Giovanni A Tommaselli

University of Naples Federico II, Napoli, Campania, Italy

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Publications (65)157.27 Total impact

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    ABSTRACT: Single-incision slings were developed to overcome the complications related to retropubic and trans-obturator tapes. TVT-Secur was the first of this kind of devices to be marketed and yielded contrasting results. Aim of this non-inferiority study is to report the 5-year follow-up of a randomized, single-blind, controlled trial comparing TVT-O to TVT-Secur. Randomized, single blind, controlled study conducted in two tertiary urogynecological centers. 154 patients were allocated to either TVT-O or TVT-Secur and were contacted 5 years after the procedure to undergo urogynecological examination (POP-Q staging, challenge stress test and post-void residual urine evaluation), to complete I-QOL and PGI-I questionnaires, and to score their satisfaction on a 5-point Likert scale. Patients who were not objectively evaluated were interviewed over the telephone. Primary outcome was subjective success defined as being "very much improved" or "much improved" on the PGI-I. 120 patients were evaluated only subjectively (TVT-O: 62; TVT-Secur: 58) and 84 objectively and subjectively (TVT-O: 46; TVT-Secur: 38). Subjective success (79% vs. 63.8%) and objective cure rates (82.6% vs. 68.4%) 5 years after the procedure were lower for TVT-Secur, but not significantly. Recurrent UTIs were reported by 17.8% of women (TVT-O 9, TVT-Secur 6) and two de novo urgency cases (one per group) were observed. Re-operation rate for stress urinary incontinence (SUI) was 20%. TVT-Secur did not show an inferior subjective success rate in comparison with TVT-O five year after the original procedure, even though displaying a clear trend toward a lower efficacy. Considering that the long-term safety profile is similar between the two procedures, there are no advantages in using TVT-Secur. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
    European journal of obstetrics, gynecology, and reproductive biology. 12/2014; 185C:151-155.
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    ABSTRACT: This is an observational study on 102 women aged 25–45 years to evaluate if the E2V/DNG pill has any impact on quality of life (QoL) and sexual function (FSF). Thirty-nine women were younger than 35 years (group A), and 63 women were 35 years old or older (group B). At baseline and after 6 months, patients received the Italian validated version of the Short Form-36 questionnaire and the Italian validated version of the Female Sexual Function Index questionnaire. Group A showed an overall higher perception in all QoL scores at baseline and after 6-months (p < 0.05). E2V/DNG treatment did not exert any significant effect on QoL perception in group A apart from an increase in the GH domain (general health). In group B we observed a significant improvement both in GH and in VT (vitality) scores. We found a significant reduction in “lubrication” after 6 months both in group A and B (p < 0.01) and a significant improvement in “satisfaction” and “pain” scores in group A and in “desire”, “satisfaction” and “total” score in group B (p < 0.01). The E2V/DNG pill is associated with a significant improvement of GH and VT and with an improvement in FSF with no difference between age groups.
    Gynecological Endocrinology 11/2014; · 1.14 Impact Factor
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    ABSTRACT: lymphoceles are among the most common postoperative complications of pelvic lymphadenectomy , with a reported incidence of 1% to 29% in gynecology oncology. Several studies evaluated the effectiveness of biological glues on reducing lymphoceles,but no data on gynecological patients are available.We evaluated the effectiveness of cyanoacrylic glues (n-butyl cyanoacrylate) ( glubran 2-gem s.r.l, italy) in preventing lymphocele on 30 patients underwent pelvic lymphadenectomy for endometrial or cervical cancer.
