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- The clinical relevance of the effect of ospemifene on symptoms of vulvar and vaginal atrophy. [JOURNAL ARTICLE]
- Climacteric 2014 Oct 21.:1-15.
Abstract Objectives To explore clinically relevant differences in severity of vulvar and vaginal atrophy (VVA) in postmenopausal women treated with ospemifene compared with placebo. Methods Analysis of two multicentre, randomised, double-blind 12-week phase III studies in postmenopausal women (40-80 years, with VVA, treated with ospemifene 60 mg/day or placebo [Study 310 and Study 821]). Severity of vaginal dryness and dyspareunia were evaluated using a four-point scoring system and clinically relevant differences between ospemifene and placebo were analysed and are presented as improvement (reduction in ≥1 unit on four-point scoring system), substantial improvement (reduction in 2-3 units on four-point scoring system) and relief (severity score of mild/none after 12 weeks). Results In Study 310, significantly more women with a most bothersome symptom of dyspareunia had improvement (68.3% vs 54.1%; p=0.0255) or relief (57.5% vs 41.8%; p=0.0205) in the severity of dyspareunia from baseline to Week 12 with ospemifene compared with placebo. For those with a most bothersome symptom of vaginal dryness, significantly more experienced improvement (74.6% vs 57.7%; p=0.0101), substantial improvement (42.4% vs 26.9%; p=0.0172) and relief (66.1% vs 49.0%; p=0.0140) of vaginal dryness from baseline to Week 12 with ospemifene compared with placebo. Proportions of women with improvement/substantial improvement/relief of symptoms of vaginal dryness or dyspareunia were similar in Study 821. Clinically relevant differences were noticeable by Week 4. Conclusions Treatment with ospemifene was consistently associated with greater improvement, substantial improvement or relief in the severity of the most bothersome symptoms of vaginal dryness or dyspareunia compared with placebo. NCT registration numbers: NCT00276094, NCT00729469.
- Sexual function after fractional microablative CO2 laser in women with vulvovaginal atrophy. [JOURNAL ARTICLE]
- Climacteric 2014 Oct 21.:1-21.
ABSTRACT Objective: To investigate the effects of fractional CO2 laser on sexual function and overall satisfaction with sexual life in postmenopausal women with vulvo-vaginal atrophy (VVA). Methods: This prospective study included 77 postmenopausal women (mean age: 60.6 ± 6.2 years) treated for VVA symptoms with fractional microablative CO2 laser system (SmartXide(2) V(2)LR, Monalisa Touch, DEKA, Florence, Italy). Sexual function and quality of life (QoL) were evaluated with the Female Sexual Function Index (FSFI) and the Short Form 12 (SF-12) respectively both at baseline and at 12-week follow-up. A 10-mm visual analogue scale (VAS) was used to measure the overall satisfaction with sexual life and the intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia and dysuria) before and after the study period. Results: we observed a significant improvement in the total and each specific domain FSFI scores at 12-week follow-up compared to baseline (p < 0.001). After concluding the laser treatment the overall satisfaction with sexual life significantly improved (p<0.001). Seventeen (85%) out of 20 (26%) women not sexually active for VVA severity at baseline, regained a normal sexual life at 12-week follow-up. Finally, we also found a significant improvement in each VVA symptom (p<0.001) and in QoL evaluation, both for the physical (p=0.013) and mental (p=0.002) domains' scores. Conclusions: Fractional microablative CO2 laser is associated with a significant improvement of sexual function and satisfaction with sexual life in postmenopausal women with VVA symptoms.
- Psychological Treatment for Vaginal Pain: Does Etiology Matter? A Systematic Review and Meta-Analysis. [JOURNAL ARTICLE]
- J Sex Med 2014 Oct 20.
Classification of vaginal pain within medical or psychiatric diagnostic systems draws mainly on the presumed presence or absence (respectively) of underlying medical etiology. A focus on the experience of pain, rather than etiology, emphasizes common ground in the aims of treatment to improve pain and sexual, emotional, and cognitive experience. Thus, exploring how vaginal pain conditions with varying etiology respond to psychological treatment could cast light on the extent to which they are the same or distinct.To examine the combined and relative efficacy of psychological treatments for vaginal pain conditions.A systematic search of EMBASE, MEDLINE, PsycINFO, and CINAHL was undertaken. Eleven randomized controlled trials were entered into a meta-analysis, and standardized mean differences and odds ratios were calculated. Effect sizes for individual psychological trial arms were also calculated.Main outcome measures were pain and sexual function.Equivalent effects were found for psychological and medical treatments. Effect sizes for psychological treatment arms were comparable across vaginal pain conditions.Effectiveness was equivalent regardless of presumed medical or psychiatric etiology, indicating that presumed etiology may not be helpful in selecting treatment. Research recommendations and clinical implications are discussed. Flanagan E, Herron KA, O'Driscoll C, and Williams AC de C. Psychological treatment for vaginal pain: Does etiology matter? A systematic review and meta-analysis. J Sex Med **;**:**-**.
