Patients with SUI who underwent a ProACT device implantation for postoperative SUI and had a minimum follow-up of 24 months were included. Efficacy was evaluated at the maximum available follow-up and was assessed utilizing a 24-hour pad test. Patients were considered: "Dry" if presenting a urine leak weight lower than 8 g at the 24-hour pad test; "Improved" if presenting a reduction of urine leak higher than 50% (but >8 g/24 hours); "Failure" if presenting a reduction in urine leak lower than 50%. The evaluation included a record of intraoperative and long-term complications. RESULTS: Safety and efficacy results are reported on 240 patients. 29.6% of patients were dry at 24 months, 37.5% were improved and 32.9% of patients were considered failures. The baseline mean pad weight of 367 g was reduced to 123 g at 24 months. Five-year follow-up on 152 patients showed similar efficacy. The complication rate was 22.5%, with the top complication being long-term balloon failure. CONCLUSIONS: ProACT implantation represents a safe and efficacious treatment for male postoperative SUI at both medium and long-term follow up. 67.1% of patients were dry or improved at 24 months. The majority of complications are low grade.

Intravesical Radiofrequency-Induced Chemohyperthermia for Carcinoma in Situ of the Urinary Bladder: A Retrospective Multicentre Study.

OBJECTIVE: To examine the effect of intravesical radiofrequency-induced chemohyperthermia (RF-CHT) in carcinoma in-situ (CIS) patients overall and split according to previously received therapy. METHODS: CIS patients that underwent an induction and maintenance phase of≥6 RF-CHT instillations, and had either pathology or cystoscopy plus cytology available at 6 months of follow-up were retrospectively included. Complete response (CR), recurrences, cystectomy-free rate, overall survival (OS), and adverse events were evaluated. Analysis was performed for overall, bacillus Calmette-Guérin (BCG)-unresponsive, other BCG-treated, and treatment naïve patients. RESULTS: Patients (n = 150) had a mean of 17.5, 9.2, or 0 previous BCG instillations in the BCG-unresponsive (n = 50), other BCG-treated (n = 46, missing n = 4), and treatment naïve groups (n = 47, missing n = 3), respectively. After 6 months, a CR of 46.0%, 71.7%, and 83.0% was found (p < 0.001). Subsequent 2-year recurrence rates were 17.4%, 27.3%, and 12.8%, respectively. The overall cystectomy-free rate and OS at mean follow-up (35.8 months) were 78.5% and 78.0%, respectively. These were 71.4% vs. 84.1% vs. 86.7% (cystectomy-free rate, p = 0.006) and 76.0% vs. 69.6% vs. 87.2% (OS, p = 0.06) for BCG-unresponsive vs. other BCG-treated vs. treatment naïve patients. Progression to muscle-invasive disease was seen in 13.3% of patients. Patients stopped induction or maintenance RF-CHT instillations due to adverse events in respectively 13.4% and 17.8%. CONCLUSIONS: Intravesical RF-CHT showed good results in both treatment naïve and BCG-treated CIS patients, avoiding the need for cystectomy in 78.5% of cases for at least 3 years with a modest risk of progression. Thus, RF-CHT proves an alternative to cystectomy in selected high-risk patients.

Results of a Randomised Controlled Trial Comparing Intravesical Chemohyperthermia with Mitomycin C Versus Bacillus Calmette-Guérin for Adjuvant Treatment of Patients with Intermediate- and High-risk Non-Muscle-invasive Bladder Cancer.