    Gynecologic Oncology 06/2014; · 3.69 Impact Factor
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    ABSTRACT: To evaluate the effect of a protocol of local anesthesia and epinephrine associated with sedo-analgesia on post-TVT-O pain in comparison with infiltration of saline and epinephrine. Forty-two patients undergoing TVT-O were randomized into two groups to receive periurethral infiltration with epinephrine only (group A, n = 21) or with epinephrine plus 1 % lidocaine hydrochloride (group B, n = 21). Post-operative pain was assessed using a visual analog scale (VAS) from 0 (absence of pain) to 10 (maximum pain possible), 1, 6, 12 and 24 h after the procedure. The total amount of analgesia was recorded and the proportion of women reporting a pain VAS score ≥4, 1 h after the procedure was calculated. ANOVA for repeated measures and Bonferroni correction, the Student's t test for independent samples, the Mann-Whitney U test, the Fisher exact test, or the χ (2) test for parametric was used. Pain level was significantly lower in group B 1 (p = 0.01) and 6 h (p = 0.05) after surgery, but not 12 and 24 h after the procedure. No significant difference was observed in the proportion of women requesting analgesia and in the total dosage of analgesics between the two groups. A significant higher proportion of women in group A reported a pain VAS score higher than four 1 h after surgery in comparison with patients in group B. This randomized study seems to indicate that systematic infiltration before TVT-O positioning with local anesthetic may reduce immediate post-operative pain.
    Archives of Gynecology 03/2014; · 1.28 Impact Factor
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    ABSTRACT: To compare the efficacy of a personal dietary intervention on gestational weight gain control with a general intervention promoting healthy eating. Prospective, controlled study including 154 low-risk pregnant women randomly allocated to two groups: 77 receiving a personalized diet plan and a close follow-up by a dietician (intervention group), 77 receiving standard dietary care by means of a brochure on healthy eating during pregnancy (control group). Pre-pregnancy weight, gestational age, height, weight and BMI at baseline, weight at term, gestational age at delivery and newborn weight were recorded for all participants. The primary end-point was the difference in body weight between baseline and term. Secondary end-points were the difference in body weight between pre-pregnancy and term and in newborn weights. Maternal weight gain at term was significantly lower both as compared to pre-pregnancy weight (8.2 ± 4.0 vs. 13.4 ± 4.2 kg; p < 0.001) and to weight at baseline (7.7 ± 3.8 vs. 13.7 ± 4.3 kg; p < 0.001) in the intervention group as compared to controls. A positive, significant correlation between the delta weight between baseline and term and newborn weight was observed in both groups, but stronger in patients from the intervention group (intervention group R = 0.76, p < 0.001; control group R = 0.35, p = 0.01). This study suggests that a personalized nutritional intervention, in which the dietician plays an active role within the obstetric team, may represent a successful approach in limiting weight gain in pregnant women.
    Archives of Gynecology 10/2013; · 1.28 Impact Factor
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    ABSTRACT: Abstract The aim of the study was to determine the impact of etonogestrel (ENG)-implant used for contraceptive purpose on Quality of life (QoL) and on sexual function (FSF) of healthy Italian women. The Female Sexual Function Index (FSFI) questionnaire and the Short Form-36 (SF-36) validated questionnaire were administered at baseline, 3 and 6 months after insertion of Nexplanon. The implant seems to have a positive impact on QoL after the first three months of therapy. Users showed an improved general health status and physical role status. The implant did not show negative effects on libido and on sexual function. In the first three months of treatment, users experienced a temporary reduction of vitality, mental health, social functioning and emotional role functioning, which seem to disappear after six months of therapy.
    Gynecological Endocrinology 10/2013; · 1.14 Impact Factor
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    ABSTRACT: Abstract This study shows the effect of a 1 year treatment with an estradiol valerate/dienogest pill in 36 women suffering from polycystic ovaries and mild or moderate acne. At beginning of the study, 24 patients (66.7%) had grade 1-2 (mild) acne and 12 patients (33.3%) had grade 3 (moderate) acne. After 12 cycles of therapy, we found an improvement of acne in 19 (52.8%) patients and a worsening of acne in 3 (8.4%) patients. The percentage of patients recovered was statistically significant (p < 0.01). SHBG levels were significantly higher after 6 and 12 months of therapy (p < 0.001), while total testosterone levels were lower in all patients at 6 and 12 months although this trend did not reach statistical significance. In conclusion, the present study suggests that the E2V/DNG pill could exert a positive influence on acne and hyperandrogenism. Since this is an observational study on a very limited population number, additional randomized controlled studies on larger populations are needed also to determine the effects of this contraceptive over longer periods of use.
