3-month formulation of goserelin acetate ('Zoladex' 10.8-mg depot) in advanced prostate cancer: results from an Italian, open, multicenter trial.

OBJECTIVES: To determine the endocrine effects, efficacy and tolerability of the 3-month formulation of goserelin acetate ('Zoladex' 10.8-mg depot; 'Zoladex' is a trade mark of the AstraZeneca group of companies) in the treatment of patients with advanced prostate cancer. METHODS: Between February 1996 and October 1997, this open, multicentre study enrolled 120 patients with locally advanced (T3/4) or metastatic (N+ or M1) disease, or an increase in prostate-specific antigen (PSA) level after radical prostatectomy. Patients received goserelin acetate 10.8-mg depot every 12 weeks until clinical progression or interruption for adverse events or other reasons. RESULTS: The mean testosterone concentrations were suppressed to the castration range (< or =2 nmol/l) after 4 weeks of treatment and remained suppressed throughout the study. In total, 99/115 (86%) patients had a serum PSA response, and the mean PSA value decreased significantly during treatment (p = 0.006). The mean PSA level at baseline was significantly lower in patients without disease progression compared to those who experienced disease progression (p = 0.0002). Goserelin acetate 10.8-mg depot was well tolerated and there were no injection site reactions. CONCLUSIONS: The goserelin acetate 10.8-mg depot is well tolerated with no injection site reactions. It produces PSA responses and provides reliable suppression of serum testosterone.

[Study of the diuretic efficacy and tolerability of therapy with Rocchetta mineral water in patients with recurrent calcium kidney stones]. / Studio sulla tollerabilità e l'efficacia diuretica della idropinoterapia con acqua oligominerale Rocchetta in pazienti con nefrolitiasi calcica recidivante.

The diluition of urine decreases the risk of stone formation by lowering the concentration of calcium, oxalate and uric acid, but involves a simultaneous decrease of the concentration of the inhibitors of crystallization. On the other hand the ion content of the drinking water used for stone prevention could by itself modify urine composition. We tested the effect of the administration of a mild-calcium high-bicarbonate content water on urine composition of a group of calcium renal stone formers. A group of 40 calcium renal stone formers was instructed to drink 3 l/day of a mild-calcium (57 mg/l) and high-bicarbonate (180 mg/l) content water (Rocchetta) for a 7 day period. A 24-h collection was obtained before and after water administration for analyses of calcium, magnesium, oxalate and citrate. Urine volume was significantly increased after water administration (1601 +/- 357 vs 1878 +/- 339). Daily urinary calcium, magnesium and citrate were significantly increased, whereas daily urinary oxalate was unchanged after water administration. In conclusion the mild-calcium high-bicarbonate content water administration seems suitable for stone prevention because of the increased excretion of urinary inhibitors counterbalancing increased urinary calcium excretion.

Transurethral electrovaporization of the prostate vs. transurethral resection. Results of a multicentric, randomized clinical study on 150 patients.

AIM OF THE STUDY: To evaluate clinical, urodynamic efficacy and safety of TURP and TVP in patients with symptoms due to obstructive benign prostatic hypertrophy with a prospective multicentric randomized study. MATERIALS AND METHODS: 150 patients with BPH, urodynamically obstructed, were randomized to receive TURP or TVP. At the end of the recruitment phase, 80 patients underwent TURP and 70 patients underwent TVP. Patients were clinically evaluated by the I-PSS score at months 0, 1, 3, 6 and 12. Preoperative evaluation included complete blood routine examination, PSA, transrectal ultrasound and pressure/flow studies. Pressure/flow studies were also performed after 3 months. RESULTS: There was no statistical difference between groups in any of the preoperative parameters. All patients were considered urodynamically obstructed at preoperative pressure studies. As for catheter days and hospitalization days, statistical differences between TVP and TURP were found; catheter days were 2.71 days (SE 0.12) in the TURP group vs. 1.9 (SE 0.24) in the TVP group (p < 0.000). Hospitalization was 4.7 days (SE 0.22) after TURP and 3.9 days (SE 0.24) after TVP (p < 0.000). Mean preoperative I-PSS score was 18.84 and 18.19 in the TVP and TURP groups, respectively. At 3, 6 and 12 months, IPSS was 5.52 and 5.50, 3.77 and 4.94, 3.52 and 4.04 for TURP and TVP, respectively. Mean preoperative peak flow rate (PFR) was 8.78 and 7.26 ml/s for TURP and TVP, respectively; after 3, 6 and 12 months, PFR was 19.21 and 18.8, 20.77 and 20.13, 20.30 and 20.31 ml/s, respectively. After 3 months, 6 patients in the TURP group (7.5%) and 7 patients in the TVP group (10%) were borderline obstructed. 1 patient in the TVP group (1.4%) was still obstructed and underwent TURP. As for complications, 4 patients (5.7%) in the TVP group had stress urinary incontinence after 12 months vs. 1 (1.25%) in the TURP group. DISCUSSION: The present study clearly demonstrates that TVP is as effective as TURP in relieving urinary obstruction due to BPH, it offers some advantages in terms of catheterization and hospital stay, but at the price of a higher incidence of postoperative urine incontinence. Technical improvements might solve this problem in the future, perhaps combining TVP with TURP of the apical tissue.

