Sexual function after vaginal erbium laser: the results of a large, multicentric, prospective study.

The aim of this multicentric, prospective study was to evaluate the effects of vaginal erbium laser (VEL-SMOOTH®) on sexual function in postmenopausal women suffering from the genitourinary syndrome of menopause (GSM). This study was performed on an outpatient basis without anesthesia or drug use before or after the intervention, using an erbium laser (XS Fotona Smooth®, Fotona, Ljubljana, Slovenia) in 1081 postmenopausal women (age 54.3 ± 3.9 years) treated with up to three laser applications every 30 days. Patients were assessed using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R). No adverse events were recorded during the study. The FSDS-R scores (n = 554), from basal values of 25.5 ± 3.5, were 11.5 ± 3.0, 10.5 ± 3.5 and 11.5 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively (p < 0.01 vs. corresponding basal values). Individual FSFI domain scores (n = 569) significantly (p < 0.001) increased after VEL-SMOOTH® treatment and remained significantly higher up to the 24th week after the end of treatment. The total scores, from basal values of 15.5 ± 1.5, were 27.5 ± 2.5, 27.6 ± 2.7and 27.0 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively (p < 0.01 vs. corresponding basal values). Albeit not randomized, this large, prospective study shows that VEL-SMOOTH® treatment may improve sexual function in postmenopausal women suffering from GSM.

Rationale and design for the Vaginal Erbium Laser Academy Study (VELAS): an international multicenter observational study on genitourinary syndrome of menopause and stress urinary incontinence.

The genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI) are common clinical challenges for women's health and quality of life. The laser treatment and particularly the vaginal erbium laser (VEL) may provide a new non-invasive treatment for both GSM and SUI. However, the estimation of the ultimate results of different laser treatments may be altered by different issues, such as patient selection, concomitant treatments, and long-term effect of vaginal laser thermotherapy. In the present paper, we present the protocol for a large multicenter study on the evaluation of the efficacy and safety of VEL for the treatment of GSM and SUI, the Vaginal Erbium Laser Academy Study (VELAS). This study will evaluate the effects of three laser applications in 1500 postmenopausal women. Subjective and objective symptoms will be evaluated prior to the first laser treatment with follow-up visits after 4 weeks from the last laser application, and subsequently after every 3 months for 1 year. Findings from the VELAS have the potential to affect clinical care practice and health decisions for millions of women world-wide for a non-hormonal treatment for GSM and a non-invasive treatment of SUI.

Reduction of postoperative adhesions with an auto-crosslinked hyaluronan gel in gynaecological laparoscopic surgery: a blinded, controlled, randomized, multicentre study.

BACKGROUND: Following myomectomy, postoperative adhesions occur in many patients with adverse effects on fertility. This study investigated the applicability, safety and efficacy of an auto-crosslinked hyaluronan gel in preventing adhesion formation after laparoscopic myomectomy. METHODS: Fifty-two patients aged 22-42 years, undergoing surgery at four centres, were randomly allocated to receive either the gel or no adhesion prevention. The incidence and severity of postoperative adhesions were assessed laparoscopically after 12-14 weeks in a blinded, scored fashion. The primary efficacy variable was the presence/absence of postoperative adhesions at second-look. RESULTS: A nonsignificantly higher proportion of patients receiving the gel were free from adhesions (13 of 21; 62%) compared with control patients (9 of 22; 41%), with a statistically significant difference between the severity of uterine adhesions at baseline and at second-look (0.3 +/- 0.9 versus 0.8 +/- 1.0, P < 0.05). In subjects undergoing myomectomy without concomitant surgery, the proportion of adhesion-free patients was 8 of 12 (67%) and 4 of 11 (36%) (not significant) in the gel and control groups, respectively, with a significant difference in the mean severity scores (P < 0.05). In subjects without uterine adhesions before myomectomy, 12 of 18 (67%) and 8 of 20 (40%) patients in the gel and control groups, respectively were adhesion-free (not significant), with a significant difference in the severity of uterine adhesions (P = 0.05). CONCLUSIONS: Our results suggest that the auto-crosslinked hyaluronan gel may have a favourable safety profile and efficacious antiadhesive action following laparoscopic myomectomy.

