Water vapor therapy (Rezum) for lower urinary tract symptoms related to benign prostatic hyperplasia: early results from the first Italian multicentric study.

PURPOSE: Rezum is the latest developed minimally invasive treatment for benign prostatic hyperplasia (BPH). We aimed to carefully assess the functional outcomes of patients treated with Rezum for BPH. METHODS: We prospectively followed 135 consecutive patients treated by Rezum at 5 institutions from June 2019 to August 2020. The International Prostate Symptom Score (IPSS), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI SF), the Overactive Bladder Questionnaire-Short Form (OAB-q SF) score, the International Index of Erectile Function (IIEF-5) and questions 9 and 10 to assess ejaculatory dysfunction were recorded. Election criteria were age > 18, no prior prostate interventions, IPSS ≥ 13, post-void residual ≤ 250 mL, prostate volume between 30 and 120 cc. RESULTS: The median operative time was 10.5 (IQR 8.7-15) min. All patients were dismissed few hours after surgery with indwelling urinary catheter that was removed after a median of 7 (IQR 7-10) days. A significantly decrease of IPSS from baseline at first (p = 0.001) and third (p < 0.0001) month after surgery was reported. No difference was reported in terms of ICIQ-UI SF score postoperatively. A mild reduction of the OAB-q SF score was reported at 1 month from surgery (p = 0.06) that turned significant at 3 months postoperatively (p < 0.0001). A slight but statistically significant increase of the IIEF-5 score was reported from baseline at 6 months (p = 0.04). Postoperatively, patients reported a significantly decrease of ejaculatory dysfunction after alpha-blocker interruption. CONCLUSION: Rezum treatment is a feasible minimally invasive option for patients with BPH symptoms and showed optimal early functional outcomes.

Evaluación de la biopsia de fusión elástica vs. biopsia sistemática para la detección del cáncer de próstata: resultados de un estudio multicéntrico en 1.119 pacientes / Elastic fusion biopsy versus systematic biopsy for prostate cancer detection: Results of a multicentric study on 1.119 patients

Objetivos: Evaluar la precisión de las biopsias guiada y sistemática para la detección del cáncer de próstata (CP) y CP clínicamente significativo (CPCS) en la práctica diaria, analizando el requerimiento de biopsias sistemáticas adicionales en el momento de la biopsia guiada. Pacientes y métodos: De nuestra base de datos multicéntrica que incluye 2.115 pacientes sometidos a biopsia de fusión con el sistema Koelis(TM) entre 2010 y 2017, seleccionamos 1.119 pacientes que recibieron biopsias guiadas (una mediana de 3 por cada lesión), con posterior muestreo sistemático (12 a 14 núcleos). Se evaluó la tasa de detección de cáncer (TDC) global y clínicamente significativa de las biopsias de fusión de Koelis(TM), comparando la biopsia guiada con la sistemática. Como objetivo secundario, está la identificación de los predictores de detección de CP. Resultados: La TDC de la biopsia guiada fue del 48% para todos los tipos de cáncer y del 33% para el CPCS. El muestreo de próstata sistemático adicional mejoró la TDC global en un 15% y en un 12% para CPCS. Se detectó CP en el 35, 69 y 92% de los pacientes con lesiones calificadas como PI-RADS 3, 4 y 5, respectivamente. Una puntuación elevada de PI-RADS y un examen rectal digital positivo fueron factores predictores de CP, y la condición «biopsia naïve» se asoció con CPCS. Conclusión: En la práctica diaria, la biopsia guiada con Koelis(TM) logra una buena TDC para todos los CP y CPCS, y mejora significativamente con el muestreo sistemático posterior de la próstata. Los excelentes resultados de la biopsia por fusión se confirman también en pacientes naïve. La puntuación PI-RADS elevada y el examen rectal digital positivo están altamente asociados con la presencia de CP

