Laparoscopic sacrocolpopexy versus pelvic organ prolapse suspension for surgical management of pelvic organ prolapse: a retrospective study.

This retrospective surgical clinical study compares clinical and functional effects of laparoscopic sacrocolpopexy (LSC) and laparoscopic pelvic organ prolapse suspension (L-POPS) for anterior and central prolapse correction. Thirty patients enrolled were affected by a symptomatic vaginal central compartment stage 2-3 prolapse and vaginal anterior compartment stage 1-3 prolapse without vaginal posterior compartment prolapse. A successful correction of anterior and central compartments prolapse without relapses were observed in both groups (LSC group versus L-POPS group). In patients who underwent L-POPS, a de novo posterior compartment prolapse was recorded. In this group, 7/15 patients complained more bowel symptoms and underwent vaginal colpoperineoplasty. In 20% (group LSC) and in 13.3% (group L-POPS) of cases, a condition of de novo urinary stress incontinence was described. LSC seems to remain the gold standard for pelvic organ prolapse correction, while further preventive strategies should be carried out in L-POPS to avoid a de novo posterior compartment prolapse.Impact StatementWhat is already known on this subject? Laparoscopic sacrocolpopexy is the gold standard technique for the correction of pelvic organ prolapse; however, laparoscopic pelvic organ prolapse suspension, based on the surgical technique of lateral suspension, is an innovative surgical method for the treatment of POP.What do the results of this study add? L-POPS could be considered a valid alternative to LSC for women with multiple comorbidities because of less operative time and reduced surgical risks. However, in the long follow-up period, some patients underwent L-POPS complained rectal discomfort and dysfunction on quality of life questionnaire and on clinical evaluation from six to twelve months after surgery probably due to the post-operative appearance of posterior compartment prolapse.What are the implications of these findings for clinical practice and/or further research? Considering the retrospective design and the small sample size the major limits of this study, larger, prospective, randomized studies could be encouraged to better compare a modified technique of L-POPS with posterior mesh apposition (preventing the post-operative appearance of posterior compartment prolapse) with the gold standard LSC for the correction of multi-compartment POP.

Comparison of absorbable and permanent sutures for laparoscopic sacrocervicopexy: A randomized controlled trial.

INTRODUCTION: Pelvic organ prolapse is a common cause of morbidity and decreased quality of life among women and is treatable by laparoscopic sacrocolpopexy. Recent data suggest that absorbable sutures are a feasible and appealing option for mesh attachment given a potential decreased risk of complications related to mesh erosion. The aim of the present study was to demonstrate the non-inferiority of absorbable sutures to permanent sutures for laparoscopic sacrocervicopexy. MATERIAL AND METHODS: We performed a randomized, single-blinded, non-inferiority trial comparing late-absorbable sutures (group A) to non-absorbable sutures (group B) for anterior and posterior vaginal mesh fixation during laparoscopic sacrocervicopexy at a single center in Italy. The primary outcome was prolapse correction at 12 months after surgery, defined as the absence of a pelvic organ prolapse leading edge reaching or extending below the level of the hymen and the absence of bulge symptoms. Secondary outcomes included intraoperative parameters, postoperative characteristics, and long-term morbidity. Statistical analyses were performed using STATA version 16. RESULTS: A total of 150 patients with pelvic organ prolapse were prospectively randomized 1:1 into two groups (A or B). Baseline characteristics and intraoperative parameters including blood loss, operation time, and intraoperative complications were comparable between groups. The success rate was 100% in both groups and no differences in prolapse correction were observed. The rates of de novo urinary incontinence and persistent urinary incontinence were also similar between groups. The rate of mesh erosion at 12 months was 0% in group A and 4% in group B (P = .24). CONCLUSIONS: Late absorbable sutures are non-inferior to non-absorbable sutures for laparoscopic sacrocervicopexy in terms of procedural success. Moreover we did not see any differences in terms of operative parameters, or intraoperative and postoperative characteristics, although the study was not powered to these outcomes.