    Gynecological Endocrinology 09/2013; · 1.14 Impact Factor
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    ABSTRACT: Objectives To evaluate the effects of a combined oral contraceptive (COC) containing dienogest/oestradiol valerate (DNG/E2V) on bone mineral density (BMD) and on serum and urinary bone turnover markers in young, healthy, fertile women. Methods At baseline and after three and six months of intake of the aforementioned COC, serum and urinary calcium, osteocalcin, urinary pyridinoline (PYD), and deoxypyridinoline (D-PYD) of 30 women aged 21 to 34 years were measured. At baseline and after six months, lumbar bone mineral density was determined by dual-energy X-ray absorptiometry (DEXA). Results Urinary levels of PYD and D-PYD were significantly lower at three and six months in comparison with basal values (p < 0.05). Serum calcium levels showed an increasing trend, which reached statistical significance after six months in comparison with basal values while urinary levels of calcium did not vary significantly. Serum osteocalcin levels were somewhat, but not significantly, lower during pill use in comparison with basal values. After six months, spinal BMD values did not differ significantly from basal values. Conclusions The DNG/E2V COC has no short-term adverse effect on bone turnover markers. No significant change in BMD was observed after six months of use of that pill.
    The European Journal of Contraception and Reproductive Health Care 07/2013; · 1.81 Impact Factor
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    ABSTRACT: OBJECTIVE: To compare the efficacy of the inside-out tension-free vaginal tape-obturator (TVT-O) device versus the single-incision TVT-Secur device 36 months after the procedure. METHODS: A single-blind, randomized, parallel-group study on 154 patients with stress urinary incontinence (77 treated with TVT-O and 77 with the TVT-Secur hammock approach). The primary endpoint was the objective cure rate 36 months after the procedure evaluated with the challenge stress test. Secondary endpoints were subjective cure rate (evaluated with bladder diary, quality-of-life questionnaires, and patient-reported outcome tools) and intraoperative and postoperative complications. The primary endpoint was evaluated with a noninferiority study design. RESULTS: Sixty-six patients in the TVT-O group and 64 in the TVT-Secur group concluded the study. Thirty-six months after the procedure, 57/66 patients (86.4%) in the TVT-O and 50/64 (78.1%) in the TVT-Secur groups were objectively cured (noninferiority unilateral u test: p < .05). No differences were observed in the subjective cure and complication rates. CONCLUSIONS: TVT-Secur seems not to be inferior to TVT-O in the surgical treatment of stress urinary incontinence and causes less postoperative pain. The possibility of severe blood loss cannot be ruled out when TVT-Secur is used.
    Journal of Minimally Invasive Gynecology 01/2013; · 1.58 Impact Factor
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    ABSTRACT: OBJECTIVE: To evaluate the impact of a more limited paraurethral dissection, avoidance of perforating the obturator membrane with scissors or guide, and a more medial trajectory of the trocar in positioning the TVT-O device on stress urinary incontinence cure rates. STUDY DESIGN: One hundred and ten patients were recruited for this randomized, single blind, multicenter, non-inferiority study, with a 1:1 ratio to undergo the traditional (n=55) or the modified (n=55) technique. Preoperatively, patients underwent POP-Q staging, Q-tip test, challenge stress test and urodynamics, and completed the I-QoL, PISQ-12, and PGI-S questionnaires. During the post-operative period, patients attributed a pain VAS score 1, 3, 6, 12 and 24h after the procedure and were followed up at 12 months, undergoing the same baseline evaluations. The primary outcome was the cure rate (absence of urine leaks at the challenge stress test or urodynamic testing) one year after the procedure. The primary outcome was evaluated using a non-inferiority test. RESULTS: No differences were observed in cure rates (traditional technique 92.3% vs. modified technique 88.8% and non-inferiority P<0.05) and in questionnaire scores between the two groups. Post-operative pain was significantly lower in the modified technique group at each time point assessed, with the exception of 12h post-operatively. No differences between the two groups were observed in the number of analgesic vials administered. CONCLUSIONS: The modified technique does not seem to reduce the efficacy of TVT-O, but induces a reduction of post-operative pain.