Objectives: To assess the accuracy of targeted and systematic biopsies for the detection of prostate cancer (PCa) and clinically significant PCa (csPCa) in the everyday practice, evaluating the need for additional systematic biopsies at the time of targeted biopsy. Patients and methods: From our multicentric database gathering data on 2,115 patients who underwent fusion biopsy with Koelis(TM) system between 2010 and 2017, we selected 1,119 patients who received targeted biopsies (a median of 3 for each target), followed by systematic sampling of the prostate (12 to 14 cores). Overall and clinically significant cancer detection rate (CDR) of Koelis(TM) fusion biopsies were assessed, comparing target and systematic biopsies. Secondary endpoint was the identification of predictors of PCa detection. Results: The CDR of targeted biopsies only was 48% for all cancers and 33% for csPCa. The performance of additional, systematic prostate sampling improved the CDR of 15% for all cancers and of 12% for csPCa. PCa was detected in 35%, 69%, and 92% of patients with lesions scored as PI-RADS 3, 4 and 5, respectively. Elevated PI-RADS score and positive digital rectal examination were predictors of PCa, whereas biopsy-naïve status was associated with csPCa. Conclusion: In the everyday practice target biopsy with Koelis(TM) achieves a good CDR for all PCa and csPCa, which is significantly improved by subsequent systematic sampling of the prostate. The outstanding outcomes of fusion biopsy are confirmed also in biopsy-naïve patients. Elevated PI-RADS score and positive digital rectal examination are strongly associated with presence of PCa

Elastic fusion biopsy versus systematic biopsy for prostate cancer detection: Results of a multicentric study on 1,119 patients. / Evaluación de la biopsia de fusión elástica vs. biopsia sistemática para la detección del cáncer de próstata: resultados de un estudio multicéntrico en 1.119 pacientes.

OBJECTIVES: To assess the accuracy of targeted and systematic biopsies for the detection of prostate cancer (PCa) and clinically significant PCa (csPCa) in the everyday practice, evaluating the need for additional systematic biopsies at the time of targeted biopsy. PATIENTS AND METHODS: From our multicentric database gathering data on 2,115 patients who underwent fusion biopsy with Koelis™ system between 2010 and 2017, we selected 1,119 patients who received targeted biopsies (a median of 3 for each target), followed by systematic sampling of the prostate (12 to 14 cores). Overall and clinically significant cancer detection rate (CDR) of Koelis™ fusion biopsies were assessed, comparing target and systematic biopsies. Secondary endpoint was the identification of predictors of PCa detection. RESULTS: The CDR of targeted biopsies only was 48% for all cancers and 33% for csPCa. The performance of additional, systematic prostate sampling improved the CDR of 15% for all cancers and of 12% for csPCa. PCa was detected in 35%, 69%, and 92% of patients with lesions scored as PI-RADS 3, 4 and 5, respectively. Elevated PI-RADS score and positive digital rectal examination were predictors of PCa, whereas biopsy-naïve status was associated with csPCa. CONCLUSION: In the everyday practice target biopsy with Koelis™ achieves a good CDR for all PCa and csPCa, which is significantly improved by subsequent systematic sampling of the prostate. The outstanding outcomes of fusion biopsy are confirmed also in biopsy-naïve patients. Elevated PI-RADS score and positive digital rectal examination are strongly associated with presence of PCa.

A multicentric study on accurate grading of prostate cancer with systematic and MRI/US fusion targeted biopsies: comparison with final histopathology after radical prostatectomy.

OBJECTIVE: To evaluate the accuracy in histologic grading of MRI/US image fusion biopsy by comparing histopathology between systematic biopsies (SB), targeted biopsies (TB) and the combination of both (SB + TB) with the final histopathologic outcomes of radical prostatectomy specimens. MATERIALS AND METHODS: Retrospective, multicentric study of 443 patients who underwent SB and TB using MRI/US fusion technique (Urostation® and Trinity®) prior to radical prostatectomy between 2010 and 2017. Cochran's Q test and McNemar test were conducted as a post hoc test. Uni-multivariable analyses were performed on several clinic-pathological variables to analyze factors predicting histopathological concordance for targeted biopsies. RESULTS: Concordance in ISUP (International Society of Urological Pathology) grade between SB, TB and SB + TB with final histopathology was 49.4%, 51.2%, and 63.2% for overall prostate cancer and 41.2%, 48.3%, and 56.7% for significant prostate cancer (ISUP grade ≥ 2), respectively. Significant difference in terms of concordance, downgrading and upgrading was found between SB and TB (ISUP grade ≥ 2 only), SB and SB + TB, TB and SB + TB (overall ISUP grade and ISUP grade ≥ 2) (p < 0.001). Total number of cores and previous biopsies were significant independent predictive factors for concordance with TB technique. CONCLUSION: In this retrospective study, combination of SB and TB significantly increased concordance with final histopathology despite a limited additional number of cores needed.