Local ultra-low-dose estriol gel treatment of vulvo-vaginal atrophy: efficacy and safety of long-term treatment.

Vulvo-vaginal atrophy (VVA) is a chronic condition affecting many postmenopausal women. Local estrogen treatment is recommended. Evaluating efficacy and safety of long-term VVA treatment with ultra-low-dose estriol gel, 120 postmenopausal VVA women were enrolled in a prospective study. They received the first cycle of 1 g/day vaginal gel containing 50 µg estriol for 3 weeks and then twice a week for 12 weeks. Moderate or severe VVA women received a second treatment cycle reaching treatment of 30 weeks. Vaginal pH measurement, subjective symptoms, and objective signs assessment of VVA, endometrial thickness and adverse events (AE) were recorded. Of the 99 women, completing the first phase, 43% experienced a complete VVA symptom relief, and 65% presented a milder VVA degree. After 30 weeks, VVA signs significantly improved (p<.01) compared with baseline and first phase results; total objective symptom evaluation including Schiller's test, flattening of folds and vaginal pH significantly improved (p<.01). At study endpoint, none of the patients had severe VVA, 93% had a positive response, 75% had a complete symptom, and sign resolution. No treatment-related endometrial AE were observed. Postmenopausal VVA long term-treatment with ultra-low-dose estriol vaginal gel is safe and effective.

Carbon dioxide in office diagnostic hysteroscopy: An open question. A multicenter randomized trial on 1982 procedures.

OBJECTIVE: to compare carbon dioxide and saline solution distension in diagnostic hysteroscopies with regards to patient discomfort and procedural time and in accordance with the instrument diameter (5 mm vs 3.5 mm). The secondary outcome was to evaluate the role of the patient age and the obstetrical history on perception of pain and procedural time. STUDY DESIGN: This is a prospective multicenter randomized study including 1982 patients that underwent office diagnostic hysteroscopy in: Policlinico Abano Terme, Università Cattolica del Sacro Cuore in Rome and Ente Ecclesiastico Ospedale Generale Regionale "F. Miulli" in Acquaviva delle Fonti. They were firstly randomized according to distension medium and secondly according to instrument diameter. Pain perception after the procedure was assessed by VAS (Visual Analogue Scale) score and procedural time was registered. Mann-Whitney U test was used to compare data. RESULTS: Lower pain score and procedural time were recorded with the employment of Carbon Dioxide (p < 001). Patient discomfort and procedural time were significantly influenced by the instrument diameter independent of the distension medium used, though in the subgroup where gas was employed VAS score after 1 min (VAS1) resulted lower compared to saline solution in both the traditional and mini-hysteroscopy procedures (p < 001). CONCLUSION: Carbon dioxide and saline solution are both suitable distension media for outpatient diagnostic hysteroscopy; nonetheless, carbon dioxide confers advantages in terms of pain perception and procedural time.

Melatonin Treatment May Be Able to Restore Menstrual Cyclicity in Women With PCOS: A Pilot Study.

The objective of the study was to investigate the effects of 6 months of melatonin administration on clinical, endocrine, and metabolic features of women affected by polycystic ovary syndrome (PCOS). This is a prospective cohort study including 40 normal-weight women with PCOS between January and September 2016, enrolled in an academic research environment. Ultrasonographic pelvic examinations, hirsutism score evaluation, hormonal profile assays, oral glucose tolerance test, and lipid profile at baseline and after 6 months of melatonin administration were performed. Melatonin treatment significantly decreased androgens levels (free androgen index: P < .05; testosterone: P < .01; 17 hydroxyprogesterone: P < .01). Follicle-stimulating hormone levels significantly raised ( P < .01), and anti-Mullerian hormone serum levels significantly dropped after 6 months of melatonin treatment ( P < .01). No significant changes occurred in glucoinsulinemic and lipid parameters after treatment except a significant decrease of low-density lipoprotein cholesterol. Almost 95% of participants experienced an amelioration of menstrual cycles. Until now, only few data have been published about the role of melatonin in women with PCOS. This is the first study focused on the effects of exogenous oral melatonin administration on the clinical, endocrine, and metabolic characteristics of patients with PCOS. After 6 months of treatment, melatonin seems to improve menstrual irregularities and biochemical hyperandrogenism in women with PCOS through a direct, insulin-independent effect on the ovary. Based on our results, melatonin could be considered a potential future therapeutic agent for women affected by PCOS.