    European journal of obstetrics, gynecology, and reproductive biology 12/2012; · 1.97 Impact Factor
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    ABSTRACT: In recent years, surgical treatment of stress urinary incontinence has become minimally invasive owing to the introduction of the transobturator route first and then single incision devices for positioning of mid-urethral slings. Although a number of case reports in the literature describe pregnancies successfully terminated both by vaginal delivery and cesarean section following mid-urethral sling positioning, there is still no definitive consensus on which is the preferred mode of delivery in these patients. We report a case of spontaneous vaginal delivery at term in a 41-year-old multiparous woman two years after the positioning of a single incision sling (TVT-Secur). The patient remained continent throughout the gestation and in the following 24 months. This case seems to further support the concept that sling procedures for stress urinary incontinence do not represent an absolute contraindication to spontaneous vaginal delivery, although the preferred mode of delivery must be assessed on an individual basis.
    Journal of Obstetrics and Gynaecology Research 08/2012; · 0.84 Impact Factor
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    ABSTRACT: BACKGROUND: Although a large amount of studies in the literature evaluated the effects of hormonal contraception on bone, many questions remained still unclear, such as the effect of these therapies on fracture risk. STUDY DESIGN: We performed a systematic search of the published studies from January 1975 through January 2012 on the effects of hormonal contraceptives on bone metabolism. We analyzed the overall effect on bone mineral density (BMD) and on fracture risk of combined oral contraceptives (COCs), progestogen-only contraceptives, transdermal contraceptives and vaginal ring. RESULTS: COC therapy does not seem to exert any significant effect on BMD in the general population. In adolescents, the effects of COCs on BMD seem to be mainly determined by estrogen dose. The use of COCs in perimenopausal women seems to reduce bone demineralization and may significantly increase BMD even at a 20-mcg dose. Use of depot medroxyprogesterone acetate is associated with a decrease in BMD, although this decrease seems to be partially reversible after discontinuation. Data on other progestogen-only contraceptives, transdermal patch and vaginal ring are still limited, although it seems that these contraceptive methods do not exert any influence on BMD. CONCLUSIONS: Hormonal contraceptives do not seem to exert any significant effect on bone in the general population. However, other randomized controlled trials are needed to evaluate the effects on fracture risk since the data available are derived from studies having the effects on BMD as the primary end point, and BMD may not accurately reflect the real fracture risk.
    Contraception 06/2012; · 3.09 Impact Factor
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    ABSTRACT: To investigate the impact of a 3 months preoperative administration of an oral contraceptive, containing dienogest (DNG) and estradiol valerate (E(2)V) on the outcome of office operative hysteroscopy (OOH). One-hundred and forty-two patients diagnosed at office hysteroscopy as having an asynchronous endometrium associated with either a broad-base sessile endometrial polyp (>1.5, <2.5 cm) or a uterine septum (>1/3 uterine cavity) or scheduled for tubal sterilization were enrolled into a prospective case-control study at University "Federico II" of Naples. 86/142 patients accepted the preoperative hormonal treatment (Group A), while 56/142 refused, thus becoming controls (Group B). Group A underwent OOH during the 10th-20th days of the third cycle of treatment. In Group B OOH was performed at enrolment, together with the diagnostic procedure. The study outcomes were: endometrial pattern, success rate, operating time, degree of surgical difficulty and pain score. An overall improvement of the endometrium was reported in 100% of cases in Group A. A statistically significant difference in success rate could not be demonstrated between two groups. Operative procedures were performed significantly quicker and easier in Group A than Group B (p < 0.001 and p < 0.05, respectively). The mean Visual Analog Scale (VAS) score was significantly lower in Group A (p < 0.001). A short pretreatment with combined oral contraceptive (COC) containing E(2)V/DNG seems to have a favorable impact on endometrium which in turn may result in an improvement of the overall outcomes of OOH.