[Iontophoresis in the conservative treatment of Peyronie's disease: preliminary experience]. / La iontoforesi nel trattamento conservativo della malattia di La Peyronie: esperienza preliminare.

In Peyronie's disease an early "peri-vasculitic" phase and a late "sclerogenic" one are described. In the former, conservative management is believed useful; unfortunately it is empirical concerning treatment modalities, drugs and administration routes, due to the poor pathogenetic knowledge of the disease itself. The Authors report on a preliminary experience based on iontophoresis, that is the drugs' ions direct transport from a solution into the tissues by means of a local electric field. 15 patients (47 to 64 years old, mean 55) all with penile recurvatum due to a well (physically and U.S.) documented Peyronie's plaque, and all but one with normal stiffness during erection, were submitted to the following therapeutic schedule: 3 sessions a week for three weeks; in each session (20 minutes) 10 mg verapamil and 4 mg dexamethasone are administered; the iontophoretic equipment delivers a 3 mA current; the active electrode, shaped as a small cup is placed on the penile skin above the plaque; the other electrode is set on one thigh. At a mean 5 months follow up (3-10 months) penile pain during erection disappeared in 66% patients, recurvatum diminished in 53%, and the plaque was reduced in size and/or was softened in 40% of the cases. No patient worsened nor became impotent during the treatment. The contextual improvement of all three above mentioned parameters (pain-recurvatum-physical examination) was observed in 26% of patients (versus 13% in a previous series treated by the Authors by drug peri-plaque injections). Although a longer follow up is necessary before drawing conclusions about the iontophoretic approach to the Peyronie's disease, the Authors wish to stress two main advantages of this therapeutic modality: absence of pain; absence of local trauma, in order to avoid local sclerogenic stimuli, which could perpetuate the hardening process.

[Cellular proliferation, expression of p53, EGFR and apoptosis index of healthy mucosa of the bladder with TCC; pre- and post-intravesical BCG immunohistochemical study]. / Proliferazione cellulare, espressione di p53, EGFR ed indice di apoptosi nella mucosa sana di vesciche con TCC; studio immunoistochimico pre e post BCG endovescicale.

At present, the most efficacious and used immunostimulant agent in the superficial bladder cancer immunotherapy field, is the BCG, even if its mechanism of action is still partly unknown. The therapeutic effects of BCG don't seem to depend exclusively on local immune response, so that according to this assertion, this immunohistochemical study had been conducted on 14 patients affected by superficial bladder cancer (pTa-pT1) which aimed to value both the apoptosis and proliferation indexes and the expression of the genetic product p53 and EGFR before and after the exposition of the vesical mucosa to the BCG. The BCG treatment can reduce the proliferation index of the normal urothelial cells in a statistically significant way whereas it would exclude a cytostatic effect mediate by negative modulation of EGFR from the cytokinins induced by BCG itself. The index of apoptosis of the urothelium does not increase after BCG and decreased expression of p53 associated after the treatment, although statistically not significant, it would seem to bear, the prophylactic efficacy of BCG according to the follow up of the patients included in the study.

