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- Ospemifene: first global approval. [Journal Article]
- Drugs 2013 May; 73(6):605-12.
Ospemifene (Osphena™) is an oral selective estrogen receptor modulator (SERM), with tissue-specific estrogenic agonist/antagonist effects. QuatRx Pharmaceuticals conducted the global development of the agent before licensing it to Shionogi for regulatory filing and commercialization worldwide. Ospemifene is the first non-estrogen treatment approved for moderate to severe dyspareunia in women with menopause-related vulvar and vaginal atrophy. The drug is approved in the USA, and application for EU regulatory approval is underway. This article summarizes the milestones in the development of ospemifene leading to this first approval for moderate to severe dyspareunia, a symptom of postmenopausal vulvar and vaginal atrophy.
- Body Image and Genital Self-image in Pre-menopausal Women with Dyspareunia. [JOURNAL ARTICLE]
- Arch Sex Behav 2013 Apr 19.
With a prevalence of 15-21 %, dyspareunia is one of the most commonly reported sexual dysfunctions in pre-menopausal women under the age of 40. Studies to date have focused primarily on clinical samples, showing that women with dyspareunia report overall sexual impairment, anxiety, and feelings of sexual inadequacy. However, little is known about their body image and genital self-image and few studies have sampled women exclusively from the general population. The aim of the present, controlled study was to investigate body image and genital self-image in a community sample of pre-menopausal women with self-reported dyspareunia. In total, 330 women completed an online survey, of which 192 (58 %) had dyspareunia and 138 (42 %) were pain-free control women. In comparison to pain-free control women, women with dyspareunia reported significantly more distress about their body image and a more negative genital self-image. Moreover, findings from a logistic regression, in which trait anxiety was controlled for, showed that a more negative genital self-image was strongly and independently associated with an increased likelihood of reporting dyspareunia. These results suggest that, in women with dyspareunia, body image and genital self-image are significantly poorer and would benefit from more attention from both clinicians and researchers.
- Endometriosis and cancer: what do we know? [Journal Article]
- Minerva Ginecol 2013 Apr; 65(2):167-79.
Endometriosis is the presence of endometriotic tissue outside of the uterus, composed of endometriotic glands and stroma. It affects between 10% to 12% of women in reproductive age. It presents with dysmenorrhea, dyspareunia, chronic pelvic pain, infertility, urinary or digestive symptoms. Diagnosis is based on clinical suspicion, clinical exam, pelvic ultrasound or pelvic magnetic resonance, and confirmed by laparoscopy with pathology studies. Its management is better understood nowadays. However, its association with neoplasia has been questioned for many years. It probably plays a role in the etiology of gynecological cancers, mainly ovarian neoplasia. In our review, we separately compared endometriosis and endometrioma to cancer, in terms of mutual causality, common risk factors, distinction based on histological findings, in addition to molecular and genetic pathways behind this association. This article reviews the English literature for studies on the association between endometriosis and gynecological cancers. Additional reports were collected by systematically reviewing all references from retrieved papers.
- Surgical management of endometriosis. [Journal Article]
- Minerva Ginecol 2013 Apr; 65(2):113-23.
Endometriosis is a complex disease of young women in reproductive age. It's responsible for dysmenorrhea, dyspareunia, chronic pelvic pain and infertility. Medical and surgical treatments have different aims. Hormonal suppression tends to stop natural evolution of the disease and surgery enables macroscopic excisions of endometriotic implants. Outcomes depend on the stage and the preoperative symptoms. This article summarizes a review of surgical management of endometriosis describing surgical indications, techniques, and outcomes in terms of pain and fertility.
- Fertility preservation options in women with endometriosis. [Journal Article]
- Minerva Ginecol 2013 Apr; 65(2):99-103.
Endometriosis is a common, chronic condition in reproductive age women. Although some women may be asymptomatic, most women present with dysmenorrhea, dyspareunia, pelvic pain and/or infertility. Despite the fact that a causal relationship between endometriosis and infertility has not been clearly established, the fecundity rate of untreated women with endometriosis is lower than normal couples. However, suppressive medical therapy for endometriosis has not been shown to improve fecundity rates and may only result in a delay in the use of more effective treatments to achieve pregnancy. In the other hand, surgery for severe endometriosis can be useful to treat infertile women, but several studies reported a lower ovarian reserve after excision of ovarian endometriomas, due to incidental excision of normal ovarian tissue together with the endometrioma wall. Therefore, fertility preservation procedures should be considered to reproductive-age women at risk of impaired fertility related to endometriosis progression or endometriosis surgical treatment. The purpose of this document was to review the current literature regarding fertility preservation techniques for patients diagnosed with endometriosis.
