Post-operative ovarian adhesion formation after ovarian drilling: a randomized study comparing conventional laparoscopy and transvaginal hydrolaparoscopy.

PURPOSE: To compare conventional laparoscopic ovarian drilling (LOD) with transvaginal hydrolaparoscopy (THL) ovarian drilling in terms of ovarian adhesion formation, evaluated using office THL during follow-up in CC-resistant anovulatory patients affected by PCOS. METHODS: Prospective randomized study on 246 CC-resistant women with PCOS. The patients enrolled were divided into two groups, 123 were scheduled to undergo LOD and 123 to undergo THL ovarian drilling. Six months after the procedure all patients were offered office transvaginal hydrolaparoscopy (THL) follow-up, under local anesthesia to evaluate adhesion formation. RESULTS: Duration of the procedure was significantly shorter in the THL group in comparison with LOD group (p < 0.0001). No intra- or post-operative complication was observed in any of the patients in both groups. Post-operative THL follow-up after 6 months showed that 15 (15.5 %) patients in the THL group and 73 (70.2 %) in the LOD group showed the presence of ovarian adhesion. This difference was highly significant with a p value <0.0001 and a relative risk of 0.22 [95 % IC 0.133-0.350]. CONCLUSION: This study seems to indicate that THL ovarian drilling may reduce the risk of ovarian adhesion formation and could be used as a safe and effective option to reduce ovarian adhesion formation in patients undergoing ovarian drilling.

"In patient" medical abortion versus surgical abortion: patient's satisfaction.

OBJECTIVE: To compare patients' satisfaction with medical and surgical abortion, implementing the Italian guidelines on medical abortion entailing an "in patient" procedure. METHODS: A total of 1832 pregnant chose between surgical (vacuum aspiration) or medical abortion (mifepristone p.o. followed after 3 days by sublingual misoprostol) and expressed their expected satisfaction on a visual analog scale (VAS). A total of 885 women chose surgical and 947 medical abortion. The primary end-point was satisfaction VAS score 20 days after the procedure. Secondary end-points were: difference between pre- and post-abortion VAS score; difference in satisfaction VAS scores according to parity and previous abortion; incidence of side effects. RESULTS: VAS score was high in each group but significantly higher for the 1-day surgical than for the 3-day medical abortion procedure (7.9 ± 1.0 versus 7.2 ± 1.2; p < 0.0001). In the surgical group the VAS score increased after the treatment (6.9 ± 1.6 versus 7.9 ± 1.0, p < 0.0001), while it decreased in the medical group (7.5 ± 1.0 versus 7.2 ± 1.2; p < 0.0001). Multiparous women reported higher satisfaction with medical abortion; women with a previous abortion preferred surgical abortion. CONCLUSIONS: Both procedures are considered satisfactory by the patients. Performing medical abortion as a 3-day "in patient" procedure, decreased women's satisfaction scores from their baseline expectations.

Comparison of bidirectional barbed suture Stratafix and conventional suture with intracorporeal knots in laparoscopic myomectomy by office transvaginal hydrolaparoscopic follow-up: a preliminary report.

OBJECTIVES: To compare surgical outcomes of different types of intracorporeal sutures for laparoscopic posterior myomectomy, by a prospective randomized study. STUDY DESIGN: Prospective randomized study on 47 patients with single posterior intramural myoma (4-7cm in diameter) undergoing laparoscopic myomectomy. The patients enrolled were divided into two groups, one operated using conventional suture in double strand, and the other with bidirectional barbed suture Stratafix. The main outcome measures were suturing time, peri-operative variables, and post-operative adhesions in both groups. RESULTS: The mean operative time was shorter with the Stratafix™ than with the conventional suture (66.3±8.2 vs. 73±8min; p=0.005). Suturing time was significantly shorter in the Stratafix™ than in the control group (8.8±2.4 vs. 15.5±2.8min; p=0.001). Intraoperative bleeding was significantly less in the Stratafix group (p=0.0012). Conversely, there was no statistically significant difference for postoperative adhesions between the two groups (26.7% vs. 21.4% p=0.5). CONCLUSIONS: The use of barbed suture may reduce operative time, suturing time, and blood loss. No difference in post operative adhesions was found.

In-office transvaginal hydrolaparoscopy: a step-by-step, intraoperative pain evaluation.

PURPOSE: 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. METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.

Ultrasonographic evaluation of urethrovesical junction mobility: correlation with type of delivery and stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Effects of estradiol valerate and dienogest on quality of life and sexual function according to age.

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.

The role of a personalized dietary intervention in managing gestational weight gain: a prospective, controlled study in a low-risk antenatal population.

PURPOSE: To compare the efficacy of a personal dietary intervention on gestational weight gain control with a general intervention promoting healthy eating. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Impact of an implantable steroid contraceptive (etonogestrel-releasing implant) on quality of life and sexual function: a preliminary study.

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.

Efficacy and tolerability of oral bovine lactoferrin compared to ferrous sulfate in pregnant women with iron deficiency anemia: a prospective controlled randomized study.