[Management of sexual disorders in the diabetic patient. Considerations on diagnosis and therapy based on current pathogenetic and physiopathologic knowledge]. / La gestione dei disturbi sessuali nel diabetico. Considerazioni in tema di diagnosi e terapia alla luce delle attuali conoscenze patogenetiche e fisiopatologiche.

The sexual disorders in the diabetic males are quite frequent, particularly the erectil failures, which involve about 50% of these subjects. After a brief epidemiological note, the Authors review the recent advances about the pathogenesis of such a disturbance in the International Literature: values and limitations of up-to-date diagnostic examinations as well as therapeutic options are critically considered. From the diagnostic point of view the progress of the techniques involved both in the study of penile microcirculation and in the neurophysiopathology of the pelvic autonomic nervous system must be emphasized. Furthermore the great efficacy (up to 90% of satisfactory results) of vasoactive intracorporeal injections has to be stressed.

Late effects of intravesical bacillus Calmette-Guérin immunotherapy on bladder mucosa infiltrating lymphocytes: an immunohistochemical study.

During intravesical bacillus Calmette-Guérin (BCG) treatment for the prophylaxis of recurrent superficial bladder carcinoma, patients typically show a local inflammatory response involving mainly T lymphocytes, most of which have the helper-induced phenotype (CD4+) (CD4+/CD8+ ratio > 1). To evaluate whether this immunophenotypic profile of the lymphocytes persists also after the completion of this immunotherapy, we examined bladder biopsy specimens during the posttreatment follow-up period of 24 patients, previously submitted to a 2-year BCG administration. The intensity of inflammatory response differed among the patients and in 10 of them even between the scar and the normal mucosa of the bladder. A reversal to the pretreatment CD4+/CD8+ ratio < 1 occurred in the majority of subjects, including the 3 patients with histologically confirmed tumour recurrence. In addition, 11 tumour-free patients showed prevailing CD4+ cells in the scar mucosa and prevailing CD8+ in the normal mucosa of their bladder or vice versa. From these findings it appears that the long-term host response to BCG does not depend exclusively on an intense, long-lasting local mononuclear immune reaction.

[Usefulness of PSA density (PSAD) in the differential diagnosis between prostatic adenocarcinoma and benign ++ prostatic hypertrophy]. / Utilità della PSA density (PSAD) nella diagnosi differenziale tra adenocarcinoma prostatico ed ipertrofia prostatica benigna.

The purpose of this study was to evaluate the usefulness of PSAD in distinguishing benign prostatic hyperplasia (BPH) from prostate cancer. The Authors studied 50 patients, 30 affected with BPH and 20 with prostate cancer. All patients were submitted to: digital rectal examination, trans-rectal ultrasonography and evaluation of serum PSA, before performing any prostatic manipulation. All clinical data were confirmed by histological diagnosis. Although the mean PSAD value was greater significantly in the patients' group affected with prostate cancer, it was impossible to define a PSAD cut off value useful to distinguish malignant from benign prostatic diseases. Similar findings have been observed in a sub-group patients with serum PSA concentration of 3.5-15 ng/ml. The PSAD cut off value of 0.10, proposed from some Authors, showed low specificity. On the contrary a cut off value of 0.15 is not sufficiently sensitive: an elevated number of cancer would have missed using this parameter alone. Therefore, the combined use of clinical findings and serum PSA is recommended to improve the early diagnosis of prostate cancer.

[Doppler velocimetry]. / La velocimetria Doppler.

After a brief historical introduction, the Authors describe the methodology of the continuous wave basic and dynamic Doppler examination of the penile arteries as well as the main normal and pathologic patterns. Some special tensiometric tests are reported. Advantages and limits of the afore mentioned examinations are discussed.

[Vesico-urethral and entero-urethral anastomosis: anatomo-surgical considerations and technical note]. / Anastomosi vescico-uretrali ed entero-uretrali: considerazioni anatomo-chirurgiche e note di tecnica.