    Gynecological Endocrinology 05/2012; · 1.14 Impact Factor
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    ABSTRACT: One of the most frequent and distressing complications of the tension-free vaginal tape obturator (TVT-O) procedure for stress urinary incontinence (SUI) is groin pain, which may be related to the surgical technique or to the tape. The aim of this study was to evaluate the impact of a more limited dissection and a more medial trocar trajectory in TVT-O positioning on postoperative pain. Seventy-two SUI patients were randomized to undergo TVT-O either with the traditional technique (group A) or a modified procedure (reduced paraurethral dissection and a more medial trocar trajectory) (group B). Visual analog scale pain scores 12 h, 24 h, and 1 month after the procedure, number of analgesic vials, objective cure rate, and patient functional and quality of life scores 6 months after the procedure were evaluated. Data were analyzed by the Student's t test for parametric variables, the Mann-Whitney U and Wilcoxon tests for nonparametric variables, and Fisher's exact test for categorical variables. Pain scores were significantly lower in group B compared with group A 24 h after surgery (P = 0.01). Pain scores significantly decreased from 12-24 h postoperatively to 1 month follow-up in both groups (P < 0.001). No significant differences were observed in the number of analgesic vials administered, cure rates, and questionnaire scores between the two groups. More limited dissection and a more medial trocar trajectory of TVT-O seem to reduce postoperative groin pain at 24 h after the procedure, but not the analgesic requirement.
    International Urogynecology Journal 04/2012; 23(9):1293-9. · 2.17 Impact Factor
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    ABSTRACT: To evaluate the mid-term efficacy and safety of the TVT-Secur device in the treatment of stress urinary incontinence. Retrospective study evaluating 68 women affected by stress urinary incontinence treated with TVT-Secur procedure with hammock approach who attended the 24-month follow-up visit. Stress test, urodynamics, patient functional and quality of life questionnaires, visual analog scale pain score, and post-operative complications were evaluated. Data distribution was evaluated using the Shapiro-Wilk's test. Data were analyzed by the Student's t test for parametric variables, the Wilcoxon test for non-parametric variables, and the Chi-squared test for categorized variables. Objective cure rate 24 months after surgery was 80.8 %. Incontinence-quality of life and patient global impression of severity scores showed significant improvement. The only intra-operative complications were a vaginal wall tear and a case of severe bleeding, while post-operative complications were de novo urgency in five cases (7.3 %), one acute urinary retention (1.4 %), and one tape exposure (1.4 %). The study is limited by the retrospective design and the heterogeneity of patients. TVT-Secur seems to be an effective and safe procedure for stress urinary incontinence.
    Archives of Gynecology 04/2012; 286(2):415-21. · 1.28 Impact Factor
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    ABSTRACT: Ovarian hyperstimulation syndrome (OHSS) mostly occurs as a complication of induction of ovulation. However, rarely, it may occur spontaneously at the beginning of a natural pregnancy and in the absence of any assisted reproductive treatment. Spontaneous OHSS has been reported in pregnant women affected by hypothyroidism, polycystic ovary syndrome, gonadotropin-producing pituitary adenoma, but also in normal pregnancies. The aetiology of this condition is still unclear. We hereby report on a case of spontaneous, familial, recurrent OHSS in a 26-year-old primipara whose first-degree cousin, paternal grandmother and a number of other members of her father's family had suffered from a similar condition. This case seems to support the concept of a genetic predisposition for spontaneous OHSS thereby suggesting the need for preventive and therapeutic strategies.