BACKGROUND: Despite adjuvant intravesical therapy, recurrences in non-muscle-invasive bladder cancer (NMIBC) are still high; therefore, new treatment options are needed. The use of chemohyperthermia (CHT) as an alternative treatment is expanding in Europe. To date, however, there has been a lack of prospective randomised data. OBJECTIVE: To compare CHT using mitomycin C (MMC) with bacillus Calmette-Guérin (BCG) as adjuvant treatment for intermediate- and high-risk NMIBC. DESIGN, SETTING, AND PARTICIPANTS: Between 2002 and 2012, 190 NMIBC patients were randomised in this controlled, open-label, multicentre trial for 1-yr CHT (six weekly treatments and six maintenance treatments) and 1-yr BCG immunotherapy (six weekly treatments and three weekly maintenance treatments at months 3, 6, and 12). Patients and physicians giving the interventions were aware of assignment. This study is registered with ClinicalTrials.gov (NCT00384891). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary end point was 24-mo recurrence-free survival (RFS) in the intention-to-treat (ITT) and per-protocol (PP) analyses in all papillary NMIBC patients (n=147). Analyses were done with the log-rank test and Fisher exact test. All tests were two-sided. RESULTS AND LIMITATIONS: The 24-mo ITT RFS was 78.1% in the CHT group compared with 64.8% in the BCG group (p=0.08). The 24-mo RFS in the PP analysis was 81.8% in the CHT group compared with 64.8% in the BCG group (p=0.02). Progression rates were <2% in both groups. Regarding the side-effects, no new safety concerns were identified. A concern is that this study closed prematurely and thus is underpowered. Furthermore, blinding of treatment for patients and physicians was impossible; this may have resulted in unavoidable bias. CONCLUSIONS: CHT is a safe and effective treatment option in patients with intermediate- and high-risk papillary NMIBC. A significantly higher 24-mo RFS in the CHT group was seen in the PP analysis. Based on the results above, CHT is an option for BCG therapy as adjuvant treatment for intermediate- and high-risk papillary NMIBC. PATIENT SUMMARY: Recurrences in non-muscle-invasive bladder cancer are common, despite adjuvant therapies. We compared 24-mo recurrence-free survival (RFS) with chemohyperthermia (CHT) versus bacillus Calmette-Guérin (BCG) therapy. According to these data, CHT therapy appears to be safe and has higher 24-mo RFS than BCG therapy.

Intravesical mitomycin C combined with local microwave hyperthermia in non-muscle-invasive bladder cancer with increased European Organization for Research and Treatment of Cancer (EORTC) score risk of recurrence and progression.

PURPOSE: To assess the activity of intravesical chemotherapy and local microwave hyperthermia (ICLMH) in increasing the disease-free interval (DFI) in patients with non-muscle-invasive bladder cancer (NMIBC) and treatment toxicity. METHODS: Forty-two patients with a diagnosis of high-risk NMIBC, according to the European Organization for Research and Treatment of Cancer (EORTC) criteria, were treated with an intensive schedule of ICLMH using 40 mg mitomycin C. The treatment consisted of 4 weekly sessions, followed by 6 sessions delivered every 2 weeks, and by 4 monthly sessions, for a total of 14 sessions over 8 months. The DFIs before and after treatment were compared in each patient. RESULTS: The schedule was completed as planned by 32 patients (76.2 %). The percentage of disease-free patients the year before study was 14.9 % (95 % CI 5.5-28.8) versus 88.8 % (95 % CI 73.7-94.8) after ICLMH (p < 0.0001). Patient EORTC scores, multifocality, and tumour stage were all associated significantly and independently with a higher risk of recurrence after ICLMH treatment with HR of 41.1 (p = 0.01), 17.7 (p = 0.02), and 8.5 (p = 0.02), respectively. After a median follow-up of 38 months, 24 patients (57.1 %) did not show evidence of disease, whereas 13 patients (30.9 %) underwent disease recurrence and 5 patients (11.9 %) showed also stage progression. Toxicity consisted in grades 1 and 2 frequency, non-infectious cystitis, and haematuria. CONCLUSIONS: ICLMH significantly increases the DFI of NMIBC patients with high EORTC score for recurrence and progression. Toxicity of the intensive treatment schedule was generally mild.

Prognostic significance of fluorescent in situ hybridisation in the follow-up of non-muscle-invasive bladder cancer.

