Evaluation of intralesional injection of hyaluronic acid compared with verapamil in Peyronie's disease: preliminary results from a prospective, double-blinded, randomized study.

Several intralesional therapeutic protocols have been proposed for the treatment of Peyronie's disease. Among all, hyaluronic acid (HA) and verapamil have been differently tested. We aimed to evaluate the efficacy of intralesional verapamil (ILVI) compared with intralesional HA in patients with early onset of Peyronie's disease (PD). This is a multi-centre prospective double-arm, randomized, double-blinded study comparing ILVI vs. intralesional HA after 12-weeks. Sexually active men, older than 18 years and affected by the acute phase of PD were eligible for this study. Patients have been double-blinded randomly divided into two groups (1 : 1 ratio): Group A received intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks, while group B received intralesional treatment with HA (0.8% highly purified sodium salt HA 16 mg/2 mL) weekly for 12 weeks. The primary efficacy outcome was the change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree). The secondary outcome was the change in the plaque size and in the International Index of erectile Function (IIEF-5) score. The difference between post- and pre-treatment plaque size was -1.36 mm (SD ± 1.27) for Group A and -1.80 mm (SD ± 2.47) for Group B (p-value = NS). IIEF-5 increased of 1.46 points (SD ± 2.18) in Group A and 1.78 (SD ± 2.48) in Group B (p-value ± NS). No difference in penile curvature was observed in Group A, while in Group B the penile curvature decreased of 4.60° (SD ± 5.63) from the baseline (p < 0.001) and vs. Group A. According to PGI-I results, we found significant difference as concerning patient global impression of improvement (PGI-I) (4.0 vs. 2.0; p < 0.05). This prospective, double-arm, randomized, double-blinded study comparing ILVI vs. HA as intralesional therapy showed greater efficacy of HA in terms of penile curvature and PGI-I.

A simple and cheap system to speed up and to control the tumescent technique procedure: the Tedde's system.

We have devised a low cost system to quickly infiltrate tumescent solution: we call it the "Tedde's system". This low-cost system offers an improvement in quality and quantity of the infiltration because all the procedure depends on the operators, reducing also the time of the infiltration and consequently of the whole surgical procedure. Moreover, this system can be applied to other surgical procedure that requires large infiltration volumes.

Combination of intralesional verapamil and oral antioxidants for Peyronie's disease: a prospective, randomised controlled study.

The aim of this study was to evaluate the efficacy of the association of intralesional verapamil (ILV) injection with oral antioxidants compared with ILV monotherapy in patients with early onset of Peyronie's disease (PD) at 12-week follow-up. Group A (n = 52) received ILV 10 mg weekly for 12 weeks, while group B (n = 53) received ILV 10 mg weekly for 12 weeks + antioxidants orally one tablet once a day for 3 months. The main efficacy outcomes were the change in plaque size (PS), penile curvature (PC), visual analogue score (VAS), IIEF-15 and IIEF-15 subdomains. Both groups showed significant improvement from baseline to week 12 relative to PS and PC, while group B also in IIEF-15 score (mean difference: 5.51, P < 0.01) and VAS (mean difference: -2.71, P < 0.01). No significant differences were observed between both groups in PS and PC. Finally, both groups showed significant increase in orgasmic function (IIEF-OF) and overall satisfaction (IIEF-OS), while group B showed significant improvement also in intercourse satisfaction (IIEF-IS). Significant differences were found relative to IIEF-OF, IIEF-IS, IIEF-OS and VAS scores in the group B compared with group A. Patients affected by PD may benefit from combination treatment with ILV and oral antioxidants thanks to the improvement in IIEF-OF, IIEF-IS and IIEF-OS at 12 weeks.

Expression of CD7, CD20 and CDX-2 in a secondary signet-ring cell tumor of the prostate: a case report.