Following radical prostatectomy or radical cystectomy with orthotopic ileal bladder (in male patients), the cervico-urethral or entero-urethral anastomosis are at high risk for urinary stress incontinence, due to the shortening of the urethral functional length as well as "unavoidable downward fall" of the perineum after sectioning of the anterior portion of the sacro-pubic ligaments. That descensus of the perineum, if uncorrected, might cause a functional extraabdominal positioning of the residual functional urethra; this feature is close similar to one of the most important pathogenetic factors of genuine stress incontinence in the female. In order to correct that perineal fall is advisable to perform the so-called "secondary sphincter" (after Rocca Rossetti, 1982) by suturing with the same stitches not only the anastomotic edges but the medial part of the levator ani (i.d. pubo-rectal muscles) and the retro-urethral striated musculature as well; this technique ensure a good intraabdominal position of the residual functional urethra and prevents dangerous tensions on the anastomosis. The Authors stress the importance of a delicate dissection of the prostatic apex with no or minimal manipulation of the membranous urethra avoiding to evaginate it from the surrounding pelvic floor, that could damage its vascular supply. Following the before mentioned criteria the Authors performed 17 radical prostatectomies and 7 ileal bladder after radical cystectomy with satisfactory results (4.1% of postoperative urinary incontinence).

[Radical prostatectomy: role of ultrasonography in the follow-up]. / Prostatovesciculectomia radicale: ruolo dell'ecografia nel follow-up.

After a brief summary about surgical technique of radical prostatectomy and its indications in the different stages of prostatic cancer, the Authors describe complications and surgical sequelae of this operation. The Authors report a brief series. It is composed with 13 patients. Their have been submitted to radical prostatectomy for prostatic cancer between January 1989 and September 1991. Pathological stage was B1 in 6 patients, B2 in 2 patients, C1 in 4 cases and C2 in 1. Particularly the role of ultrasonography in detection and follow-up of early complications such as lymphocele, pelvic hematoma and anastomotic urine leakage is stressed. Transrectal ultrasound is especially useful in the detection of urine leakage from vesico-urethral anastomosis. This technique is compared with traditional cystourethrography and advantages and disadvantages of the two techniques are discussed. Later complications of radical prostatectomy are anastomotic stenosis, pelvic recurrences, nodal or parenchymal metastasis, urinary incontinence. The role of transrectal ultrasound in the detection of anastomotic strictures is stressed, especially when the study is done during micturition. Transrectal ultrasound is not so satisfying in the detection of pelvic recurrences, especially if they are smaller than 1 cm. In case of large masses digital examination is diagnostic itself. At last the Authors describe urinary incontinence and its etiology as a complication of radical prostatectomy. Particularly a surgical technique for vesico-urethral anastomosis proposed by Rocca Rossetti and its value in post-operative continence is described. The Authors show the results of transrectal ultrasound in the detection of striated urethral sphincter and its function after radical prostatectomy.

A model to assess the risk of recurrences of superficial bladder carcinoma. A preliminary report based on 27 patients with a two-year follow-up.

Being able to identify patients with superficial bladder carcinoma at high risk of tumour relapse would be helpful in reducing the high recurrence rate observed in these cases, because a more aggressive prophylactic treatment could be applied. We obtained a series of cystoscopic and histological findings from 27 patients with pTa and pT1 bladder carcinomas, of whom 19 recurred within 2 years following transurethral resection. Histological grade, shape and number of tumours were chosen as discriminating features between patients who relapsed and those who did not. These three variables were used to derive a discriminant function which classified correctly 23 out of the 27 patients on the basis of their actual situation of tumour relapse at 2 years. This method might therefore prove to be useful in predicting accurately the outcome of each patient, thus allowing us to follow an individualized protocol of surveillance and treatment based on a quantified risk for tumour recurrence.

Immunophenotypic characterization of the bladder mucosa infiltrating lymphocytes after intravesical BCG treatment for superficial bladder carcinoma.