Y-neobladder: an easy, fast, and reliable procedure.

OBJECTIVES: To describe the operative technique of a new, Y-shaped, ileal neobladder and report the clinical and functional outcomes to add a contribution to the most discussed issues about orthotopic neobladders, in particular related to the problem of the prevention of strictures of ureteral-neobladder anastomoses. METHODS: Between January 1999 and June 2002, 50 patients (41 men and 9 women) underwent radical cystectomy and Y-shaped orthotopic neobladder reconstruction. The following parameters were considered: operative time, complications, and functional outcomes (evaluated with voiding chart and a questionnaire analyzing continence). Urodynamic studies were performed in the first 20 patients. RESULTS: The operative time for neobladder reconstruction was 15 to 20 minutes. No severe complications or significant metabolic complications were recorded. Only 1 case of unilateral stricture of the ureteral-neobladder anastomosis was recorded (1% of renal units); the stricture was easily treated with a retrograde endoscopic approach. Daytime and nighttime continence was good or satisfactory in 90% and 85% of patients, respectively. One year after surgery, the average maximal neobladder capacity was 390 mL, and the average pressure at maximal capacity was 15 cm H2O. CONCLUSIONS: The ileal Y-shaped orthotopic neobladder had good functional outcomes comparable to most popular orthotopic neobladders. Moreover, the surgical technique of the Y-neobladder is easy, rapid, and reliable. In particular, the Y-neobladder seemed to reduce, in our experience, the occurrence of strictures at the ureteral-neobladder anastomosis, because it permits a perfectly aligned anastomosis without mobilization of the ureters.

Incidence of skeletal complications in patients with bone metastatic prostate cancer and hormone refractory disease: predictive role of bone resorption and formation markers evaluated at baseline.

PURPOSE: We evaluated the incidence of skeletal complications in patients with bone metastatic prostate cancer and hormone refractory disease. We also assessed the predictive role of bone turnover markers determined at baseline. MATERIALS AND METHODS: A total of 112 patients were consecutively enrolled in our study from July 1990 to July 1998 and followed until death or the last followup. Bone pain, disease extent in bone, serum prostate specific antigen, hemoglobin, and a panel of bone formation and resorption markers were assessed at baseline before any second line treatment. RESULTS: Skeletal complications in 34 patients (30.3%, estimated yearly incidence 12.3%) involved vertebral deformity or collapse requiring spinal orthosis in 20 (17.9%), spinal cord compression in 7 (6.2%), pathological bone fracture in 10 (8.9%), symptomatic hypercalcemia in 1 (0.9%) and symptomatic hypocalcemia in 1 (0.9%). Median time to the evidence of the initial skeletal complication was 9.5 months. These adverse events did not influence overall survival. At baseline patients with eventual skeletal complications had greater bone pain (p = 0.02), a heavier tumor load in bone (p = 0.005), lower performance status (p = 0.05), and higher serum alkaline phosphatase (p <0.02) and urinary deoxypyridoline (p <0.05) than their counterparts. Multivariate analysis revealed that only urinary deoxypyridinoline was independently associated with the onset of these events (p <0.02). The scatterplot of urinary deoxypyridinoline values in patients with and without skeletal complications enabled us to detect a cutoff of 38 pM./mM. for predicting 51% of skeletal events with only an 8% false-positive rate. CONCLUSIONS: Skeletal complications are common in patients with prostate cancer and hormone refractory disease. Bone loss is the major cause of onset. Baseline deoxypyridinoline at the cutoff point noted had moderate sensitivity but high specificity for predicting these adverse skeletal events.