As is well-known, signet ring cell carcinoma (SRCC) rarely appears as a histological finding in the prostatic tissue. Nevertheless, a differentiation should be made between a primary tumor and a metastatic disease. We describe the case of a 52-year-old man with lower urinary tract symptoms, serum total PSA of 0.2 ng/ml, elevated serum CEA and CA19-9 levels. Two years prior to presentation, he underwent total gastrectomy with histological findings indicating poor differentiated adenocarcinoma with signet-ring cell. A palpable nodule was found on digital rectal examination and for this reason he underwent 12-core transperineal prostate biopsy with a diagnosis of poor differentiated adenocarcinoma with signet-ring cell and adipose tissue infiltration. Immunohistochemical examinations revealed positivity for PAS, CK7 and CDX-2, focal positivity for CK20 and negativity for PSA and PSAP. The diagnosis of a prostatic secondary SRCC was possible given the positivity to CK7, CDX-2, focal positivity to CK20 and negativity to PSA.

Risk factors of sexual dysfunction after transurethral resection of the prostate (TURP): a 12 months follow-up.

The aim of this study was to evaluate the impact of risk factors of erectile dysfunction (ED) after transurethral resection of the prostate (TURP) in men with lower urinary tract symptoms caused by bladder outlet obstruction secondary to benign prostatic hyperplasia. The study was conducted prospectively on 178 consecutive patients (normal IIEF-5 before surgery, ≥ 22) who underwent TURP. Patients were assessed before surgery and at 12 months. At 12 months, the IIEF-5 score significantly decreased from24 to 18 (p<0.0001). No statistical associations were found between hypertension, diabetes, dyslipidemia and capsular perforation and the development of ED after TURP. Operating time, duration of catheterization, and BMI did not determine a significant decrease of the IIEF-5 score after TURP. On univariable and multivariable linear regression analysis, age was the only risk factor associated with newly-reported ED 12 months after TURP (p<0.0001). On univariable andmultivariable logistic regression analysis, patients older than 65 yr had an higher risk of developing ED after TURP (p<0.0001) and they developed a lower IIEF-5 score (p<0.0001) at followup when compared with those ≤ 65 yr. These results suggest that age of patients represents an independent risk factor of ED at 12 months follow-up after TURP.

Treatment of chronic prostatitis/chronic pelvic pain syndrome category IIIA with Serenoa repens plus selenium and lycopene (Profluss) versus S. repens alone: an Italian randomized multicenter-controlled study.

OBJECTIVES: To evaluate the efficacy and safety of Serenoa repens + selenium and lycopene (Profluss) versus S. repens alone for the treatment of category IIIa chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). PATIENTS AND METHODS: 102 patients with IIIa CP/CPPS were enrolled and randomized into two groups each to receive Profluss or S. repens alone for 8 weeks. Evaluation was based on results of the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), IPSS, maximum peak flow rate (MPFR), and PSA measurements at baseline and at weeks 4, 8 and 8 after the end of treatment. The primary endpoint was a >50% reduction in NIH-CPSI score. Secondary endpoints evaluated were MPFR, IPSS, PSA and white blood cell count. RESULTS: No patients withdrew from the study. The mean NIH-CPSI score decreased significantly (p < 0.001) in both groups; we observed a decrease in the total score from 27.45 to 13.27 in group 1 (-51.64%) and from 27.76 to 20.62 in group 2 (-26.06%). IPSS improved significantly (p < 0.001) in both arms, but more in group 1. PSA and white blood cell count decreased significantly (p < 0.007) only in group 1. The MPFR improved more in group 1 (p < 0.005). CONCLUSION: Profluss is a triple therapy that is safe and well tolerated. It ameliorates symptoms associated with IIIa CP/CPPS.

A case of prostatic rhabdomyosarcoma in childhood.

▪ ABSTRACT: : Rhabdomyosarcoma of the prostate is rare, especially in childhood. The treatment of this neoplasm has been destructive surgery with adjuvant chemotherapy or radiotherapy. These treatment recommendations have been revised to suggest conservative surgery plus adjuvant chemotherapy and radiotherapy. We report treatment of prostatic rhabdomyosarcoma in a child with a long-term follow-up. ▪.

Anxiety disorders among African-American and white primary medical care patients.