AIM: To evaluate the potential contribution of a fluorescent in situ hybridization (FISH) as prognostic indicator of the risk of recurrence or progression in patients undergoing follow-up for non-muscle-invasive bladder cancer (NMIBC). PATIENTS AND METHODS: A total of 126 consecutive patients with a history of NMIBC being followed-up with urinary cytology and cystoscopy at a referral centre were studied. Patients with carcinoma in situ, or tumour stage higher than pT1 were excluded. A UroVysion FISH kit was used to detect four chromosomal abnormalities, specifically, locus 9p21, Ch 3, 7, and 17. Three FISH patterns were defined: negative; low-risk positive, i.e. positive staining for 9p21 and/or Ch3 abnormalities; and high-risk positive, i.e. positive staining for Ch7 and/or 17. RESULTS: Overall 73 out of 126 patients (57.9%) had a positive urinary FISH test. After a median time of 14 months, 46 FISH-positive patients underwent recurrence (36.5%) and in 15 patients there was progression of disease (11.9%). Among positive patients, the low-risk category was found in 34, and the high-risk in 39. Low-risk FISH-positive patients had a higher rate of recurrence as compared to FISH-negative patients, with a hazard ratio (HR) of 1.6. The recurrence rate was even greater in patients with a high-risk positive test, with an HR of 1.9. The limitation of the study was that the impact of intravesical treatment was not assessed. CONCLUSION: The urinary FISH test can be used as an aid in predicting the risk of recurrence during follow-up of patients with history of NMIBC.

Short-time ureteral catheterization after operative ureteroscopic lithotripsy: an alternative to stent versus no stent evaluated in a retrospective study.

OBJECTIVES: Stent-less procedure following ureterolithotripsy needs a definition for patient selection and procedure criteria. To mediate stenting versus no stenting, a retrospective study was performed to evaluate the insertion of an ureteral open-tip catheter for 24 hours. MATERIAL AND METHOD: From 2002 to 2006 255 ureterolithotripsy were performed (176 male - 79 female, mean age 51.5 y.o.). Stone was in the upper ureter in 101 cases, in the mid in 89 and the lower in 65. Patients were retrospectively separated into 3 groups: in Group A a stent was placed because of complicated lithotripsy and left for 15 days. In Group B an open-tip catheter was placed for 24 hours. In Group C no catheter was left. All patients were evaluated for symptoms as need of antalgic substances. RESULTS: In Group A 134 patients were stented. The mean stone dimensions were 8.7mm. Flank pain was reported in 52 patients (38%) on post-op 15 days, 77 patients (57.4%) referred lower urinary tract symptoms, 2 patients reported hematuria. In Group B 105 patients (41.1%) were stented with open-tip catheter. The mean stone dimension was 6.3 mm. Pain was referred in 43 patient (40.9%) after the catheter removal. In 12 cases (11.4%) hospital readmission was necessary due to pain. Group C was represented by 16 patients (6.27%). Mean stone dimension was 6mm. No postoperative pain was reported. A statistical difference (p < 0.005) is significative comparing the operative time for the stent vs open-tip group. CONCLUSIONS: No rules establish if it is correct to stent or to avoid this procedure, so trying to resolve the dilemma by inserting an open tip catheter for 24 hours seems a good response. The operating time is reduced for no stenting or positioning catheter vs stenting. To reduce immediate post-ureteroscopy complication placing an open-tip catheter for 24 hours seems to be a simple and cheap procedure.

Current perioperative management of radical cystectomy with intestinal urinary reconstruction for muscle-invasive bladder cancer and reduction of the incidence of postoperative ileus.