[Chemotherapy: its repercussions on fertility and potency]. / Chemioterapia: sue ripercussioni sulla fertilità e sulla potenza sessuale.

In the past twenty years, combined therapeutic regimens have improved the survival rare in many human tumors. Chemotherapy plays a significant role on this outcome. Unfortunately, many chemotherapeutic agents have adverse effects on gonadal function. The Authors examine the pathophysiology of gonadal damage in male diagnosed with cancer and treated with chemotherapeutic agents. Infertility and/or impotence can occur on these patients: the relationships between chemotherapy and tumors, towards seminal and sexual dysfunctions, are focused. Moreover, current possibilities to preserve recovery both fertility and sexual functions and discussed.

Changes in free and free-to-total prostate specific antigen after androgen deprivation or chemotherapy in patients with advanced prostate cancer.

PURPOSE: To provide preliminary data on whether the diagnostic role of serum prostate specific antigen (PSA) in assessing the response to treatment is improved by concomitant free PSA evaluation both markers were evaluated in 42 patients with advanced prostate cancer who received hormonal therapy and 57 with hormone refractory disease who received chemotherapy. MATERIALS AND METHODS: PSA was assessed at baseline and every 3 months during treatment. Free PSA was assessed in stored serum samples obtained at baseline and at maximum PSA decrease. Free PSA was not measurable in 17 patients who received androgen deprivation (40.5%) and 2 who received chemotherapy (3.5%) because it was less than 1.5 ng./ml. RESULTS: Of the 21 patients with greater than 50% PSA decrease after hormonal therapy free-to-total PSA increased in 12 (57.2%) and decreased in 9 (42.9%). Of the 20 patients with PSA response after chemotherapy free-to-total PSA increased in 18 (90.0%) and decreased in 2 (10.0%). Free-to-total PSA increased in 12 of the 20 patients (60.0%) with PSA stabilization after chemotherapy. Patients with an increase in free-to-total PSA after chemotherapy had greater survival compared to those with a decrease or no change (19.8 versus 15.5 months, respectively, p <0.03). CONCLUSIONS: These data suggest that an effective cytotoxic regimen mainly affects the protein bound PSA fraction. The absence of a clear predominant pattern of free-to-total PSA in patients with PSA response to hormonal therapy and the high percentage of hormone sensitive patients in whom free PSA was not assessable at maximum PSA decrease suggest that free PSA evaluation is less useful in prostate cancer patients undergoing androgen deprivation.

Randomized comparison of goserelin acetate versus mitomycin C plus goserelin acetate in previously untreated prostate cancer patients with bone metastases.

In a prospective trial conducted by the Gruppo Onco Urologico Piemontese, newly diagnosed prostate cancer patients with bone metastases were randomized to receive goserelin (3.6 mg subcutaneously every 4 weeks) or goserelin plus mitomycin at 14 mg/m2 i.v. every 6 weeks. Treatment was planned to be continued until progression. The study was interrupted because of inadequate accrual rate when 63 patients had been recruited. A long-term follow-up (median, 47 months), performed to counterbalance the limited number of patients included, revealed no difference in time to progression and overall survival between the study treatments. However, 56.5% of assessable patients allocated to the chemotherapy arm presented a > or =90% reduction of prostate-specific antigen levels compared with 36.3% in the goserelin group, and previously elevated levels normalized in 73.9% versus 45.4%. Non-progressing patients received 5-7 cycles of mitomycin C with acceptable toxicity, but the cytotoxic treatment was interrupted early in all cases within the first year due to cumulative myelotoxicity. In conclusion, the results, although inconclusive, fail to support a clear advantage in terms of cost/benefit of chemotherapy plus hormone therapy over hormone treatment alone in advanced prostate cancer with bone involvement.