The prevalence of current anxiety disorders and associated clinical patterns was examined in a sample of 125 African American and 120 white primary medical care patients between ages 18 and 64. Patients who indicated they had at least one mood or anxiety symptom in response to a screening questionnaire were interviewed to determine the presence of a DSM-IV anxiety, mood, or possible alcohol abuse disorder. Demographic data and data on mental- and physical-health-related functioning and health service utilization were also collected. The authors found no racial differences in the proportions of patients who met DSM-IV criteria for the disorders, nor in their symptom patterns, level of functional disability, or rates of health and mental health service utilization.

The 'usual care' of major depression in primary care practice.

OBJECTIVE: To determine how primary care physicians treat patients with major depression in the course of routine practice and the degree to which such practice produces outcomes anticipated with interventions recommended by the Agency for Health Care Policy and Research Depression Guideline Panel. DESIGNS: Prospective cohort study. SETTINGS: Academically affiliated ambulatory family practice centers and internal medicine clinics in urban neighborhoods of Pittsburgh, Pa. PATIENTS: Ninety-two patients who were seen in primary care practices and who met criteria for a current major depression as determined by the Diagnostic Interview Schedule and a psychiatrist's assessment. INTERVENTION: Physicians were informed of the patient's psychiatric diagnosis, and were urged to treat it in whatever manner and for whatever duration they deemed appropriate (ie, with "usual care"). MAIN OUTCOME MEASURES: The treatments that were provided, the patients' clinical course, and the relationship between the type of treatment and clinical course. RESULTS: Health center records indicated that 67 patients (73%) received a depression-specific treatment in the 8 months following study entry. A majority of the total cohort were prescribed an antidepressant drug. Of the 92 patients, 18 (20%) were asymptomatic at 8 months (Hamilton Rating Scale for Depression score, < or = 7). The treatment pattern was not clearly related to the clinical course. CONCLUSIONS: The recovery rates for the patients with major depression who were treated with usual care in routine primary care practices were lower than those anticipated from treatments consistent with the Agency for Health Care Policy and Research guidelines. Further studies of the caregiving elements that influence the effectiveness of depression-specific treatments of patients in primary care settings are needed.

Treating depressed primary care patients improves their physical, mental, and social functioning.

BACKGROUND: This study describes the functioning of primary care patients with major depressive disorder, the relationship of medical comorbidity to functional status, and the effects of depression-specific treatment on functional status after 8 months. METHODS: Patients were randomized to a protocol intervention (nortriptyline hydrochloride or interpersonal psychotherapy) or to usual care with the patient's physician in a clinical trial of primary care treatments of depression. Their functional status was evaluated using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) and the Global Assessment Scale. Medical comorbidity was assessed with the Duke Severity of Illness Checklist. The Hamilton Rating Scale for Depression and Beck Depression Inventory were used to measure depressive severity. Assessments were conducted at baseline and at 1, 2, 4, and 8 months after randomization. RESULTS: At baseline, patients reported substantial impairments in the functional domains as assessed by the SF-36 and Global Assessment Scale. Severity of general medical illness and depression were not correlated. Greater medical comorbidity was associated with diminished physical, but not psychological, functioning. Mean scores on SF-36 scales and the Global Assessment Scale improved significantly during the 8 months of follow-up. Patients assigned to protocol treatments showed greater improvement, compared with those assigned to usual care, on the SF-36 mental summary scale and most individual scales but not on the SF-36 physical summary scale. However, patients who completed protocol treatment also experienced significant improvement on the physical summary scale. Medical comorbidity was only a weak predictor of outcome. CONCLUSIONS: Primary care patients with major depressive disorder report substantial impairments in physical, psychological, and social functioning on initial assessment. Severity of baseline medical comorbidity did not correlate with severity of depression and only weakly correlated with functional status at 8 months. Functional impairments improve with time, but standardized depression-specific treatment is associated with greater improvement in more domains of functioning than is a physician's usual care.

Clinical presentations of major depression by African Americans and whites in primary medical care practice.

