Giovanni A Tommaselli

University of Naples Federico II, Napoli, Campania, Italy

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Publications (73)170.48 Total impact

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    ABSTRACT: Transvaginal hydrolaparoscopy (THL) is a mini-invasive technique, which allows exploration of the posterior pelvis. THL can be carried out as an office procedure and may replace hysterosalpingography and laparoscopy for the diagnosis of infertility. The aim of this study was to assess pain level during each step of THL. Forty infertile women underwent office THL with local anesthesia and had to score pain on a Likert scale (0-no pain, 5-maximum pain) during five stages of THL: stage 1, introduction of the intrauterine catheter; stage 2, introduction of the Veress needle in the Douglas pouch; stage 3, introduction of the trocar in the pelvis; stage 4, exploration of pelvic organs; stage 5, chromosalpingoscopy. At the end of the study, patients scored their overall satisfaction on a VAS scale (0-not satisfied at all; 10-completely satisfied). Stage 5 was associated with the highest pain score in comparison with stages 1-4 (p < 0.001), while pain score during stage 4 was significantly higher in comparison with stages 1-3 (p = 0.001). Office THL seems to be well tolerated by patients. Chromosalpingoscopy was the least tolerated stage but it does not adversely impact on the procedure, which can be adequately accomplished by performing proper counseling.
    Archives of Gynecology 05/2015; DOI:10.1007/s00404-015-3750-x · 1.28 Impact Factor
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    ABSTRACT: Questions regarding the long-term efficacy and safety of midurethral slings (MUS) are still unresolved, notwithstanding the widespread use of these procedures. The objective of this review was to evaluate the long-term outcomes of retropubic MUS (RP-MUS) procedures and the medium-term outcomes of transobturator MUS (TO-MUS) procedures. MEDLINE, EMBASE, NLH, ClinicalTrials.gov, and Google Scholar databases were searched up to June 2014 with restriction to English language and using the search terms: "stress urinary incontinence", "midurethral sling", "tension-free tape", "transobturator tape", and "follow-up". Studies with a follow-up of 36 months for TO-MUS and 60 months for RP-MUS were searched. Only studies comparing a RP-MUS or TO-MUS with another synthetic sling were included. Data from 49 studies were included. Data were expressed as odds ratios (OR) with 95 % confidence intervals (CI) and combined using the Mantel-Haenszel fixed effects model. Differences in the proportions were evaluated using the chi-squared test. RP-MUS had similar objective cure rates (OR 1.15, 95 % CI 0.75 - 1.76) but higher subjective cure rates than TO-MUS (OR 1.76, 95 % CI 1.08 - 2.86). No differences were observed between outside-in (TOT) and inside-out (TVT-O) and between TO-MUS and minisling. Bladder injuries were more frequent (OR 7.01, 95 % CI 2.94 - 17.90) and vaginal erosions were less frequent for RP-MUS (OR 0.24, 95 % CI 0.07 - 0.84). Vaginal injuries were more common with TOT than with TVT-O (OR 7.96, 95 % CI 1.15 - 157.9). Pain-related complications were more common with TO-MUS than with minimally invasive tapes (OR 8.75; 95 % CI 9.02 - 57.90). MUS have similar objective cure rates in the long term and medium term. TO-MUS is associated with a lower subjective cure rate than RP-MUS.
    International Urogynecology Journal 05/2015; DOI:10.1007/s00192-015-2645-5 · 2.16 Impact Factor
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    ABSTRACT: A relationship between urinary incontinence and hypermobility of the urethrovesical junction (UVJ) during pregnancy has been described. The aim of the study was to compare the effects of vaginal delivery (VD) and caesarean section (CS) on UVJ mobility. The retrovesical angle (RVA) and the anterior angle between the UVJ and the pubic bone, the pubovesical angle (PVA), were evaluated ultrasonographically in controls and pregnant women during their first pregnancy between 38 and 40 weeks, and then re-evaluated 6 weeks and 6 months after delivery. All patients completed a validated questionnaire (ICIQ-SF). Differences between and within groups were assessed with Student's t test, the chi-squared test for trend, and one-way two-tailed analysis of variance with Scheffé's post-hoc test. The correlation between PVA and RVA was evaluated using the Spearman R correlation. The positive predictive value, negative predictive value, sensitivity and specificity for the prediction of stress urinary incontinence (SUI) symptoms were also determined. Included in the study were 42 controls and 217 pregnant women. PVA at rest, during cough and Valsalva manoeuvre was significantly higher in pregnant women than in controls and in women 6 weeks after VD in comparison with women who had undergone CS. Patients affected by SUI showed a significantly higher PVA. RVA did not differ between subjects affected or not by SUI symptoms. PVA and RVA were not correlated with each other. PVA and RVA are increased in pregnant women in comparison with controls. In patients undergoing VD, PVA is restored significantly later than in those undergoing CS. The change in RVA after pregnancy and delivery seems to persist longer than the change in PVA.
    International Urogynecology Journal 05/2015; DOI:10.1007/s00192-015-2736-3 · 2.16 Impact Factor
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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. DOI:10.1016/j.ejogrb.2014.12.012 · 1.63 Impact Factor
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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; DOI:10.3109/09513590.2014.975688 · 1.14 Impact Factor
  • Gynecological Surgery 11/2014; 11(4):261-266. DOI:10.1007/s10397-014-0854-4
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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; 134(3). DOI:10.1016/j.ygyno.2014.06.015 · 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; DOI:10.1007/s00404-014-3186-8 · 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; 289(4). DOI:10.1007/s00404-013-3054-y · 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; DOI:10.3109/09513590.2013.848851 · 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; DOI:10.3109/09513590.2013.831834 · 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; DOI:10.3109/13625187.2013.811483 · 1.84 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; DOI:10.1016/j.jmig.2012.11.008 · 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; 167(2). DOI:10.1016/j.ejogrb.2012.11.014 · 1.63 Impact Factor
  • International Journal of Gynecology & Obstetrics 10/2012; 119:S504. DOI:10.1016/S0020-7292(12)61122-9 · 1.56 Impact Factor
  • International Journal of Gynecology & Obstetrics 10/2012; 119:S316. DOI:10.1016/S0020-7292(12)60587-6 · 1.56 Impact Factor
  • International Journal of Gynecology & Obstetrics 10/2012; 119:S580. DOI:10.1016/S0020-7292(12)61342-3 · 1.56 Impact Factor
  • International Journal of Gynecology & Obstetrics 10/2012; 119:S315-S316. DOI:10.1016/S0020-7292(12)60586-4 · 1.56 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; 39(2). DOI:10.1111/j.1447-0756.2012.01991.x · 0.93 Impact Factor