Pressure lavage under ultrasound guidance: a new approach for outpatient treatment of intrauterine adhesions.

OBJECTIVE: To present pressure lavage under ultrasound guidance (PLUG) as a new therapeutic procedure for selected cases of intrauterine adhesions (IUA). DESIGN: An open clinical investigation with no control group. SETTING: Teaching hospital. PATIENT(S): Seven consecutive patients referred to our department for secondary amenorrhea due to IUA. INTERVENTION(S): A newly developed technique based on sonohysterography was used to monitor the effects of intrauterine injections of saline solution on the continuous accumulation of saline in the uterine cavity for the mechanical disruption of IUA. MAIN OUTCOME MEASURE(S): Lysis of intrauterine adhesions, restoration of menses, and increased pregnancy rate in infertile patients. RESULT(S): Five patients with mild IUA obtained satisfactory lysis of adhesions by the use of the PLUG technique. A second-look hysteroscopy after 1 month showed that filmy adhesions persisted in two patients with moderate IUA. These adhesions were removed successfully during hysteroscopy. Restoration of menses was obtained and has continued in all patients. Two of the three infertile patients became pregnant. CONCLUSION(S): This technique is safe and ideal as an in-office procedure. PLUG allows complete lysis in mild IUA cases, and the need for therapeutic, and possibly follow-up hysteroscopy, can be avoided. In moderate IUA cases, the procedure may represent a useful initial step in reducing the need for operative hysteroscopy.

Intraoperative ultrasound guidance for operative hysteroscopy. A prospective study.

OBJECTIVE: To evaluate the efficacy and safety of ultrasound (US) guidance as compared to laparoscopic monitoring during operative hysteroscopy. STUDY DESIGN: Prospective, open study including 81 patients undergoing operative hysteroscopy under US guidance for uterine septum and submucous myoma. Clinical and surgical outcomes were compared with those in an historical control group of 45 patients undergoing the same operation under laparoscopic guidance. RESULTS: US guidance proved satisfactory in all patients, and there were no complications due to insufficient visualization of the pelvic structures; in no case was conversion to laparoscopic guidance required. US scanning was most useful in determining the outer limit of the intramural component of submucous partial intramural myoma, allowing complete resection. During metroplasty, US guidance allowed extension of the resection beyond the normal limit conventionally defined by hysteroscopy; none required reintervention. By comparison, in the control group, a second attempt was required because the operation was insufficiently radical in four patients. CONCLUSION: US guidance was used successfully as the only visual aid for hysteroscopic surgery, comparing favorably with laparoscopy in terms of efficacy and safety.

True incidence of vaginal vault prolapse. Thirteen years of experience.

OBJECTIVE: To assess the true incidence of vaginal vault prolapse after hysterectomy. STUDY DESIGN: The records of 2,670 patients who had undergone hysterectomy between 1983 and 1987 were reviewed. From this population, 448 patients were selected for follow-up study. The mean follow-up phase was 11 years (range, 9-13). Patients were divided into two groups according to the presence or the absence of genital prolapse at hysterectomy. Pelvic examination was performed in order to identify the presence of vault prolapse. Pelvic support was assessed using Baden and Walker's "halfway description." RESULTS: Five of the 2,670 patients who had undergone hysterectomy at our institution returned on their own initiative for surgical correction of vault prolapse. Using the modalities in the literature, the incidence of vault prolapse was 0.4%. Instead, on pelvic examination, the incidence of vault prolapse was 4.4% (20 patients in a group of 448). Fourteen of the 20 with vault prolapse had previously undergone vaginal hysterectomy for genital prolapse: six had had abdominal hysterectomy for benign disease, excluding genital prolapse. Therefore, the incidence of vaginal vault prolapse was 11.6% (14/120 patients) when hysterectomy had been performed for genital prolapse and 1.8% (6/328) when hysterectomy had been performed for other benign diseases. In the latter group (328 patients), all the cases of vault prolapse developed after abdominal hysterectomy: the incidence was 2% (6/308 patients); no case (0/20 patients) of vault prolapse developed after vaginal hysterectomy that had been performed on patients without genital prolapse. The primary risk factor for vaginal vault prolapse in this study, was obesity. Obese subjects were significantly more susceptible to developing the condition when compared to nonobese (P < .001). CONCLUSION: Our data show that there is a low incidence of vaginal vault prolapse when hysterectomy is performed in the absence of defects in pelvic support. A comparison of our method and those described in the literature to determine the incidence of vaginal vault prolapse showed that this event is often underevaluated if long-term follow-up after hysterectomy is not carried out.