- Factors associated with sexual dysfunction; a population based study in Iranian reproductive age women. [Journal Article]
- Arch Iran Med 2014 Oct; 17(10):679-84.
Sexual function results from complex interactions of neurovascular and endocrine factors. The prevalence of sexual dysfunction varies in different countries. This study aimed to determine the prevalence of sexual dysfunction and the related factors among reproductive age women in Iran.A community-based cross-sectional descriptive study was carried out on 784 married women living in urban areas of 4 provinces of Iran. Participants were recruited using a stratified, multistage probability cluster sampling method. Female sexual function was assessed using the Female sexual function index questionnaire. Data was analyzed using Spearman and logistic regression tests.The results demonstrated 27.3% prevalence of sexual dysfunction including 0.8% severe, 20.3% moderate, and 6.3% mild sexual dysfunction. Among women with sexual dysfunction, the frequency of desire, arousal, lubrication, and orgasmic disorders were 35.6%, 39.9%, 18.9%, and 27.3%, respectively. Dyspareunia was reported by 56.1% of women. Among the participants, 15.2% were unsatisfied with their sexual life. There was a statistically significant relationship between sexual dysfunction and duration of married life, perceived attraction of spouse, overall satisfaction with routine life and the women's ability to express their sexual desires. Sexual dysfunction is prevalent among Iranian women. A comprehensive service including counseling programs for sexual dysfunction at primary health care is highly recommended.
- Morbidity and functional mid-term outcomes using Prolift pelvic floor repair systems. [Journal Article]
- Can Urol Assoc J 2014 Sep; 8(9-10):E605-9.
We assess midterm morbidity and functional outcomes using the Prolift (Gynecare/Ethicon, Somerville, NJ) system and identify potential related risk factors. The Prolift mesh system to treat genital prolapse was introduced in 2005. It was withdrawn from the market in early 2013 after rising doubts about safety.Over a 7-year period, we retrospectively analyzed a cohort of 112 consecutive patients who underwent the Prolift procedure since 2006. Intraoperative and postoperative complications, anatomical and functional outcomes were recorded.The median follow-up was 49.5 months (range: 16-85). The mean age was 64.7 ± 10.9 years (range: 40-86). Of the 112 patients, 74 patients had stage 3 (66.1%) and 8 patients had stage 4 (7.14%) vaginal prolapse. Prolift surgery was performed for pro-lapse recurrence for 26 patients (23.2%). Total mesh was used in 32 patients (29%), an isolated anterior mesh in 57 patients (51%) and an isolated posterior mesh in 23 patients (21%). Concomitant surgical procedures were performed for 44 patients (39.3%). Overall, 72% (18/25) of the complications were managed medically. We reported a failure rate of 8% (n = 9) occurring after a median follow-up of 9.5 months (range: 1-45). Among the 64 patients who had preoperative sexual activity (57.1%), de novo dyspareunia occurred in 9 patients (16.07%). We extracted predictive factors concerning failure, complications and sexuality.Despite its market withdrawal, the Prolift system was associated with good midterm anatomic outcomes and few severe complications. Long-term follow-up data are still lacking, but surgeons and patients may be reassured.
- Relating historical variables at first presentation with operative findings at laparoscopy for endometriosis. [Journal Article]
- Aust N Z J Obstet Gynaecol 2014 Oct; 54(5):480-6.
To determine the correlation between historical variables at presentation with the phenotype and location of biopsy proven endometriosis at laparoscopy.Prospective observational study. Consecutive women had laparoscopic surgery following clinical suspicion of endometriosis. Standardised history and clinical examination were taken, and the presenting complaints were evaluated within four subsets of women: (i) primary laparoscopy for endometriosis (ii) previous laparoscopically confirmed endometriosis (iii) biopsy positive for endometriosis and (iv) all biopsies negative for endometriosis. Historical pain variables within the four subsets were compared with disease location and phenotype (superficial, deep infiltrating, endometriomata) at laparoscopy. A stringent P-value of 0.01 was used as the cut-off for significance.Overall 104 consecutive women were included: mean age 34.3 years, 66/104 (63.5%) had reoperation and 38/104 (36.5%) had primary laparoscopy. 89/104 (85.6%) were biopsy positive for endometriosis, and 11/104 (10.6%) were biopsy negative. Superficial endometriosis was most common phenotype. Site of pain did not correlate with ipsilateral location of disease. Significant correlations included as follows: dyspareunia and endometrioma (P = 0.0009) in women undergoing reoperation; dyspareunia and posterior compartment (P = 0.0086) and lateral compartment (P = 0.0004) disease in women with histology proven endometriosis; left iliac fossa pain and biopsy proven posterior compartment endometriosis (P = 0.0041).Although a history of dyspareunia in women with previous endometriosis was significantly correlated with endometrioma, site-specific locations of pain symptoms did not correlate with ipsilateral locations of endometriosis at laparoscopy. The phenotype - combined deep and superficial endometriosis - was associated with dyspareunia among women with previous history of endometriosis.
