Stefano Cianci

Preliminary Study on the Effect of Four‐phasic Estradiol Valerate and Dienogest (E2V/DNG) Oral Contraceptive on the Quality of Sexual Life

INTRODUCTION A new oral contraceptive containing the natural estrogen estradiol and a 19-nortestosterone derivate dienogest (DNG) in a four-phasic 28-day regimen may be used by women. AIM To investigate the quality of sexual life of healthy women on estradiol valerate and DNG (E2V/DNG) oral contraceptive. METHODS Fifty-seven women (age range 18-48 years) were enrolled. The Short Form-36 (SF-36) questionnaire to assess quality of life (QoL) was administered at baseline and at the 26th day of both the 3rd and 6th cycles of oral contraceptive (OC) intake. The Short Personal Experience Questionnaire (SPEQ) to measure the change of sexual behavior was used at the 2nd, 7th, 14th, 21st, 26th, and 28th days of the baseline cycle, as well as at the same days of both the 3rd and 6th cycle of contraceptive intake. MAIN OUTCOME MEASURE The SF-36 and the SPEQ questionnaires. RESULTS Women reported QoL improvement at the 3rd (P < 0.05) and at the 6th cycles (P < 0.01). By SPEQ, improvement of sexuality during the 3rd and the 6th cycle with respect to baseline experience was observed (P < 0.05). The frequency of sexual activity remained basically unchanged (P = NS). Enjoyment and desire improved at the 6th cycle with respect to the 3rd cycle (P < 0.05). All women reported decreased dyspareunia at the 3rd and 6th cycles (P < 0.05). Interestingly, desire, arousal, orgasm, enjoyment, and sexual activity improved, reaching a peak around the 14th day of the menstrual cycle (P < 0.05). At the 3rd and 6th cycle, women on OCs were sexually cyclic, but the peak improvement of desire, arousal, orgasm, enjoyment, and sexual activity appeared around the 7th day of OC intake (P < 0.05). CONCLUSION Reduced hormone-free interval is a new concept in low-dose OC regimens. Moreover, the E2V/DNG multiphasic extended regimen has been found to positively modify the sexuality of users.

Do Hormones Influence Women's Sex? Sexual Activity over the Menstrual Cycle

INTRODUCTION In mammals, the effects of ovarian steroids influence sexual behavior. In humans, there are a few studies that take into account if ovulation occurs. AIM The study aims to investigate if a womans sexuality changes during the week and over the menstrual cycle, and if so, in what way. METHODS This is a prospective cohort study; 1,957 heterosexual women were involved over the period January 2004-December 2011. Two subgroups were taken into consideration, women having a partner and singles. MAIN OUTCOME MEASURE Sexual interview and the Female Sexual Function Index and Female Sexual Distress Scale questionnaires were used to exclude women with sexual dysfunction. Women with ovulation confirmed by sonography were enrolled. Women were given diary cards on which to report their daily sexual activity. Serum concentrations of estradiol, progesterone, total testosterone, sex hormone binding globulin, and free androgen index were measured during the follicular, periovular, and luteal phase of the menstrual cycle. RESULTS One thousand one hundred eighty women (age range 18-40 years) were included in the analyses. Of them, 925 had a heterosexual relationship and 255 were single. Women with a partner had more sexual activity during the weekend, while the singles had a constant sexual activity over the week. The sexual activity of singles was higher during the ovulatory phase and lower during menses than that of the women with a partner. A linear correlation between sexual activity and androgenic hormonal profile during the menstrual cycle in women with and without a partner was observed. CONCLUSIONS Ovarian steroids modulate a womans sexual activity. This aspect was more evident in singles than in women having a partner, in which a variety of nonhormonal factors can have a role.

Quality of life and sexual changes after double transobturator tension-free approach to treat severe cystocele

OBJECTIVES To study the quality of life and sexual function changes of women affected by severe cystocele and treated with the double transobturator tension-free approach. STUDY DESIGN 23 women (mean age 60.6) with third and fourth degree cystocele (according to Baden and Walker classification) were monitored by Short Form-36 (SF-36) and Pelvic Organ Prolapse/Urinary Incontinenece Sexual Questionnaire (PISQ-12) before and 12 months after surgical treatment. Each woman also underwent translabial color Doppler ultrasonography to measure the Resistance Index (RI), Pulsatility Index (PI), Peak Systolic Velocity (PSV), and End-Diastolic Velocity (EDV) of the clitoral arteries, before surgery and 12 months postoperatively. RESULTS SF-36 showed a considerable increase in all of the categories (physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning, and mental health) compared to those obtained at baseline (P<0.05). PISQ-12 also showed a considerable increase in the behavioural emotive factor score, in the physical factor score, in the partner-related factor score and, consequently, in the total score compared to that obtained at baseline (P<0.05). Color Doppler measurement showed that the mean Pulsatility Index, Peak Systolic Velocity, Resistance Index and End-Diastolic Velocity were not significantly lower to those obtained at baseline (P=NS). CONCLUSIONS Double transobturator tension-free approach to treat severe cystocele considerably improves quality of life and sexual function, and does not significantly influence clitoral blood flow. Our data could add new information about sexual behaviour after prolapse treatment, particularly about the impact on clitoral blood flow changes.