Acute abdomen following dermoid cyst rupture during transvaginal ultrasonographically guided retrieval of oocytes.

We report a case of acute abdomen due to puncture of a dermoid cyst during oocyte aspiration, which required laparotomy. A woman who had undergone an in-vitro fertilization and embryo transfer required hospitalization due to onset of an acute abdomen. An ultrasonographic scan showed a pelvic mass with the features of dermoid cyst. The patient required diagnostic laparotomy which confirmed the presence of a ruptured dermoid cyst with subsequent peritonitis.

Ultrasound-guided hysteroscopic management of endometrial osseous metaplasia.

In the past, most cases of osseous metaplasia of the endometrium were diagnosed following removal of bone from the endometrium by dilatation and curettage and frequently subsequently treated by hysterectomy. Nowadays, management involves a suggested diagnosis by transvaginal ultrasound examination, confirmation by hysteroscopy and hysteroscopic removal of ectopic intrauterine bone. This is usually carried out under laparoscopic guidance. However, the degree of visual control provided by combined transabdominal and transrectal ultrasonography may prove sufficiently accurate for hysteroscopic guidance. In this report we describe a case of endometrial osseous metaplasia successfully managed by ultrasound-guided hysteroscopy. The advantages of our approach include reduced invasiveness, reduced costs and simultaneous visualization of the abdominal and intrauterine cavities. One limitation, however, is represented by the greater operator dependence of ultrasound guidance as compared to laparoscopy, the former requiring extensive training and state-of-the-art equipment. We suggest that ultrasound guidance for hysteroscopic removal of extensive osseous metaplasia may represent a potentially safer and more effective alternative to laparoscopy and would therefore encourage further clinical evaluation of this technique.

Expanded polytetrafluoroethylene surgical membrane in ovarian surgery on the rabbit. Biocompatibility, adhesion prevention properties and ability to preserve reproductive capacity.

OBJECTIVE: To evaluate the biocompatibility, adhesion prevention properties and ability to preserve reproductive capacity of polytetrafluoroethylene surgical membrane in ovarian surgery on the rabbit. STUDY DESIGN: In two groups of female rabbits a standard lesion was made on each ovary. In group 1, one ovary was partially covered with a flat sheet of the surgical membrane, and the other was left uncovered so that each rabbit served as its own control. In group 2, one ovary was again left uncovered to serve as an internal control, and the other was completely covered with a "cap" of the surgical membrane. Laparotomies were performed several weeks postoperatively after the rabbits were mated with fertile males; adhesions were evaluated, and the number of cornual pregnancies was determined. RESULTS: In group 1, 67.9% of the control ovaries and 7.1% of the partially covered ovaries had adhesions (P < .001); in the uterine horn on the control side, 32.1% of the rabbits exhibited cornual pregnancies (1.14 +/- 1.72 [mean +/- SD] pregnancies per rabbit), whereas on the experimental side, 89.3% of the rabbits exhibited cornual pregnancies (3.89 +/- 1.58 per rabbit). In group 2, 83.3% of the control ovaries and 11.1% of the covered ovaries had adhesions (P < .001); in the uterine horn on the control side, 23.5% of the rabbits exhibited cornual pregnancies (2 +/- 1.1 per rabbit), whereas on the experimental side, 100% of the rabbits exhibited cornual pregnancies (4.8 +/- 0.9 per rabbit). CONCLUSION: The surgical membrane is an excellent device for preventing the formation of adhesions to the ovary after surgery in rabbits, preserving the reproductive capacity of the ovary.