Major abdominal surgery, and also radical cystectomy, is followed by a delayed return of bowel function attributable to postoperative ileus (POI), which, in addition, stands out as one of the most frequent complications that causes increased length of stay (LOS). Some variability exists in the definition of POI since time to return of peristalsis and time to first passage of flatus, which are commonly referred to as indicators of bowel activity, have their own weaknesses, observer dependent and time dependent, among other variables. A number of causes have been recognized to induce or maintain the condition of ileus. Some among them are part of the perioperative period. The practices of mechanical bowel preparation (MBP) and of fasting before surgery have been challenged and can be safely abandoned. The perception of pain is an acknowledged promoter of POI; therefore, providing complete pain control constitutes the rationale in favor of administering anesthesia and analgesia combined, both in the form of concurrent general and epidural anesthesia (i.e., at the thoracic level, T9, T11), and represents the mainstay of intraoperative measures. Hypovolemia is also associated with an increased risk of POI. The use of nasogastric tubing (NGT) has been associated with increased pulmonary complications; moreover, bowel resection can be performed safely without postoperative NGT. Early postoperative provision of artificial nutrients has shown beneficial effects, both in the form of total parenteral and enteral nutrition (PEN, EN). We devised a perioperative care regimen, adopting a multimodality approach aimed at minimizing the effects of the above listed factors to ascertain if they could contribute to preventing or reducing POI and the complications associated with radical cystectomy and intestinal urinary diversion. In addition, we investigated the impact of early artificial nutrition, combining PEN and EN via a jejunal nutrition cannula. Time to return of bowel movements, time to reinstitution of a regular diet, presence and duration of POI, and incidence and nature of complications constituted the study end points. Of 143 consecutive patients, 107 who underwent radical cystectomy with intestinal urinary reconstruction were able to be evaluated for results and complications. The male to female ratio was 86:21, the mean age was 74 years, and more than two-third belonged to the American Society of Anesthesiologists categories II and III. Pathologic stages of disease were bladder confined in 48 patients, locally advanced in 33, and extravesical in 26. Urinary diversion with intestine consisted in the configuration of heterotopic reservoirs in 39 patients, orthotopic substitution in 38, and uretero-ileo-cutaneostomy in 30. Bowel movements returned after a median time of 2 days (range, 1-6), and the median time to reinstitution of a regular diet was 4 days (range, 3-9). POI beyond postoperative day 4 was observed in 17.7% of the patients. Overall, a total of 28 patients (26.1%) experienced complications, specifically, medical complications in 19 patients and surgical complications leading to relaparotomy in 11. The mortality rate was 3.7%. No effects were observed on postoperative protein depletion, despite the provision of early artificial nutrition. Our results suggest that a short median time of return of both peristalsis and flatus, and to regular diet resumption with a low incidence of POI, can be obtained in the majority of patients with a perioperative regimen aimed at reducing the effect of some of the causes associated with induction or maintenance of POI. Further studies of multimodality perioperative care plans, similar to that used in the present study, are required.

Short-schedule intravesical gemcitabine with ablative intent in recurrent Ta-T1, G1-G2, low- or intermediate-risk, transitional cell carcinoma of the bladder.

PRIMARY OBJECTIVE: to assess ablative efficacy and tolerability of short-schedule intravesical gemcitabine for intact, low- and intermediate-risk, recurrent superficial bladder tumours. SECONDARY OBJECTIVE: to assess effect on prophylaxis. METHODS: Patients with a diagnosis of recurrence and a history of previous superficial, low- or intermediate-risk bladder tumours were selected for the study. They received 2000 mg gemcitabine in 50 ml, that is 40 mg/ml, intravesically, weekly for 4 wk, followed by resection of any residual lesions. Complete responses consisted of absence of any macroscopic, histologically confirmed, residual lesion, and no response in the presence of residual lesions. The effect on prophylaxis was measured in months as disease-free interval to first recurrence, and as percentage of patients recurring within the first 12 mo. Toxicity was assessed as local and systemic. RESULTS: Of 34 recruited patients, 28 consecutive patients were evaluable, with complete responses observed in 13 of 28 (46.4%) and no response in 15 (53.6%). Median time to first recurrence was 9.1 mo (range: 2.9-26.5) for 19 of 28 (67.8%) patients experiencing recurrence during the first year. Local or systemic toxicity was observed in 9 of 34 (26.4%) patients, resulting in protocol interruption in 6 patients. CONCLUSIONS: Intravesical gemcitabine alone showed ablative efficacy in nearly one half of the patients under study. Drug tolerability was good, both locally and systemically.

