Cultural Beliefs, Perceptions, and Experiences on Female Genital Mutilation Among Women and Men: A Qualitative Analysis.

The practice of female genital mutilation (FGM) is a deeply-rooted tradition that affects predominantly regions of Africa and Asia. Because of migration flows, FGM is an issue of increasing concern worldwide. FGM is now carried out in Europe, North America, Australia and New Zealand, and more specifically among immigrant communities from countries where it is common. This study aims to assess the experience, knowledge, attitudes, and beliefs related to FGM of migrant women and men from FGM-affected countries residing in Spain and the United Kingdom. A phenomenological qualitative approach was used. Participants (n=23) were recruited by using the snowball sampling technique until data saturation was reached. Data were collected through 18 open-ended interviews and a focus group. Of the 23 participants, 20 women had undergone FGM. The following five themes were generated from interviews: (a) FGM practice development, (b) knowledge about the practice, (c) reasons for performing FGM, (d) attitudes toward continuing or abandoning the practice, and (e) criminalization of FGM. The study here presented identifies a lack of information, memory, and knowledge about the practice of FGM and typology among women with FGM. The justification of the practice seems to be based on a multifactorial model, where sociocultural and economic factors, sexual factors, hygienic-esthetic factors, and religious-spiritual factors take on a greater role in the analysis of the interviews carried out. The participants practically unanimously agree to advocate the abandonment and eradication of this harmful traditional practice. The knowledge displayed in this study may provide a basis for improving awareness and healthcare in such collectives, aiming the eradication of this harmful traditional practice.

Rationale and design of ASTEROID 2, a randomized, placebo- and active comparator-controlled study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids.

BACKGROUND: Uterine fibroids (UFs) may be treated with progesterone receptor modulators (PRMs), which have been shown to reduce heavy menstrual bleeding and the size of UFs. To date, one PRM (ulipristal acetate) has received regulatory approval for the treatment of UFs; therapy comprises intermittent treatment courses of up to 3months each, followed by a break to allow two menstruations to occur. We report the design of ASTEROID (Assess Safety and efficacy of vilaprisan in patients with uTERine fibrOIDs) 2, a phase 2 study examining the efficacy and safety of a novel PRM, vilaprisan, in women with UFs. METHODS/DESIGN: In this randomized multi-arm study, vilaprisan (2mg daily) will be administered in different regimens: continuous treatment for 12 or 24weeks, or two 12-week treatment periods separated by a break to allow one menstruation to occur. Efficacy and safety will be compared with that of ulipristal acetate (5mg daily) and placebo. Patients randomized to receive placebo for 12weeks will also be given active treatment for 12weeks. The primary measure of efficacy will be amenorrhoea rate; secondary measures include time to normalized menstrual bleeding and percentage change in UF volume. Endometrial changes will be monitored throughout the study. DISCUSSION: The placebo- and active comparator-controlled trial ASTEROID 2 is the first study to evaluate systematically the efficacy and safety of different treatment regimens of PRMs in women with UFs. The findings of this study will direct the planning of future clinical trials of vilaprisan.

Unprotected carotid artery stenting in symptomatic elderly patients: a single-center experience.

BACKGROUND AND PURPOSE: Surgery is known to have fewer adverse events in patients aged >75 years with carotid stenosis, but some are not candidates due to comorbidity. Stenting using protection devices is the most accepted endovascular technique. Our aim is to show the safety and efficacy of carotid stenting without any protection device in these patients. MATERIAL AND METHODS: All patients older than 75 years with carotid stenosis treated in our center between January 2002 and December 2012 were included in this prospective study. All were treated by carotid stenting without protection devices. Angiographic results, neurologic complications and Doppler ultrasound were collected during the procedure and within 30 days. RESULTS: 49 patients were included (mean age 78.2 years, range 75-86). The average degree of stenosis was 88.2%. During the procedure there were two cases of transient ischemic attack and one intraparenchymal hemorrhage. At 30 days there was a non-disabling stroke. The combined rate of disabling stroke plus myocardial infarction plus death was 6% at 30 days and the rate of any stroke was 4% during the procedure and 2% at 30 days. CONCLUSIONS: Endovascular treatment of carotid stenosis without protection devices in symptomatic patients aged >75 years is an alternative to endovascular treatment with protection devices. Complications and mortality rates are similar to studies that used protection devices in lower risk patients.