- Suprapubic cartilaginous cyst - A case report. [Journal Article]
- Australas Med J 2013; 6(3):126-8.
Suprapubic cartilaginous cyst (SPCC) is a rare condition known to occur in postmenopausal multiparous women. It is due to the degeneration of the pubic symphysis. Due to its slow progression and rarity in occurrence, it is often misdiagnosed. Presentation includes a painless mass in the suprapubic region, urinary retention, recurrent urinary tract infections, dysuria and dyspareunia. Knowledge of this condition is of great importance, as this is a benign condition that is managed conservatively, thereby avoiding unnecessary procedures. Surgical resection has not shown to have any additional benefit. Once suspected, MRI is ideal for diagnosis. This case report discusses a SPCC with punctuate calcifications and a locule of gas within it. This is the first documented case of a SPCC with punctuate calcifications.
- Clinical Outcome After Radical Excision of Moderate-Severe Endometriosis With or Without Bowel Resection and Reanastomosis: A Prospective Cohort Study. [JOURNAL ARTICLE]
- Ann Surg 2013 Apr 10.
OBJECTIVE::To assess the clinical outcome of women requiring laparoscopic excision of moderate-severe endometriosis in women with and without bowel resection and reanastomosis.
METHODS::Two hundred three patients with laparoscopically excised moderate (n = 67) or severe (n = 136) endometriosis (rAFS: revised endometriosis classification of the American Fertility Society) were prospectively followed during a median of 20 months (1-45 months) using a CONSORT-inspired checklist. Patients completed the EHP30 Quality-of-Life Questionnaire and visual analogue scales (VAS) for dysmenorrhea, chronic pelvic pain, and deep dyspareunia and answered questions about postoperative complications, reinterventions/recurrences, and fertility outcome 1 month before and 6, 12, 18, and 24 months after surgery. Clinical outcome was compared between women with deeply infiltrative endometriosis undergoing CO2 laser ablative surgery with bowel resection (study group, 76/203; 37%) and without bowel resection (control group, 127/203; 63%).
RESULTS::Both groups were similar with respect to population characteristics and clinical outcome, except for mean rAFS score [higher in study group (73 ± 31) than in control group (48 ± 26)] and minor complication rate [higher in study group (11%) than in control group (1%)]. In both groups, mean VAS and EHP30 scores improved significantly and remained stable for 24 months after surgery, with a pregnancy rate of 51%. Within 1, 2, and 3 years follow-up, the cumulative reintervention rate was 1%, 7%, and 10%, respectively, and the cumulative endometriosis recurrence rate was 1%, 6%, and 8%, respectively.
CONCLUSIONS::Clinical outcome after CO2 laser laparoscopic excision of moderate-severe endometriosis was comparable in women with or without bowel resection and reanastomosis, except for a higher minor complication rate occurring in women with bowel resection and reanastomosis (NCT00463398).
- Bidirectional barbed suture in total laparoscopic hysterectomy and lymph node dissection for endometrial cancer: technical evaluation and 1-year follow-up of 61 patients. [Journal Article]
- J Laparoendosc Adv Surg Tech A 2013 Apr; 23(4):347-50.
This randomized clinical study compared the feasibility and safety of the shortest suture for bidirectional knotless barbed versus standard sutures, with either extracorporeal or intracorporeal knots, for vaginal cuff closure following total laparoscopic hysterectomy (TLH) and lymph node dissection for early endometrial cancer.The study design was Canadian Task Force Classification I. In tertiary-care university-based teaching hospitals, 61 women underwent TLH and lymph node dissection. In accord with randomization, the vaginal cuff in TLH was closed with either extracorporeal or intracorporeal knots (1-Monocryl(®); Ethicon Inc., Somerville, NJ) and a bidirectional knotless barbed suture (0-Quill™; Angiotech Pharmaceuticals, Inc., Vancouver, BC, Canada). All patients were evaluated at 3-month, 6-month, and 1-year follow-up.Time required to suture was significantly lower in the group treated with bidirectional suture than in groups with traditional sutures (P<.001). No significant difference was observed in the operative time between the study groups. The degree of surgical difficulty was significantly lower in the bidirectional barbed suture group than in the other groups. At 1-year follow-up all patients presented no wound dehiscence, no bleeding, dyspareunia, and other potential major complications such as ureteric, bladder, or bowel injury.Use of a barbed suture reduces the time required to repair the vaginal cuff during TLH. At follow-up of patients, carried out 3 months, 6 months, and 1 year after the surgery, no wound dehiscence, no bleeding, or no other potential major surgical complications had occurred.