Pamidronate administration improves the secondary hyperparathyroidism due to "Bone Hunger Syndrome" in a patient with osteoblastic metastases from prostate cancer.

BACKGROUND: The so-called Bone Hunger Syndrome is a metabolic derangement that sometimes complicates the natural history of prostate cancer patients with osteoblastic bone metastases. An excessive bone formation leads to calcium entrapment in bone and the subsequent increase of parathyroid hormone (PTH) levels, in response to calcium demand. PTH elevation stimulates the osteoclasts in sites distant from those involving the tumor, leading to osteomalacia. METHODS: PTH and markers of bone turnover were monitored every 3 weeks, from the start of pamidronate treatment in a prostate cancer patient with progressive disease, to luteinizing hormone releasing hormone analog (LHRH-A) administration, developing hyperparathyroidism, hypophosphatemia, and albumin corrected serum calcium close to the lower limit of normality. Serum bone alkaline phosphatase (BALP), assessed by two different methods: electrophoretic and immunoradiometric, and urinary levels of markers of bone collagen breakdown were also remarkably elevated. RESULTS: As a consequence of pamidronate infusion (60 mg e.v. every 3 weeks for a total of four times), BALP and PTH decreased consistently, serum calcium and phosphorus returned within the normal range, while markers of collagen resorption showed a significant decrease at the 9th week, preceded by a transient rise. CONCLUSIONS: This case report indicates that bisphosphonates could inhibit both osteoclast activity. The anti-osteoblastic effect is mainly responsible for the improvement of the pretreatment calcium imbalance of our patient towards hypocalcemia and the consequent hyperparathyroidism.

Osteoblastic flare assessed by serum alkaline phosphatase activity is an index of short duration of response in prostate cancer patients with bone metastases submitted to systemic therapy.Gruppo Onco Urologico Piemontese (G.O.U.P).

A transient rise in serum alkaline phosphatase (ALP) activity (ALP flare) after androgen deprivation in prostate cancer patients with bone metastases has been previously correlated with both response to therapy and poor prognosis. In the present study we analyzed data coming from an Italian multicenter phase III, trial aimed to compare the efficacy of treatment with goserelin alone with that of goserelin plus mitomycin C. Sixty-seven bone metastatic patients were enrolled: 32 were treated with goserelin and 35 with and goserelin plus mitomycin. 58 cases had ALP measured every month; and were considered for flare assessment. Remarkably elevated ALP and PSA levels at baseline were significantly correlated with poor prognosis. The addition of mitomycin to goserelin resulted in a greater percent reduction of PSA values with respect to goserelin alone but did not augment the time to progression and overall survival. The monthly profile of ALP serum levels was superimposable in patients assigned to hormone therapy or chemotherapy plus hormone therapy. Patients showing a flare in ALP activity (transient rise > 15% in ALP values with respect to baseline at the first month) were classified as responders to therapy or as having stable disease upon PSA evaluation and/or at bone pain assessment, but had a shorter time to progression (median 12 months) in comparison to those showing a different ALP pattern (median 23 months). The measurement of flare in ALP activity during androgen suppression with or without concomitant mitomycin administration, may permit the early identification of patients who are likely to progress rapidly, and hence be candidate for more aggressive treatments.

[Transvaginal ultrasonography in the diagnosis of urethral diverticula]. / L'échographie endovaginale dans le diagnostic des diverticules urétraux.

The authors report their experience on transvaginal ultrasound in the diagnosis of urethral diverticula, using a high frequency linear probe, that is generally employed for transrectal prostate sonography. This non invasive method seems to be more reliable than voiding cystourethrography. This investigation may be recommended in women who have symptoms of lower urinary tract infection, urethral pain, dyspareunia, palpable mass of the anterior vaginal wall.

Monoclonal antibody Ki-67 in the study of the proliferative activity of bladder carcinoma.