OBJECTIVE: To compare the effects of bovine lactoferrin with ferrous sulfate on iron nutritional status and to evaluate their tolerability in 100 pregnant women with iron deficiency anemia. DESIGN: Prospective, randomized, controlled, double blind trial. SETTING: Obstetrics clinic of a University Department of Obstetrics and Gynecology. POPULATION: One-hundred pregnant, healthy women to be treated either with one capsule of 100 mg bovine lactoferrin twice a day (Group A; n=49) and 520 mg ferrous sulfate once a day (Group B; n=48). METHODS: After 30 days, we evaluated hemoglobin (Hb), serum ferritin, serum iron and total iron- binding capacity (TIBC) values. All women were asked to keep a diary of five potential gastrointestinal side effects (abdominal pain, nausea, vomiting, diarrhea and constipation). For each symptom, patients had to rate its severity according to a scale ranging from 0 (absent) to 3 (severe). MAIN OUTCOME MEASURES: Hb level before and after treatment. Secondary outcomes were serum ferritin, serum iron and TIBC levels and the difference in symptom scores between groups. RESULTS: In Groups A and B, Hb, serum ferritin and iron were significantly increased while TIBC was significantly reduced in comparison with basal values. No significant differences were observed between Groups A and B. The median scores of abdominal pain and constipation were significantly higher in patients treated with ferrous sulfate in comparison with those treated with bovine lactoferrin. CONCLUSIONS: The results show that bovine lactoferrin has the same efficacy as ferrous sulfate in restoring iron deposits with significantly fewer gastrointestinal side effects.

Short-term effects of a combination of isoflavones, lignans and Cimicifuga racemosa on climacteric-related symptoms in postmenopausal women: a double-blind, randomized, placebo-controlled trial.

The present study aimed to evaluate the short-term effects of a combination of isoflavones, lignans and Cimicifuga racemosa on acute climacteric-related symptoms in postmenopausal women in a double-blind, randomized, placebo-controlled trial performed at the menopause clinic of our department. Eighty healthy postmenopausal women were randomly assigned to two treatment groups - one receiving the combination (group A, n = 40), the other receiving calcium supplements (group B, n = 40) - for three cycles of 28 days. Climacteric-related symptoms were evaluated by the Kupperman index (KI) at baseline and after the three cycles of treatment. At baseline no significant difference was detected in KI between groups A and B; however, after three cycles of treatment, KI was significantly (p < 0.05) lower in group A compared with baseline and with group B. We conclude that the administration of a combination of isoflavones, lignans and C. racemosa already reduces acute climacteric symptoms in postmenopausal women after 3 months of treatment. This prompt effect is probably due to the different pharmacokinetic properties of isoflavones and lignans; isoflavones are absorbed faster than lignans, while lignans are removed later. The combination of these molecules can guarantee a better reduction of postmenopausal symptoms over a 24-h period.

Effects of two types of hormonal contraception--oral versus intravaginal--on the sexual life of women and their partners.

BACKGROUND: Data relating to the influence of hormonal contraception on sexual life are conflicting and mostly they refer to oral contraceptives. In this randomized, controlled, prospective study we compared the effect of an intravaginal hormonal contraceptive with the effect of a combined oral contraceptive on sexual function. METHODS: Fifty-one healthy women with a permanent partner and an active sexual life were randomly divided in two groups according to a computer-generated randomization list: 26 women (group A) used an intravaginal contraceptive releasing 120 microg/day of etonogestrel and 15 microg/day of ethinylestradiol (EE) and 25 women (group B) used an oral contraceptive containing 20 microg di EE and 150 microg of desogestrel. Twenty-five women participated in the study as control group (group C). A specific questionnaire was completed by the patients and their partners at the start of the study and after cycles 3 and 6 of contraceptive use. RESULTS: Within 3 months of contraceptive use, women from both groups A and B reported a global improvement in sexual function. A statistically significant increase in sexual fantasy was reported only by patients of group A. Whereas partners of the women in both groups A and B reported an improvement in sexual function after 3 months of contraceptive intake, only patients' partners of group A reported a significant increase in sexual interest, complicity and sexual fantasy. CONCLUSIONS: Both hormonal contraceptives tested were seen to have a positive effect on some aspects of sexual function. The intravaginal contraceptive ring seems to exert a further positive effect on the psychological aspect of both women and their partners, which is evident from an improved complicity and sexual satisfaction.

Effectiveness of auto-cross-linked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic adhesiolysis: a prospective, randomized, controlled study.

BACKGROUND: A prospective, randomized, controlled study was performed to assess the efficacy of auto-cross-linked hyaluronic acid (ACP) gel in preventing the development of intrauterine adhesions following hysteroscopic adhesiolysis. METHODS: Ninety-two patients with irregular menses and intrauterine adhesions referred to the Hysteroscopic Unit of the University of Naples "Federico II". Patients were randomized to two different groups. Group A were randomized to hysteroscopic adhesiolysis plus intrauterine application of ACP gel (10 ml) and group B were randomized to operative hysteroscopy alone (control group). Baseline adhesion scores were calculated for each patient and at 3 months after surgery. RESULTS: Group A showed a significant decrease in intrauterine adhesions at 3 months follow-up in comparison with the control group. Staging of adhesions showed a significant decrease in adhesion severity in patients treated with ACP gel. CONCLUSIONS: ACP gel significantly reduces the development of intrauterine adhesions postoperatively and its use is likely to be associated with a reduction of severe adhesions.