- Combined Surgical and Hormone Therapy for Endometriosis Is the Most Effective Treatment: Prospective, Randomized, Controlled Trial. [JOURNAL ARTICLE]
- J Minim Invasive Gynecol 2013 Apr 5.
STUDY OBJECTIVE:To evaluate 3 therapy strategies: hormone therapy, surgery, and combined treatment.
DESIGN:Prospective, randomized, controlled study (Canadian Task Force classification I).
SETTING:University-based teaching hospital.
PATIENTS:Four hundred fifty patients with genital endometriosis, aged 18 to 44 years, before first laparoscopy.
INTERVENTIONS:Patients were randomly assigned to 1 of 3 treatment groups: hormone therapy, surgery, or combined treatment. Patients were reevaluated at second-look laparoscopy, at 2 to 2 months after 3-month hormone therapy in groups 1 and 3 and at 5 to 6 months in group 2 (surgical treatment alone). Outcome data were focussed on the endometriosis stage, recurrence of symptoms, and pregnancy rate.
MEASUREMENTS AND MAIN RESULTS:All treatment options, independent of the initial Endoscopic Endometriosis Classification stage, achieved an overall cure rate of ≥50%. A cure rate of 60% was achieved with the combined treatment, 55% with exclusively hormone therapy, and 50% with exclusively surgical treatment. Recurrence of symptoms was lowest in patients who received combined treatment. Significant benefit was achieved for dysmenorrhea and dyspareunia. An overall pregnancy rate of 55% to 65% was achieved, with no significant difference between the therapeutic options.
CONCLUSION:In the quest to find the most effective treatment of genital endometriosis, this clinical randomized study shows the lowest incidence of recurrence with combined surgical and medical treatment and improved pregnancy rate in any medically treated patients with or without surgery. The highest cure rate (Endoscopic Endometriosis Classification stage 0) for endometriosis was also achieved in the combined treatment group.
- Risk of recurrence, subsequent mode of birth and morbidity for women who experienced severe perineal trauma in a first birth in New South Wales between 2000 -2008: a population based data linkage study. [Journal Article]
- BMC Pregnancy Childbirth 2013.:89.
Severe perineal trauma occurs in 0.5-10% of vaginal births and can result in significant morbidity including pain, dyspareunia and faecal incontinence. The aim of this study is to determine the risk of recurrence, subsequent mode of birth and morbidity for women who experienced severe perineal trauma during their first birth in New South Wales (NSW) between 2000 - 2008.All singleton births recorded in the NSW Midwives Data Collection between 2000-2008 (n=510,006) linked to Admitted Patient Data were analysed. Determination of morbidity was based upon readmission to hospital within a 12 month time period following birth for a surgical procedure falling within four categories: 1. Vaginal repair, 2. Fistula repair, 3. Faecal and urinary incontinence repair, and 4. Rectal/anal repair. Women who experienced severe perineal trauma during their first birth were compared to women who did not.2,784 (1.6%) primiparous women experienced severe perineal trauma during this period. Primiparous women experiencing severe perineal trauma were less likely to have a subsequent birth (56% vs 53%) compared to those not who did not (OR 0.9; CI 0.81-0.99), however there was no difference in the subsequent rate of elective caesarean section (OR 1.2; 0.95-1.54), vaginal birth (including instrumental birth) (OR 1.0; CI 0.81-1.17) or normal vaginal birth (excluding instrumental birth) (OR 1.0; CI 0.85-1.17). Women were no more likely to have a severe perineal tear in the second birth if they experienced this in the first (OR 0.9; CI 0.67-1.34). Women who had a severe perineal tear in their first birth were significantly more likely to have an 'associated surgical procedure' within the ≤12 months following birth (vaginal repair following primary repair, rectal/anal repair following primary repair, fistula repair and urinary/faecal incontinence repair) (OR 7.6; CI 6.21-9.22). Women who gave birth in a private hospital compared to a public hospital were more likely to have an 'associated surgical procedure' in the 12 months following the birth (OR 1.8; CI 1.54-1.97), regardless of parity, birth type and perineal status.Primiparous women who experience severe perineal trauma are less likely to have a subsequent baby, more likely to have a related surgical procedure in the 12 months following the birth and no more likely to have an operative birth or another severe perineal tear in a subsequent birth. Women giving birth in a private hospital are more likely to have an associated surgical procedure in the 12 months following birth.