Quality of life and sexual function of naturally postmenopausal women on an ultralow-concentration estriol vaginal gel

Objective:This study aims to evaluate the sexual function and quality of life (QoL) of naturally postmenopausal women affected by genitourinary syndrome of menopause who were treated with an ultralow-concentration estriol vaginal gel (0.005%). Methods:Postmenopausal women with vulvovaginal atrophy symptoms and sexual disorders were enrolled in a case-control study. Women were treated with vaginal gel (containing 50 &mgr;g of estriol) daily for 3 weeks and then twice weekly up to 12 weeks. Determination of vaginal maturation index, evaluation of vaginal pH, and assessment of vaginal atrophy symptoms were carried out. QoL, sexual function, and distress were investigated using the Short Form 36, Female Sexual Function Index, and Female Sexual Distress Scale questionnaires. Changes between baseline and week 12 were assessed. Results:Sixty-eight women were included in the study group, and 42 women were included in the control group. Women on estriol vaginal gel had a significant increase in vaginal maturation index and improvement of vaginal pH compared with baseline (P < 0.05). Mean total Female Sexual Function Index score improved, and Female Sexual Distress Scale score decreased from baseline to follow-up. Results from the Short Form 36 questionnaire showed a significant improvement in the overall index of somatic aspects (P < 0.05). The control group showed no changes from baseline evaluation (P = NS). Conclusions:Estriol vaginal gel (0.005%) therapy significantly improves the trophism of the vaginal mucosa and the sexual health and QoL of naturally postmenopausal women. These results confirm that low doses of vaginal estrogen must be considered as the first choice for the initial treatment of postmenopausal genitourinary symptoms.

Telelap ALF-X vs Standard Laparoscopy for the Treatment of Early-Stage Endometrial Cancer: A Single-Institution Retrospective Cohort Study

STUDY OBJECTIVE To compare the surgical and clinical outcomes of patients affected by early-stage endometrial cancer treated using the Telelap ALF-X platform versus conventional laparoscopic surgery. DESIGN Single institution retrospective cohort study (Canadian Task Force classification II-2). SETTING Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome, Italy. PATIENTS The study involved 89 patients affected by early-stage endometrial cancer who underwent elective surgical staging between October 2013 and September 2014. Among them, 43 (48.3%) underwent Telelap ALF-X staging (ALF-X group), and 46 (51.7%) underwent conventional laparoscopic staging (laparoscopic group). INTERVENTIONS All selected patients underwent laparoscopic staging with radical hysterectomy (class A sec Querleu-Morrow), bilateral salpingo-oophorectomy, and pelvic lymphadenectomy if required. The 2 surgical groups were further divided into patients who did not require pelvic lymphadenectomy (subgroup 1) and those who underwent pelvic lymphadenectomy (subgroup 2). MEASUREMENTS AND MAIN RESULTS In the ALF-X group, the median operative time was 128 minutes (range, 69-260 minutes) for subgroup 1 and 193 minutes (range, 129-290 minutes) for subgroup 2. In the laparoscopic group, the median operative time was 82 minutes (range, 25-180 minutes) in subgroup 1 and 104 minutes (range, 36-160 minutes) in subgroup 2. The difference in operative time between subgroups was statistically significant in both the ALF-X and laparoscopic groups (p = .000). In subgroup 1 of the ALF-X group, there was 1 conversion to standard laparoscopy (2.3%) and 2 conversions to laparotomy (4.7%) (p = .234). No conversions to laparotomy occurred in the laparoscopic group. Postoperative complications included 1 case of pelvic hematoma (2.3%) in subgroup 1 of the ALF-X group and 1 case of subocclusion and 1 case of pulmonary edema (4.3%) in subgroup 1 of the laparoscopic group. CONCLUSION Based on operative outcomes and complication rates, our results suggest that the Telelap ALF-X approach is feasible and safe for endometrial cancer staging; however, further studies are needed to definitively assess the role of Telelap ALF-X early-stage endometrial cancer staging.

Quality of sexual life of women using the contraceptive vaginal ring in extended cycles: preliminary report.