This study compared the psychiatric history and presenting clinical characteristics of 119 African American and 153 white patients assessed for and participating in a randomized control trial of treatments for major depression in primary care practice. African Americans and whites participated equally in the assessment process, and both groups presented with similar psychiatric treatment histories, severity of depression, level of psychosocial functioning, and severity of medical illness. However, racial differences were evident in the comorbidity of psychiatric disorders, severity of somatic symptoms, self-reported physical functioning, life stress, and health beliefs. Implications for the recognition of depression in African American primary care patients are discussed.

Treatment outcomes for primary care patients with major depression and lifetime anxiety disorders.

OBJECTIVE: Major depression occurs with generalized anxiety disorder and panic disorder in up to 60% of psychiatric and primary care patients. This comorbidity has been associated with greater severity of depression, poorer psychosocial functioning, and poorer treatment outcomes in psychiatric samples. This study examined the clinical outcomes for depressed primary care patients with and without a lifetime anxiety disorder. METHOD: A total of 157 primary care patients who met criteria for major depression were randomly assigned to standardized interpersonal psychotherapy or pharmacotherapy with nortriptyline and were assessed at baseline and at 4 and 8 months on severity of depression, psychosocial functioning, and health-related functioning. RESULTS: Depressed patients with a comorbid anxiety disorder presented with significantly more psychopathology and tended to prematurely terminate treatment more frequently than patients with major depression alone. Both standardized depression-specific treatments were effective for depressed patients with and without a comorbid generalized anxiety disorder, although time to recovery was longer for the former. Patients with lifetime panic disorder showed poor recovery in response to psychotherapy or pharmacotherapy. CONCLUSIONS: Standardized psychotherapy and pharmacotherapy are effective for patients with major depression with and without a generalized anxiety disorder. However, the longer time to recovery for the former group and lack of response to these treatments by patients with lifetime panic disorder suggest that primary care physicians should carefully assess history of anxiety disorder among depressed patients so as to select a proper intervention.

Treating major depression in primary care practice. Eight-month clinical outcomes.

BACKGROUND: We studied whether standardized treatments of major depression whose efficacy was established with psychiatric patients are equally effective when provided to primary care patients, and whether standardized treatments are more effective than a primary care physician's usual care. METHODS: A randomized controlled trial was conducted, in which primary care patients meeting DSM-III-R criteria for a current major depression were assigned to nortriptyline (n = 91) or interpersonal psychotherapy (n = 93) provided within well-structured parameters, or a physician's usual care (n = 92). The main outcome measures were degree and rate of improvement in severity of depressive symptoms and proportion of patients recovered at 8 months. RESULTS: Severity of depressive symptoms was reduced more rapidly and more effectively among patients randomized to pharmacotherapy or psychotherapy than among patients assigned to a physician's usual care. Among treatment completers, approximately 70% of patients participating in the full pharmacotherapy or psychotherapy protocol but only 20% of usual care patients were judged as recovered at 8 months. CONCLUSIONS: Pharmacotherapy and psychotherapy effectively treat major depression among primary care patients when provided within specific parameters and for the full acute and continuation phases. Treatment principles recommended by the Depression Guideline Panel of the Agency for Health Care Policy and Research are supported.

Major depression in primary care practice. Clinical characteristics and treatment implications.

Major depression is thought to be underdiagnosed and undertreated in primary medical care facilities. The authors conducted a clinical trial that included a three-phase assessment so only ambulatory medical patients judged eligible for treatment of this disorder in medical settings were recruited. In addition to administering the Center for Epidemiologic Studies-Depression scale and the Diagnostic Interview Schedule's (DIS) Depression section, the psychiatrists evaluated the DIS-positive patients. This third assessment determined that clinical characteristics of DIS-positive patients were such that 70% of the patients could be treated for major depression in a primary care setting, 13% should probably be referred to a mental health facility, and 17% were experiencing conditions other than major depression.

Applicability of clinical pharmacotherapy guidelines for major depression in primary care settings.