Neuroendocrine Regulation of Food Intake in Polycystic Ovary Syndrome.

Several peripheral and central signals are involved in the sophisticated regulation of food intake. Women with polycystic ovary syndrome (PCOS) are prone to consume a diet higher in saturated fat and foods with high glycemic index and show impaired appetite regulation and measures of satiety. As a consequence, obesity, mostly of the central type, is prevalent in the syndrome and worsens the endocrine and metabolic profile of the affected patients. This review article briefly analyzes the current knowledge about the neuroendocrine mechanisms underlying the interplay between feeding behavior, obesity, and reproductive abnormalities in PCOS.

Myoinositol combined with alpha-lipoic acid may improve the clinical and endocrine features of polycystic ovary syndrome through an insulin-independent action.

The aim of our study was to investigate the effects of a combined treatment with alpha-lipoic acid (ALA) and myoinositol (MYO) on clinical, endocrine and metabolic features of women affected by polycystic ovary syndrome (PCOS). In this pilot cohort study, forty women with PCOS were enrolled and clinical, hormonal and metabolic parameters were evaluated before and after a six-months combined treatment with ALA and MYO daily. Studied patients experienced a significant increase in the number of cycles in six months (p < 0.01). The free androgen index (FAI), the mean androstenedione and DHEAS levels significantly decreased after treatment (p < 0.05). Mean SHBG levels significantly raised (p < 0.01). A significant improvement in mean Ferriman-Gallwey (F-G) score (p < 0.01) and a significant reduction of BMI (p < 0.01) were also observed. A significant reduction of AMH levels, ovarian volume and total antral follicular count were observed in our studied women (p< 0.05). No significant changes occurred in gluco-insulinaemic and lipid parameters after treatment. The combined treatment of ALA and MYO is able to restore the menstrual pattern and to improve the hormonal milieu of PCOS women, even in the absence of apparent changes in insulin metabolism.

Metformin vs myoinositol: which is better in obese polycystic ovary syndrome patients? A randomized controlled crossover study.

CONTEXT: Due to the central role of metabolic abnormalities in the pathophysiology of polycystic ovary syndrome (PCOS), insulin sensitizing agents have been proposed as a feasible treatment option. OBJECTIVE: To investigate which is the more effective between metformin and myoinositol (MYO) on hormonal, clinical and metabolic parameters in obese patients with PCOS. STUDY DESIGN: Crossover randomized controlled study. PATIENTS: Thirty-four PCOS obese women (age: 25·62 ± 4·7 years; BMI: 32·55 ± 5·67 kg/m2 ) were randomized to receive metformin (850 mg twice a day) or MYO (1000 mg twice a day) for 6 months. After a 3 month washout, the same subjects received the other compound for the following 6 months. MEASUREMENTS: Ultrasonographic pelvic examinations, hirsutism score, anthropometric and menstrual pattern evaluation, hormonal profile assays, oral glucose tolerance test (OGTT) and lipid profile at baseline and after 6 months of treatment were performed. RESULTS: Both metformin and MYO significantly reduced the insulin response to OGTT and improved insulin sensitivity. Metformin significantly decreased body weight and improved menstrual pattern and Ferriman-Gallwey score. Metformin treatment was also associated with a significant decrease in LH and oestradiol levels, androgens and anti-müllerian hormone levels. None of these clinical and hormonal changes were observed during MYO administration. CONCLUSIONS: Both treatments improved the glyco-insulinaemic features of obese PCOS patients, but only metformin seems to exert a beneficial effect on the endocrine and clinical features of the syndrome.