Massive vulvar edema in ovarian hyperstimulation syndrome. A case report.

BACKGROUND: Bilateral vulvar edema associated with severe ovarian hyperstimulation syndrome is described for the first time. CASE: A 28-year-old woman underwent gonadotropin-releasing hormone analogue and gonadotropin treatment for in vitro fertilization and embryo transfer. On day 18 of the cycle, the patient reported mild abdominal discomfort that became severe during the following four days. One the 22nd day of the cycle, bilateral ovarian enlargement and ascites were present. The vulva showed massive edema and fissures. Ovarian hyperstimulation syndrome (OHSS) therapy consisted of human albumin, lactated Ringer's solution and heparin. The vulvar edema was treated with topical hydrocortisone ointment, ice packs and topical gentamycin twice a day. After one week of treatment, the vulva was normal. CONCLUSION: We think that the vulvar edema in this case was the result of decreased oncotic pressure and increased hydrostatic pressure, as occur during OHSS.

Clinical and histologic effects of topical treatments of vulval lichen sclerosus. A critical evaluation.

A randomized study was conducted on 79 patients with vulval lichen sclerosus who were treated for three months with four topical drugs including testosterone (2%), progesterone (2%), clobetasol propionate (.05%) and a cream based preparation. To evaluate the efficacy of the treatments, patients were examined before and after therapy for symptoms, gross appearance of the lesions and histopathologic features. Patients treated with clobetasol had a better response than responses recorded in the other groups. Remission of symptoms occurred in 75% of patients treated with clobetasol compared to 20% treated with testosterone, 10% treated with progesterone and 10% treated with a cream based preparation. The clobetasol group was the only group with gross changes and histologic evaluations before and after treatment, that showed a highly significant difference (P < .001). In a condition characterized by epidermal atrophy, we observed a significant reduction in epidermal atrophy after treatment. This study suggests that clobetasol propionate (.05%) (a very potent topical steroid) is the therapy of choice in vulval lichen sclerosus.

[Clobetasol vs. testosterone in the treatment of lichen sclerosus of the vulvar region]. / Clobetasolo vs testosterone nel trattamento del lichen scleroso della regione vulvare.

The paper describes a study carried out in 40 patients affected by lichen sclerosus (LS) of the vulva. The mean age of patients was 60.9 years (range 27-83) and 31 were in menopause. Patients were divided randomly into two groups of 20. The symptoms (itching, burning, pain, dyspareunia), clinical aspects (atrophy, hyperkeratosis, sclerosis) and histological alterations (atrophy of the epithelium, edema, inflammatory infiltrate, fibrosis) were quantified in each patient by a score. The mean scores relating to the three parameters examined were then calculated for each group. One group was treated with testosterone propionate 2% and the other with a strong synthetic corticosteroid, clobetasol dipropionate 0.05%. After 24 weeks of treatment patients were again evaluated in relation to clinical (symptoms and clinical aspects) and histological parameters, following the procedure used before the start of treatment. The mean scores obtained were then compared with those before the start of treatment. Statistical analyses were performed using Student's t-test. Testosterone was found to be effective in relation to symptoms but no significant change was observed in relation to clinical aspects and histological alterations. It also caused major secondary effects which led to the suspension of treatment in one patient. Clobetasol was shown to be highly effective both in relation to symptoms and in terms of clinical aspects and histological alterations, and did not cause any noteworthy collateral effects, especially contact dermatitis. In the context of the objective parameters examined in this study, sclerosis and hyperkeratosis were easily modified by corticosteroid treatment in comparison to atrophy, especially in those patients with a longer duration of disease.(ABSTRACT TRUNCATED AT 250 WORDS)

[Benzidamine in the topical treatment of vaginitis caused by Gardnerella vaginalis]. / La benzidamina nel trattamento topico della vaginite da Gardnerella vaginalis.