We studied the proliferative activity of bladder carcinoma using monoclonal antibody Ki-67, which is able to stain a nuclear antigen exclusively present in cells in the cell cycle, that is with activated deoxyribonucleic acid (DNA). We used this immunohistochemical technique on neoplastic tissue removed by transurethral resection from 101 patients. A significant correlation was observed (p less than 0.003) between cells with activated DNA and histological grading, even though within the context of each grade we observed tumors with a different proliferation index. Furthermore, we studied the location of the activated cells in the context of the tumor. In invasive tumors (stages T1 to T4) cells with activated DNA were always present at the base of implant of the tumor and in the neoplastic tissue that infiltrates the bladder wall. In regard to noninvasive tumors (stage Ta), in 57% of the cases most cells with activated DNA were present in the vegetative portion of the tumor and there were no recurrences at followup, while in 43% of the cases such cells were present also or especially at the base of implant of the tumor, near the lamina propria. In the latter patients we observed a 94% recurrence rate. These results suggest that the immunohistochemical assessment of the proliferative activity of transitional tumors of the bladder, using monoclonal antibody Ki-67, and the evaluation of the location of stained neoplastic cells provide a more reliable estimate of biological aggressiveness than that obtained with histopathological patterns alone.

[Drugs, impotence and infertility]. / Droga, impotenza ed infertilità.

The Authors report the results of a study on 87 patients; among them some were drug dependent and others were already drug-free. This study has in object the consequences of some drugs use (psycoanaleptics, psycoleptics, psychodysleptics) in the sexual behavior and male fertility. Abuse of these drugs seems to be able to cause impotence by psychologic and organic factors. As it concerns the drugs effects on male fertility, we have observed O.T.A. during the dependence period, that seems to be reversible after detoxification. Our purpose is to further investigate the andrological aspects of drug dependence.

[Reliability of transrectal echography in the early diagnosis of prostatic carcinoma: our experience]. / Affidabilità dell'ecografia trans-rettale nella diagnosi precoce del carcinoma prostatico: nostra esperienza.

The Authors observed a group of 20 patients, each of them suffering from prostatic carcinoma clinically localized in only one lobe. All patients were investigated by trans-rectal US tomography, performed with a 5 MHz linear sound, and by prostatic biopsy in both lobes. The Authors evaluate US tomography results in comparison with biopsy executed on the apparently normal lobe and appreciable sensibility, specificity and predictive capability of this method. The Authors believe that trans-rectal US tomography, after having considered sensitivity and specificity values is not to propose as a screening method for early diagnosis of prostatic carcinoma.

[Indications for correction of varicocele]. / Indicazioni alla correzione del varicocele.

In this paper are indicated the procedures to correct the varicocele, based on both the experience of the Authors and the data from the literature. In prepubertal subjects only varicoceles of II and III grade should be operated, meanwhile the I grade can be followed up because it can improve spontaneously. In young people, the asymptomatic varicocele diagnosed incidentally, for instance when people are controlled for military duty, should be operated in order to avoid possible dyspermic troubles. Infertile Adults with varicocele should be always surgically treated but which have either contemporary elevated serum FSH values or different untreated infertility causes. The age limits between which a varicocele can be successfully treated, in order to improve the infertility, are not yet precisely identified. Patients over 35 years are unlikely to recover fertility after operation.

[Use of the monoclonal antibody KI-67 in the study of the proliferative activity of urologic tumors. Preliminary data]. / L'emploi de l'anticorps monoclonal KI-67 dans l'étude de l'activité proliférative des tumeurs urologiques. Données préliminaires.

The authors report the preliminary data of a study on the proliferative activity in urologic cancers. They use the monoclonal antibody KI-67 which can find out a nuclear antigen present only in cells in proliferative phase. They describe the methodology and report the results concerning 12 cancers of the kidney, 17 of the bladder, 17 of the prostate and 2 of the testicle. The most interesting results were obtained in the study of bladder cancer where they could pick out, in the context of the cancers with grading G2, a sub-group with proliferative characteristics similar to those of cancers G3 and vice-versa. They also obtained important results in the study of prostate cancer in hormonal therapy, as they could demonstrate the disappearance of the proliferative activity in patients responding clinically to the treatment.