Expectant management may reduce overtreatment in women affected by unexplained infertility confirmed by diagnostic laparoscopy.

PURPOSE: To determine whether the mini-invasive surgery still play a role in the diagnostic workup and in the management of the couples affected by unexplained infertility. METHODS: 170 infertile women (age range 25-38 years) with documented normal ovarian, tubal and uterine function underwent combined hysteroscopic and laparoscopic surgery; 100 women refused surgery or ART treatment (control group) choosing expectant management. A retrospective assessment questionnaire was proposed to enrolled women to collect the rate of spontaneous or ART-induced pregnancies. RESULTS: The combined surgery revealed pelvic pathologies in 49.4% of patients, confirming the diagnosis of unexplained infertility only in 86 of studied patients. In this group of 86 selected women, 28 of them achieved a spontaneous pregnancy and 23 women obtained pregnancy after ART. The Chi-square analysis shows that the pregnancy rate was not influenced by the employment of ART. In the group of 100 control women, only 14 (14%) achieved a spontaneous pregnancy after 18 months of expectant management. CONCLUSIONS: Combined laparoscopy and hysteroscopy in women with unexplained infertility may reveal previously undiagnosed pathologies that could require ART, and in those without abnormal surgical finding, ART does not improve pregnancy rate.

The link between metabolic features and TSH levels in polycystic ovary syndrome is modulated by the body weight: an euglycaemic-hyperinsulinaemic clamp study.

OBJECTIVE: To evaluate the link among thyroid function, glucose/insulin metabolism and steroid hormones in women with polycystic ovary syndrome (PCOS), and to verify if the body mass index (BMI) might influence the interplay between PCOS features and subclinical hypothyroidism (SCH). STUDY DESIGN: Case-control study conducted from January to December 2014. METHODS: One-hundred fifty-four young women with PCOS, according to Rotterdam criteria, and 88 controls were enrolled in an academic research environment. Anthropometric evaluation, hormonal and lipid assays, oral glucose tolerance test (OGTT) and euglycaemic-hyperinsulinaemic clamp were performed. Hirsutism was assessed with the Ferriman-Gallwey (FG) score. MAIN RESULTS: SCH was found in 14% of PCOS subjects and in 1% of controls (P < 0.01). In PCOS women, TSH levels were directly correlated with fasting glycaemia, but not with other hormonal and metabolic parameters. When PCOS patients were classified on the basis of BMI, TSH levels significantly correlated with insulin secretion, insulin resistance, DHEAS and cortisol levels in obese PCOS women. Inverse correlations were found between TSH and both oestradiol and SHBG in the same group. In nonobese PCOS patients, only waist-to-hip ratio values were correlated with TSH. The prevalence of SCH was not different between nonobese and obese PCOS groups (14 and 15% respectively). However, SCH was associated with higher levels of insulin, DHEAS, cortisol and FG score only in the obese subgroup. CONCLUSIONS: Our data confirm that the prevalence of SCH is increased in PCOS women. The presence of SCH is associated with endocrine and metabolic imbalances of PCOS, and the excessive body weight seems to promote this interplay.

Using a 16-French resectoscope as an alternative device in the treatment of uterine lesions: a randomized controlled trial.