The lymphocytes infiltrating the bladder mucosa of 28 patients treated with bacillus Calmette-Guérin (BCG) for superficial bladder carcinoma were characterized using an immunohistochemical technique on frozen sections of biopsy specimens obtained during cystoscopy. The inflammatory response induced by BCG consisted mainly of T lymphocytes (CD3+), most of which had the helper/inducer phenotype (CD4+), with a CD4/CD8 ratio greater than 1. A minor subset of lymphocytes were of B phenotype (CD22+). These findings persisted for the whole follow-up period (6-12 months) in spite of a progressive decrease of the inflammatory infiltrate. No difference in the lymphocyte phenotype was observed between nonresponding patients and those who responded to BCG in the short term. It is concluded that, although intravesical BCG therapy does affect the immunocompetent cells of the bladder wall, the BCG-induced antitumor activity is unlikely to depend exclusively on a local immune mechanism.

Aztreonam monotherapy as prophylaxis in transurethral resection of the prostate: a multicenter study.

The efficacy and safety of aztreonam in the prophylaxis of urinary tract infection following transurethral resection of the prostate (TURP) in patients with preoperatively sterile urine were studied in a multicenter trial including 300 patients at six Italian urology centers. The present report describes the first 192 patients enrolled in the protocol. Aztreonam or placebo was administered to each patient in three doses, which were given at the induction of anesthesia and 8 and 16 hours later. The development of bacteriuria was monitored by cultures of urine obtained before surgery, 3 days later, at removal of the bladder catheter, at discharge from the hospital, and at a follow-up visit 39-46 days after surgery. A febrile peak was observed for 6% of aztreonam-treated patients and for 20.9% of the placebo group (P less than .005), while bacteriuria was reported in 17.9% and 59.3% of these groups, respectively (P less than .001). From our data, TURP appears to be a clean-contaminated procedure requiring antibiotic prophylaxis, and aztreonam appears to reduce significantly the incidence of postoperative bacteriuria after this surgical procedure.

[Mono-symptomatic hematuria: first symptom of metastatic pulmonary carcinoma]. / Ematuria monosintomatica: primo sintomo di carcinoma polmonare metastatico.

The occurrence of secondary bladder neoplasms is very uncommon, especially when the bladder is the only site of metastasis. The Authors report on one case of bladder metastasis from primary small cell carcinoma of the lung.

[Cystic nephroma: report of two cases and review of literature]. / Nefroma cistico: nostra esperienza su due casi e revisione della letteratura.

Cystic nephroma is an uncommon lesion, whose etiology and pathogenesis is still debated: some Authors designate it as being of neoplastic origin, other ones of dysplastic or hamartomous origin. Also epidemiology makes difficult its pathogenetic interpretation, as being especially affected children under age of fourth year and adults within the 5th and 6th decade. The Authors report two cases of cystic nephroma examined in two female patients 30 and 74 aged. The most interesting matters are: 1) Possibility of a pre-operative diagnosis of founded suspicion, based on pathologic criteria, codified in literature (unilateral and multilocular cyst which doesn't communicate with the renal collecting system, separated by delicate septae without mature renal tissue) and on respective ultrasonographic, CT and angiographic patterns; 2) Possibility of programming a surgical-conservative strategy; 3) Knowledge about possibility of foci association of adeno-carcinoma or nephroblastoma in the lesion, that, nevertheless, if not widespread, it should not modified neither therapeutical proceeding nor prognosis, generally favourable.

[Inverted papilloma associated with transitional cell carcinoma in the upper urinary tract: report of one case and review of the literature]. / Associazione di papilloma invertito e carcinoma uroteliale nell'alta via escretrice: presentazione di un caso e revisione della letteratura.

Inverted papilloma of the pelvis and the ureter is a rather uncommon (only 40 cases in the relevant literature) benign epithelial tumor, occasionally harboring foci of malignancy. Since it does not metastasize, a conservative treatment is advisable, but a strict follow up is always required. The Authors report a case of inverted papilloma of the ureter near which an area of transitional carcinoma was discovered.

[Extrinsic ureteral endometriosis: description of a case]. / Endometriosi ureterale estrinseca: descrizione di un caso.

After a brief review about pathogenetic hypothesis of the endometriosis of the ureter, the Authors describe a case occurred to their observation. Diagnostic problems and choice in treatment (especially partial ureterectomy, end-to-end ureteral anastomosis and omentoplasty) are discussed.