    Gynecological Endocrinology 02/2012; 28(8):649-51. · 1.14 Impact Factor
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    ABSTRACT: To evaluate the impact of hormone replacement therapy and oral contraceptives containing different progestogens on adiponectin and leptin serum levels. Prospective, longitudinal, semi-randomized study. General gynecology clinic of a university hospital. Forty-five healthy postmenopausal and 45 healthy premenopausal women. Thirty postmenopausal women were randomized to receive either drospirenone (DRSP) 2 mg + E(2) 1 mg (n = 15) or norethisterone acetate (NETA) 0.5 mg + E(2) 1 mg (n = 15). Thirty premenopausal women were randomized to receive either ethinilestradiol (EE) 0.020 mg + DRSP 3 mg (n = 15) or EE 0.020 mg + desogestrel 0.15 mg (n = 15). Furthermore, 15 postmenopausal and 15 premenopausal untreated women served as controls. Adiponectin and leptin serum levels before and after 6 months of hormonal therapy. No significant differences in leptin levels were detected in any group after 6 months. Adiponectin levels were significantly reduced in the NETA + E(2) group and increased in the EE + DRSP group, while remaining unmodified in all other groups. Hormone replacement therapy with NETA, but not with DRSP, decreases serum adiponectin levels. Oral contraceptives containing DRSP increase serum adiponectin levels.
    Fertility and sterility 06/2011; 96(1):214-9. · 4.30 Impact Factor
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    ABSTRACT: To reduce complications of transobturator tension-free vaginal tape, single-incision devices were introduced in the last years. We here report a comparison between the tension-free vaginal tape-obturator (TVT-O) and the TVT-Secur techniques in terms of efficacy and safety. Eighty-four patients with stress urinary incontinence (SUI) were scheduled to undergo TVT-O or TVT-Secur. Duration of the procedure, subjective estimate of blood loss, intraoperative and postoperative complications, postoperative postvoidal residue (PVR), time to first voiding, and pain level were recorded. Urodynamic tests, PVR, Incontinence Questionnaire Short Form (ICIQ-SF), King's Health Questionnaire, and a urinary diary were performed before and 12 months after procedure. No differences in terms of cure rate were observed between the two groups (81.6% vs. 83.8%). Complication rate in the TVT-Secur group was lower (8.1%) than in the TVT-O group (15.8%), but not significant. Both techniques seem to be effective and safe, with a low incidence of complications in both groups.
    International Urogynecology Journal 10/2010; 21(10):1211-7. · 2.17 Impact Factor
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    ABSTRACT: To evaluate the effects on bleeding pattern of two different doses of natural progesterone (NP) administered per os or per vagina in association with transdermal estradiol in a continuous, sequential estrogen-progestin therapy. A prospective, randomized trial was conducted on 100 patients randomized into four groups. Each group received transdermal 17beta-estradiol treatment at the dose of 50 microg/day. Groups A and B received NP per os at the dose of 100 mg/day and 200 mg/day, respectively. Groups C and D received NP per vagina at the dose of 100 mg/day and 200 mg/day, respectively. After 12 cycles of treatment, no significant differences were observed in endometrial thickness between groups, suggesting that all treatments are effective in balancing the effects of estradiol on endometrium. Regarding bleeding control, patients in Groups C and D showed a higher number of episodes of regular bleeding than patients in Groups A and B and fewer episodes of spotting. The better control of bleeding was associated with a higher treatment compliance in patients who received vaginal NP, with a larger percentage of women completing the study. Transdermal estrogen replacement therapy combined with 100 mg of micronized NP administered per vagina from the 14th day to the 25th day of each 28-day cycle leads to good cycle control and provides excellent patient satisfaction without serious side-effects. This therapy could be a treatment of first choice in early postmenopausal patients.
    Climacteric 10/2010; 13(5):442-6. · 2.24 Impact Factor

Publication Stats

817 Citations
157.27 Total Impact Points


  • 1993–2013
    • University of Naples Federico II
      • • Section of Psychology
      • • Department of Molecular Medicine and Medical Biotechnology
      Napoli, Campania, Italy
  • 2002–2004
    • Second University of Naples
      • Dipartimento di Psicologia
      Caserta, Campania, Italy