Abstract Objective To evaluate the quality of the sexual life of healthy women who are using a contraceptive vaginal ring (CVR) in extended cycles. Methods Fifty-two women (18 to 32 years old) seeking hormonal contraception were enrolled in this prospective study. Women were to use a CVR releasing daily 15 μg of ethinylestradiol (EE) and 120 μg of etonogestrel (ENG) for 63 days, followed by a four-day hormone-free interval, for two such extended cycles. At baseline and at the first (day 63–73) and second (day 126–134) follow-ups the Female Sexual Function Index (FSFI) and the Short Form-36 (SF-36) questionnaires were administered to investigate, respectively, sexual behaviour and the quality of life (QoL). The Female Sexual Distress Scale (FSDS) was used to verify whether sexual dysfunction caused significant personal distress to the woman. Results The FSFI and FSDS scores obtained at the first and second follow-up appointments detected an improvement with respect to the baseline score (p < 0.05). QoL measures of body pain, general health and emotional role improved at the first follow-up visit (p < 0.05); at the second one, all variables showed improvement (p < 0.05). Conclusion According to these preliminary data the CVR in extended cycles could improve the sexual function and the QoL of women. Chinese Abstract 摘 要 目的 评估在扩展周期中使用阴道避孕环健康女性的性生活质量。 方法 寻求激素避孕的52名女性（18-32岁）参加了这项前瞻性研究。妇女使用阴道避孕环每天释放15μg炔雌醇和120μg依托孕烯,共63天，随后4天是无激素间歇期，持续2个这样的周期。在基础状态及第一（63-73天）和第二（126-134天）周期，用女性性功能指数（FSFI）和简化SF-36表问卷，分别对性行为和生活质量(QoL)进行调查。使用女性性障碍量表(FSDS)来证明性功能障碍是否已经引起了明显的个人困扰。 结果 与基础评分相比，第一次和第二次随访时FSFI和FSDS评分明显提高（p＜0.05）。QoL评分 的身体疼痛，一般健康和情绪评分在第一次随访时明显提高；第二次随访时各项评分均明显提高。 结论 根据这些初步数据，扩展周期的阴道避孕环可能会改善性功能和提高妇女的生活质量。

Effects of ultralow topical estriol dose on vaginal health and quality of life in postmenopausal women who underwent surgical treatment for pelvic organ prolapse

Objective: To evaluate the efficacy of low concentrations of vaginal estriol gel in postmenopausal women with pelvic static disorders before and after vaginal surgical treatment, assessing vaginal health, sexual function, and quality of life (QoL). Methods: Women affected by genital prolapse were enrolled. Vaginal health, QoL, and sexual function were investigated at baseline (T0), before surgery (T1), and 13 weeks after surgery (T2). At baseline, participants were randomized 1:1. Women in group A (38 women) were treated daily with vaginal gel containing 50 &mgr;g estriol for 12 weeks and women in group B (37 women) did not receive any estrogen treatment. After this period and before surgery, a first examination was carried out (T1). One week after surgical treatment, group A underwent randomization 1:1 to group A1 repeating estriol vaginal gel for 12 weeks, and group A2 discontinuing the estrogen treatment. The second follow-up examination (T2) was performed at the 13th week after surgery. Results: All aspects of vaginal health improved in group A on estriol before surgery with respect to baseline (P < 0.001). After surgery, 17 participants of group A1, 16 of group A2, and 30 of group B completed the study. Group A1 (on estriol plus surgery) further improved with respect to the presurgery estriol treatment (P < 0.01). Moreover, group A2 (T2) experienced a worsening of vaginal health versus intragroup presurgery estriol treatment (P < 0.01), and versus intergroup surgical estriol treatment (P < 0.05). QoL improved in women only after surgery, with (P < 0.01) or without (P < 0.05) estriol treatment. Finally, the sexual function of participants on estriol before surgery did not change. On the contrary, it improved after surgery in both participants on estriol (P < 0.001) and without estriol (P < 0.01). Moreover, surgical estriol participants had a better score than surgical no-estriol participants (P < 0.05). Conclusions: Estriol vaginal gel (0.005%) administration significantly improved the vaginal health of natural postmenopausal women before and after vaginal surgery. Both sexual health and QoL also significantly improved after surgery.

Hyperandrogenic women treated with a continuous-regimen oral contraceptive

OBJECTIVES To investigate the effects of a continuous-regimen combined oral contraceptive (COC) on hyperandrogenic women. STUDY DESIGN This prospective study enrolled 52 women with moderate to severe hirsutism, as well as acne and seborrhea. Women were placed on a 192-day continuous regimen. To assess hirsutism, the modified Ferriman-Gallwey (mF-G) scoring system was used. Acne and seborrhea were defined by the Cremoncini scale. Serum FSH, LH, estradiol, total testosterone, FAI, DHEAS, androstenedione, SHBG and fasting insulin were measured at baseline and at the endpoint. One-way ANOVA was used to compare serum hormone levels and hirsutism scores at baseline with those obtained at the endpoint. RESULTS A reduction of 78.5% in the mF-G scores was observed at the endpoint (p<0.001). Women underwent improvement of acne and seborrhea, -58.7% and -56%, respectively (p<0.001). An evident decrease in both total testosterone and FAI, and an increase in SHBG were shown (p<0.001). CONCLUSIONS A COC continuous-regimen improved the esthetic effect of hyperandrogenism.