- Transvaginal single-incision mesh reconstruction for recurrent or advanced anterior vaginal wall prolapse. [JOURNAL ARTICLE]
- Arch Gynecol Obstet 2014 Oct 4.
Single-incision transvaginal mesh for reconstruction of Level I and II prolapses in women with recurrent or advanced prolapse. We evaluated functional, anatomical, sonomorphological and quality-of-life outcome.Data were collected retrospectively for preoperative parameters and at follow-up visits. Anatomical cure was assessed with vaginal examination using the ICS-POP-Q system; introital-ultrasound scan for postvoidal residual and description of mesh characteristics was performed. We applied a visual analogue scale (VAS) and the German Pelvic Floor Questionnaire to assess quality-of-life.Seventy women with cystocele (III: 61.3 %/IV: 16 %), all post-hysterectomy and in majority (81.4 %) after previous cystocele repair, were operated using a single-incision transvaginal technique. Overall anatomical success rate was 95.7 % with significant improvement in quality-of-life (p < 0.0001). Mesh erosion occurred in 5.7 %, one patient presented symptomatic vaginal vault prolapse. Postvoidal residual declined significantly (58 vs. 2.9 %). Sonographic mesh length was 55.7 % of implanted mesh with a wide range of mesh position, but no signs of mesh dislocation. There was no de novo dyspareunia reported, one case of preoperative existing dyspareunia worsened. No severe adverse event was observed.We hereby present a trial of a high-risk group of patients requiring reconstruction of anterior and apical vaginal wall in mostly recurrent prolapse situation. Our data support the hypothesis of improved anatomical and functional results and less mesh shrinkage caused by the single-incision technique with fixation in sacrospinous ligament in combination with modification in mesh quality compared to former multi-incision techniques.
- A systematic review and meta-analysis of the impact of native tissue repair for pelvic organ prolapse on sexual function. [JOURNAL ARTICLE]
- Int Urogynecol J 2014 Oct 2.
The aim of this review was to investigate the impact of native tissue repair for pelvic organ prolapse (POP) on overall sexual function and dyspareunia.Cochrane Incontinence Group Specialized Register of Controlled Trials, The Cochrane Central Register of Controlled Trials, MEDLINE, and Embase were searched for trials of prolapse surgery assessing sexual function and dyspareunia before and after surgery. We assessed observational studies and randomized controlled trials investigating the impact of surgical correction of POP on sexual function. Surgical interventions assessed were anterior and/or posterior repair with or without a vaginal hysterectomy. Studies including patients undergoing concurrent incontinence surgery or vaginal mesh insertion were excluded from the analysis. Dyspareunia was analyzed separately.We identified 674 potential citations, of which 14 articles assessed sexual function and/or dyspareunia before and after traditional prolapse surgery. The results suggest evidence for significant improvement in sexual function postsurgery, with a standardized mean difference of -0.55, 95 % confidence interval (CI) -0.68 to -0.43 in favor of surgical correction. Dyspareunia rates were also significantly improved postoperatively, with overall odds ratio of at least 2.5 times as likely as the chances of deterioration.Sexual function is significantly improved and dyspareunia significantly reduced following native tissue prolapse surgery. There were several methodological problems with the quality of the primary research, particularly related to study heterogeneity, use of different outcome measures, and absence of well-designed randomized controlled trials.
- Perceptions of dyspareunia in postmenopausal women with vulvar and vaginal atrophy: findings from the REVIVE survey. [Journal Article]
- Womens Health (Lond Engl) 2014 Jul; 10(4):445-54.
Symptoms of vulvar and vaginal atrophy (VVA), including dyspareunia and vaginal dryness, have a distinct negative impact on a woman's quality of life. The REVIVE survey highlighted the lack of awareness of VVA symptoms among postmenopausal women with vaginal symptoms, with many women reluctant to initiate discussions with their healthcare professionals despite the presence of vaginal symptoms. The REVIVE survey also provided insights into women's views of VVA treatments. Women reported displeasure with the vaginal administration route, lack of symptom relief with over-the-counter products, and concerns about the safety of estrogen therapies. With the high prevalence of VVA, obstetricians/gynecologists should become vigilant in identifying women with VVA by implementing screening and discussion of symptoms during routine office visits - providing patients with information about appropriate therapies based on the severity and impact of symptoms, keeping in mind individual preferences and perceptions.
- Employing laparoscopic surgery for endometriosis. [JOURNAL ARTICLE]
- Womens Health (Lond Engl) 2014 Jul; 10(4):431-443.
Endometriosis is a chronic, multifactorial disease, which can impact significantly on a women's quality of life. It is associated with pelvic pain, dyspareunia and intestinal disorders, and can lead to infertility. The use of laparoscopic surgery in the management of endometriosis is well documented; however, the optimal management of women with deep infiltrating disease remains controversial. This review describes the different surgical strategies for the treatment of endometriosis.