Cancer detection with TRUS-guided 10-core biopsy of the prostate. an institutional assessment at the first, repeated and surgical specimen biopsy.

OBJECTIVES: We retrospectively investigated the results of the 10-core scheme that our institute has adopted for three years. The aim of this study is to evaluate the cancer detection rate in different sets of biopsies (first, second, third and surgical specimen biopsy). MATERIAL AND METHODS: Patients with clinical suspicion of prostate cancer based on abnormal digital rectal examination, increase of PSA or hypoechoic lesion at transrectal ultrasound were subjected to a 10-core biopsy. Ten biopsies were taken following the traditional sextant technique and 4 more biopsies were obtained from the lateral peripheral zone. In addition, a group of 19 specimens of retropubic radical prostatectomy were biopsied immediately following surgery. RESULTS: Of 664 patients 247 (37.2%) were positive for prostate cancer at first biopsy. Eighty-one out of 664 patients were subjected to a second biopsy for persistent elevation or increasing of PSA, or in case of tumor associated histological findings such as high PIN and ASAP. The cancer detection rate in this group was 19.8% (16/81). Of the remaining 65 patients who were negative at second biopsy, 12 received a third biopsy for persistent clinical suspect of cancer, and 2 were positive (16.7%). In 19 surgical specimens, 14 biopsies were confirmed positive and 5 were negative (73.7%). CONCLUSIONS: The extended biopsy such as the 10-core scheme showed to be a reliable protocol, taking an adequate cancer detection rate either at first or repeated biopsy with no increase in morbidity.

Results and complications with the mini-laparotomic incision in 52 consecutive radical retropubic prostatectomies.

OBJECTIVES: We describe a simple mono-institutional study to prospectively assess the benefits and complications of the mini-laparotomic incision for radical retropubic prostatectomy with the anatomic approach. METHODS: Radical retropubic prostatectomy with the anatomical approach, as described by Walsh, was performed through a 4 to 8 cm incision. Median operative time, body weight, prostate weight, pathologic stage, incidence of positive surgical margins, urinary continence, the need for post-operative analgesics, peri-operative complications, are the parameters we assessed. Blood losses were calculated with the aid of a specific formula instead of simply recording the suction or weighing the sponges. RESULTS: 52 patients were consecutively operated on through a mini-laparotomic incision. Median incisional length was 8 cm (range 4 to 8 cm). Median operating time was 116 minutes (105-141), calculated blood loss was 1108.797ml, incidence of positive margins was 14%, urinary continence was observed in 48/50 patients (98%), and there was a complication rate of 4/52 (7.6%). CONCLUSION: The results we obtained with the mini-laparotomic incision are comparable to previous reports of the standard incision, also by our group, though with a lower need for postoperative analgesia. They also compare with laparoscopic prostatectomy in the length of time of catheterization and post-operative analgetic consumption.

Intravesical gemcitabine in recurrent superficial bladder carcinoma: preliminary results on ablative efficacy and tolerability.

BACKGROUND: The ablative potential and toxicity of gemcitabine, administered intravesically in low stage and grade superficial transitional cell carcinoma (TCC), were evaluated. PATIENTS AND METHODS: Patients with a history of recurrent Ta-T1, GI-G2 bladder TCC were considered eligible for the study. Gemcitabine was administered intravesically at 40 mg/mL concentration (2000 mg in 50 ml saline) in one weekly instillation for 4 consecutive weeks. Fifteen days after the last instillation, patients were submitted to transurethral resection (TUR). RESULTS: Twenty-six patients were evaluable for toxicity, and 20 were evaluable for response, 6 patients being excluded due to toxicity. A complete response was achieved by 10 out of 20 patients (50%), whereas no response was documented in the remainder. Toxicity leading to treatment interruption was grade 3 in 1 patient and grade 2 in 5 patients. CONCLUSION: Intravesical gemcitabine administered at 40 mg/mL showed the capability of ablating small volume, superficial TCC in 50% of the population under study, with acceptable tolerability.