The present clinical trial has been carried out in order to evaluate the efficacy of benzydamine in treatment of vaginitis caused by Gardnerella vaginalis. Fifty women affected by this specific pathology have been submitted to topical treatment with 0.5% benzydamine vaginal cream. The treatment has been carried out for 9 consecutive days using a local application of benzydamine twice a day. The clinical result was evaluated after 12 and 60 days. The following parameters were taken into consideration: symptoms (leucorrhea, itching, burning), clinical signs (oedema, hyperemia, vaginal secretion), instrumental data (pH, colposcopy, sniff test) and microbiological findings (searching of clue cells, Lactobacillus and Gardnerella vaginalis). At the first check point after 12 days 84% of patients have been considered healed; at the second check the percentage of healing rose to 92%. Therefore benzydamine was considered highly effective in 92% of vaginitis caused by Gardnerella vaginalis.

Lichen sclerosus and squamous hyperplasia of the vulva. A clinical study of medical treatment.

One hundred thirty-eight cases of nonneoplastic epithelial disorders of the vulva treated with medical therapy from 1984 to 1988 were evaluated at the University of Florence, Florence, Italy. The 67 cases of lichen sclerosus were treated with testosterone propionate or progesterone ointment for 32 weeks. The 31 cases of squamous hyperplasia were treated with corticosteroid ointment for 16 weeks. The 40 patients with lichen sclerosus associated with squamous hyperplasia were treated with corticosteroid ointment for 12 weeks and then with testosterone propionate ointment for another 20. To evaluate the efficacy of the treatments, the patients were examined before and after therapy. The evaluation took into account the symptoms and gross appearance of the lesions, which were given a score of 1-3. Considering all the cases evaluated, a total regression of symptoms occurred in 82 patients (59.4%), while a partial regression occurred in 37 (26.8%). Furthermore, there was a total regression of gross changes in 68 cases (49.3%) and a partial one in 43 (31.1%). The best results were obtained with squamous hyperplasia, which lichen sclerosus, alone or associated with squamous hyperplasia, yielded less successful results.

[Viral infections and neoplasms of the uterine cervix]. / Infezioni virali e neoplasia della cervice uterina.

Since the last century, epidemiological studies of cervical carcinoma have shown a close link with sexual activity and in particular with promiscuity starting at an early age. Aetiological research has therefore concentrated on identifying sexually transmitted pathogens. In recent years studies have focused on the apparently significant role of HSV and particularly HPV in the aetiopathogenesis of this tumour. After the first cytohistological findings the HPV-cervical cancer link has been confirmed by electron microscopy, immunohistochemical studies and hybridisation of viral DNA. The identification of different HPV types presenting varying degrees of oncogenic risk offers the prospect of reaching a reliable prognosis on the basis of the particular virus identified in the lesion. The hypothesis that the virus has a decisive influence on the biology of th tumour is also intriguing: findings on the incidence and course of cervical cancer in the youngest women seems to suggest tha HPV may be a fundamental tumour growth factor.

[Use of topical methisoprinol (Viruxan) in female genital condylomatosis]. / Utilizzazione del metisoprinolo (Viruxan) per via topica nella condilomatosi genitale femminile.

Medical therapy of genital condylomatosis seems to be the most rational strategy, since this pathology is characterised by highly frequent recurrences after destructive physical therapy alone. Successful therapy of female genital condylomatosis with methisoprinol (Viruxan), administered as ointment and/or vaginal ovules is reported. The drug proved to be efficient both in curing this viral infection and preventing its recurrences.