OBJECTIVE: To determine whether guidelines established for pharmacologic treatment of major depression are feasible in primary care. DESIGN: Prospective cohort study. SETTING: Ambulatory family health centers and internal medicine clinics. PATIENTS: Ninety-one primary care patients meeting criteria within the Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition for a current major depression randomized to receive antidepressant medication after being judged by a psychiatrist as clinically eligible for pharmacotherapy in an ambulatory setting. INTERVENTION: Nortriptyline hydrochloride prescribed by primary care physicians trained in clinical guidelines specifying dosage schedules, durations, and procedures resembling those recommended by the AHCPR (Agency for Health Care Policy and Research) Depression Guideline Panel. MAIN OUTCOME MEASURES: Patient participation and continuation in medication treatment. RESULTS: Fifty-five percent of patients completed the acute phase of treatment after a mean of 6.9 visits extending over a mean of 8.1 weeks. Of those patients entering the continuation phase, 60% completed the follow-up visits for 6 months. Taken together, only 33% of patients assigned to receive antidepressant medication completed the full regimen recommended by the AHCPR guidelines. CONCLUSIONS: The treatment of depressed primary care patients within AHCPR guidelines for antidepressant medication is feasible but complex. Although primary care physicians ably adhere to these guidelines, keeping patients in treatment is difficult and possibly requires greater flexibility in treatment regimens.

Clinical trials of primary care treatments for major depression: issues in design, recruitment and treatment.

The objective of this article is to consider whether randomized clinical trials (RCTs) are able to determine the validity of transferring treatments for major depression from the psychiatric to the primary care sector. This clinical issue is of growing concern in the United States since both governmental and professional bodies are establishing guidelines for the treatment of medical patients with the affective disorder. The article's method involves analysis of how the competing aims of rigorous scientific methodology (internal validity) and generalization of study findings (external validity) are best balanced within the RCT. Experiences in recruiting medical patients with major depression and providing pharmacologic, psychotherapeutic, and usual care interventions compatible with the sociotechnical characteristics of ambulatory medical centers are described to illustrate the complexities of investigating transferability of treatments for major depression with RCT methodology.

Dose of fluphenazine, familial expressed emotion, and outcome in schizophrenia. Results of a two-year controlled study.

Issues regarding the side effects of antipsychotic medication and the possible contribution of the environment to dose requirements led to a two-year controlled dosage study of maintenance antipsychotic medication and familial environment among recently discharged schizophrenic patients. Seventy stable patients, living in high- or low-expressed emotion (EE) households, were randomized, double blind, to receive a standard dose of fluphenazine decanoate (average, 25 mg every two weeks) or a minimal dose representing 20% of the dose prescribed (average, 3.8 mg every two weeks). No differences in relapse were observed among dose, EE, or dose and EE. Patients in the minimal dose/high-EE condition experienced more minor but aborted episodes in year 2. Side effects were fewer on the minimal dose after one year, and low-EE patients were better adjusted than high-EE patients. Over time, minimal-dose recipients were significantly more improved in their instrumental and interpersonal role performance than were standard-dose recipients.

Family psychoeducation, social skills training, and maintenance chemotherapy in the aftercare treatment of schizophrenia. I. One-year effects of a controlled study on relapse and expressed emotion.

Relapse rates averaging 41% in the first year after discharge among schizophrenic patients receiving maintenance neuroleptic treatment led to the development of two disorder-relevant treatments: a patient-centered behavioral treatment and a psychoeducational family treatment. Following hospital admission, 103 patients residing in high expressed emotion (EE) households who met Research Diagnostic Criteria for schizophrenia or schizoaffective disorder were randomly assigned to a two-year aftercare study of family treatment and medication, social skills training and medication, their combination, or a drug-treated condition. First-year relapse rates among those exposed to treatment demonstrate a main effect for family treatment (19%), a main effect for social skills training (20%), and an additive effect for the combined conditions (0%) relative to controls (41%). Effects are explained, in part, by the absence of relapse in any household that changed from high to low EE. Only the combination of treatment sustains a remission in households that remain high in EE. Continuing study, however, suggests a delay of relapse rather than prevention.