OBJECTIVE: To compare a 16-French resectoscope with a 22-French resectoscope and a 15-French hysteroscope for the treatment of uterine cavity lesions. METHODS: This was a prospective, randomized study of women with endometrial polyps or submucous myomas treated with a 16-French resectoscope, a traditional 22-French resectoscope, or a 15-French hysteroscope. The operating time, volume of distension medium delivered, discharge time, and patient discomfort by visual analog scale were recorded. Data were compared by one-way and two-way analysis of variance as appropriate. RESULTS: Four hundred one women were included in the analysis. All four parameters showed lower values in the 16-French resectoscope group (142 women) compared with the 15-French hysteroscope group (132 women; P<.01). The mean operating time was 10.87±2.87 minutes in the 22-French group (127 women), 8.33±2.94 minutes in the 16-French group, and 17.11±6.86 minutes in the 15-French group. The mean volume of distension medium delivered was 1,043±230 mL in the 22-French group, 991±442 mL in the 16-French group, and 1,489±566 mL in the 15-French group. The mean discharge time was 1.99±0.72 hours in the 22-French group, 1.08±0.18 hours in the 16-French group, and 1.89±0.68 hours in the 15-French group. Finally, the mean visual analog scale scores were 2.10±0.97 in the 22-French group, 1.93±1.03 in the 16-French group, and 4.00±1.61 in the 15-French group. An analysis of patients subdivided according to the lesion size (less than 1.5 cm and more than 1.5 cm in diameter) showed similar results. CONCLUSION: The new 16-French resectoscope is effective for the "see and treat" approach for both small (less than 1.5 cm diameter) and large (more than 1.5 cm diameter) uterine lesions.

Follicular loss in endoscopic surgery for ovarian endometriosis: quantitative and qualitative observations.

OBJECTIVE: To identify a possible marker of follicular depletion in relation to some histologic parameters of endometriotic cysts. DESIGN: Prospective study. SETTING: Università Cattolica del Sacro Cuore, Operative Division of Endocrinological Gynecology. PATIENT(S): Seventy-seven patients (aged 20-40 years) with endometrioma. INTERVENTION(S): Patients underwent laparoscopic surgery for ovarian endometriosis. MAIN OUTCOME MEASURE(S): After excision of the cyst wall, involuntarily removed follicles were correlated with age at surgery and with intrinsic histologic parameters of the specimen (thickness and composition of capsule; size of cyst). RESULT(S): There was a statistically significant relationship between patient age and number of follicles in the histologic section, a statistically significant inverse relationship between size of cyst and number of follicles, and no significant correlation between thickness of the capsule and number of follicles. Fibroblastic-type capsule, most frequently found in younger patients, was associated with removal of a significantly higher number of follicles. CONCLUSION(S): Our study suggests that patient age and cyst dimension are related to the histologic composition of the capsule, which is a marker of the aggressiveness of the cyst itself.

Low-dose estrogen and drospirenone combination: effects on glycoinsulinemic metabolism and other cardiovascular risk factors in healthy postmenopausal women.

OBJECTIVE: To evaluate the effects of a daily E2 (1 mg) plus drospirenone oral formulation (2 mg) on glycoinsulinemic metabolism, lipid profile, and endothelial function in symptomatic healthy menopausal women. DESIGN: Randomized, double-blind study. SETTING: Operative Division of Endocrinological Gynecology, Catholic University of the Sacred Heart, Rome, Italy. PATIENT(S): Forty postmenopausal women. INTERVENTION(S): Patients were randomly submitted to receive treatment with an oral dose of E2 (1 mg) plus drospirenone (2 mg) (group A) or placebo (group B). MAIN OUTCOME MEASURE(S): Hormonal and lipid assessment; evaluation of glucose and insulin metabolism by the clamp test and the oral glucose tolerance test; evaluation of endothelial function by the vascular reactivity test. RESULT(S): Total cholesterol levels, low-density lipoprotein cholesterol levels, and nonesterified fatty acids levels significantly decreased both after 3 and 6 months. No changes in high-density lipoprotein, triglycerides, apolipoprotein A1, apolipoprotein B, and lipoprotein (a) were found. Treatment resulted in few changes in glycoinsulinemic metabolism. We observed a significant reduction of the area under curve of insulin after 6 months of therapy. Endothelial function was significantly influenced by treatment, and an improvement in both flow-mediated dilatation and nitrate-mediated dilatation values after 6 months was observed. CONCLUSION(S): Low-dose E2/drospirenone treatment did not reveal any negative effect on carbohydrate metabolism, acting in a neutral way on insulin sensitivity. The treatment induced favorable changes in lipid profile and showed a significant improvement of vascular reactivity.