Sexual function and quality of life of women adopting the levonorgestrel-releasing intrauterine system (LNG-IUS 13.5 mg) after abortion for unintended pregnancy

Abstract Purpose: The aim of the study was to investigate the impact of the long-acting reversible contraception (LARC) levonorgestrel-releasing intrauterine system (LNG-IUS 13.5 mg) on sexual function and quality of life (QoL) in women after having undergone abortion for unintended pregnancy. Methods: In a prospective controlled study, 128 women aged 16–35 years received counseling to adopt LNG-IUS contraception after termination of pregnancy. The Visual Analog Scale (VAS), the Short Form-36 questionnaire (SF-36), the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS) were used to investigate, respectively, pelvic pain levels, QoL, sexual function and sexual distress of these women at baseline (T0) and at 6 (T1) and 12 (T2) months after LNG-IUS placement. Results: Sixty-six (51.6%) women adopted a SARC method, mainly because of the cost of the LNG-IUS. They constituted the control group. The study group consisted of 62 (48.4%) women. Improvement of QoL was observed at T1 (p < .05) and T2 (p < .01). Moreover, sexual function improved and dyspareunia decreased over the study period compared to baseline (p < .001). Dysmenorrhea measured by VAS improved at T1 and at T2 (p < .001). The women of the control group did not experience statistically significant changes at T1 and T2 compared to T0 (p = NS). Conclusions: Women who underwent termination of pregnancy experienced positive changes in QoL and sexual function during LNG-IUS use. These results have to be confirmed in larger studies. However, not all women could adopt the LNG-IUS because of the cost of the contraceptive.

3 mm Senhance robotic hysterectomy: a step towards future perspectives

In the last two decades, surgical approach for hysterectomy has evolved significantly [1]. On the one hand single-site surgery, minilaparoscopy and the more recent percutaneous approach have led to an increasing search of minimal invasiveness [2]; on the other hand, technology reached the highest expression in robotics [3, 4]. Whereas minimizing laparoscopic access permitted to achieve a further and significant reduction of invasiveness while maintaining surgical adequacy, robotic technology allowed the possibility to overcome common limits of laparoscopic approach extending the advantages of endoscopic surgery to “difficult cases” for whom the only surgical way would have been an extensive laparotomy. Apparently, these two trends deeply diverge from each other. However, technological improvement is constantly redefining the concept of the “minimal” surgical approach. In 2013 the introduction of Telelap ALF-X robotic system (now called SenhanceTM—Transenterix USA) represented a unique innovation in this panorama: robotic technology applied to a pure laparoscopic setting with reusable instruments and 5 mm ancillary trocar [5]. System description Senhance surgical platform is based on three independent robotic arms that are remotely controlled by the Surgeon. From the control unit, named “cockpit”, the surgeon drives the robotic arms by utilizing robotic controls that replicate the laparoscopic manipulators. Immediately below the 3D-HD screen, an infrared sensor, the “eye tracking system”, constantly tracks the surgeon’s eye movement and drives the camera according to the specific point the surgeon is looking at. On each robotic arm, 5 or 3 mm strength and reusable instruments can be hooked and inserted in the peritoneal cavity through standard trocars. A 10-mm balloon trocar is inserted in the umbilicus for the 10-mm 3D-HD camera (Viking System). Once the operative procedure has started, each robotic arm detects the force applied on tissues: these data are processed by the system and translated in “haptic feedback” on the control manipulator. Main characteristics of this innovative technology have been widely investigated in terms of safety and efficacy in gynecological procedures in our Division of Gynecologic Oncology of the Policlinico Agostino Gemelli in Rome [6]. Basing on this premises, looking back to published data in terms of ultra-minimally invasive instrumentation and considering the high versatility of the system, Transenterix recently introduced a totally new CE-marked robotic instrumentation: driven by utilizing surgeons’ requests, a set of 3-mm monopolar reusable robotic instruments was developed to cross the line of both minimally invasive and robotic surgery. Representing an absolute innovation, for the first time in the robotic era, 3 mm instruments are hooked on a robotic platform. From July to September 2017, four patients with indication of hysterectomy with bilateral salpingo-oophorectomy for risk-reducing purpose or premalignant endometrial disease were considered eligible for 3 mm Senhance surgery. IRB approval was obtained and the patients were enrolled after the signing of informed consent. The same surgeon with an experience of more than 100 Senhance procedures performed all surgeries. A standard laparoscopic port placement was adopted for the surgical procedures. * Salvatore Gueli Alletti gueliallettis@gmail.com