Effects of a shared protocol between urologists and general practitioners on referral patterns and initial diagnostic management of men with lower urinary tract symptoms in Italy: the Prostate Destination study.

OBJECTIVE: To assess whether adopting a shared protocol between urologists and general practitioners (GPs) might change diagnostic procedures and referral patterns in the management of men with lower urinary tract symptoms (LUTS). SUBJECTS AND METHODS: Forty-five urological centres and 263 GPs in Italy participated in this prospective study. Procedures adopted by GPs for evaluating five consecutive patients (aged > or = 50 years) were compared before (phase 1) and after (phase 2) implementation of the shared protocol. An evidence-based diagnostic algorithm was developed and approved by participating urologists and presented to local GPs at a training session. Protocol modifications were allowed after discussion with GPs. Direct costs of diagnostic procedures carried out before and after implementing the protocol were calculated from the perspective of the national health service. RESULTS: In all, 903 patients were evaluable in phase 1 and 856 in phase 2. Implementation of the protocol did not change referral patterns, with about half the patients being managed entirely by GPs. The use of a digital rectal examination by GPs increased from 32% to 41%, use of transrectal and suprapubic ultrasonography decreased from 33% to 23% and 53% to 44%, respectively, (all P < 0.001) and use of the International Prostate Symptom Score increased from 4.5% to 23.1% (P < 0.001). Overall, protocol-recommended tests were used more frequently, while those not recommended decreased after implementing the protocol. However, overuse of the tests not recommended (i.e. urine culture and free/total prostate specific antigen ratio) remained high. The mean cost per patient of diagnostic procedures ordered by GPs decreased from Euros 71.82 to Euros 61.93, with Euros 9.9 saved for each patient. CONCLUSION: Our intervention failed to decrease the percentage of cases of LUTS being referred to specialists, but was moderately effective in inducing changes in the diagnostic management by GPs that were indicative of increased compliance with best-practice principles, and produced cost savings of 13.8%.

Diagnostic procedures by Italian general practitioners in response to lower urinary tract symptoms in male patients: a prospective study.

BACKGROUND: The aim of this prospective, multicentre, observational study was to evaluate the initial diagnostic procedures for lower urinary tract symptoms (LUTS) carried out by Italian general practitioners (GPs). METHODS: Data were collected from 445 GPs in Italy regarding the initial clinical decisions and diagnostic procedures adopted for the management of 1399 male patients with LUTS aged >or= 50 years. RESULTS: 50.3% of patients were managed by the GP,4.9% were referred to the urologist immediately and 44.8% after carrying out some diagnostic procedures. A digital rectal examination was performed in only one-third of the patients, many of whom were not subsequently referred to the urologist (26.4%). Laboratory tests that are usually recommended (i.e. PSA, urinalysis and serum creatinine) were undertaken in 98.3% of patients, while tests that are generally considered optional (such as flowmetry) were undertaken in up to 64%. Other generally not recommended investigations, such as ultrasonography, were carried out in 77.2%. The mean time to diagnosis was significantly shorter when the urologist was not involved (36.0 days for GP only management vs 51.4 days for immediate referral and vs 43.4 days for delayed referral (p = 0.0003). CONCLUSIONS: Our findings show a propensity for the majority of Italian GPs to deal with LUTS patients in a primary setting without immediate referral to the urologist. In principle, this trend could be beneficial for the patient (i.e. by reducing time to diagnosis) and cost saving for the national health system. However, the diagnostic procedures selected by the GPs were not in line with best evidence practice recommendations. Shared-care protocols involving both GPs and urologists may contribute to better implementation of the guidelines on the management of LUTS and benign prostatic hyperplasia in Italy.