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Vaginal atrophy

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https://www.readbyqxmd.com/read/28722159/commentary-changes-are-still-needed-on-multiple-co-primary-endpoints
#1
Christy Chuang-Stein, Jianjun David Li
The Food and Drug Administration in the United States issued a much-awaited draft guidance on 'Multiple Endpoints in Clinical Trials' in January 2017. The draft guidance is well written and contains consistent message on the technical implementation of the principles laid out in the guidance. In this commentary, we raise a question on applying the principles to studies designed from a safety perspective. We then direct our attention to issues related to multiple co-primary endpoints. In a paper published in the Drug Information Journal in 2007, Offen et al...
July 19, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28690873/spinal-cord-infarction-in-a-sick-neonate-from-predominant-haemorrhagic-aetiology-a-case-report
#2
Richa Kulshrestha, Joy R Chowdhury, Radhesh K Lalam, Nigel T Kiely
INTRODUCTION: Spinal cord injuries in new born infants following a traumatic delivery or umbilical cord catheterisation due to thromboembolism are well known. Cases with atraumatic acute onset of neonatal paraplegia have also been described in preterm babies or babies born small for gestational age with a stormy postnatal course related to ischaemic aetiology. We describe a rare case of infarction of the spinal cord from a predominant haemorrhagic aetiology. CASE PRESENTATION: A term female baby, first child of unrelated parents, was born by normal vaginal delivery...
2017: Spinal Cord Series and Cases
https://www.readbyqxmd.com/read/28680606/management-of-fetal-death-complicated-by-placenta-previa-during-the-midtrimester
#3
Sayuri Nakanishi, Ryosuke Shindo, Shigeru Aoki
Expectant management of fetal death complicated by placenta previa occurring during midtrimester trimester may induce fetal/placental atrophy and decrease uterine blood flow to facilitate vaginal delivery. Our experience with these cases suggests that about 4 weeks of expectant management should be considered as a management strategy.
July 2017: Clinical Case Reports
https://www.readbyqxmd.com/read/28680463/diagnosis-and-treatment-of-herpes-simplex-1-virus-infection-in-pregnancy
#4
REVIEW
Rachel Lee, Manju Nair
A nulliparous woman presented at 21 weeks' gestation with a 72-h history of a rash on her left arm. Initially isolated to the forearm, it had quickly spread, becoming multiple itchy fluid-filled blisters. Blood tests showed mild neutrophilia and raised CRP. Skin swabs demonstrated the presence of herpes simplex virus type 1 (HSV1) DNA. There was no history of previous HSV1 exposure. There is scant literature on uncomplicated cutaneous HSV1 since the majority is oral/genital. The incidence of transmission varies and is dependent on site of infection and immunological status...
June 2017: Obstetric Medicine
https://www.readbyqxmd.com/read/28679021/population-pharmacokinetic-analysis-of-vaginally-and-intravenously-administered-oxytocin-in-postmenopausal-women
#5
Elisabet I Nielsen, Shahla H Al-Saqi, Aino F Jonasson, Kerstin Uvnäs-Moberg
Oxytocin is a neuropeptide hormone used clinically for more than 50 years due to its ability to induce uterine contractions and milk ejection. Vagitocin is a vaginal oxytocin gel developed as a potential treatment of vaginal atrophy in postmenopausal women. The aim of this study was to characterize the oxytocin pharmacokinetics following vaginal and intravenous administration in postmenopausal women. Data from 33 participants enrolled in 2 clinical studies were used in the analysis, with a total of 651 observed oxytocin plasma concentrations, of which 78 were baseline observations, 178 observations following intravenous administration (10 IU), and 395 observations following vaginal administration (100 or 400 IU)...
July 5, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28657769/monurelle-biogel-%C3%A2-vaginal-gel-in-the-treatment-of-vaginal-dryness-in-postmenopausal-women
#6
R E Nappi, A Cagnacci, A M Becorpi, C Nappi, A M Paoletti, M Busacca, S Martella, M Bellafronte, Z Tredici, C Di Carlo, V Corda, M Vignali, M Bagolan, M Sardina
OBJECTIVES: To evaluate efficacy, tolerability and safety of Monurelle Biogel(®) vaginal gel for treatment of vaginal dryness. METHODS: Multicenter, national, randomized, controlled vs. no-treatment, open-label study. Ninety-five postmenopausal women were randomized (48 to Monurelle Biogel(®) and 47 to no treatment). Primary endpoint was the change of Verbal Rating Scale (VRS) total score of vaginal atrophy (VA) symptoms after 8-week treatment. The main secondary endpoints were VRS single-item score, Vaginal Health Index (VHI) score, Maturation Index (MI), Female Sexual Function Index (FSFI), and Female Sexual Distress Scale-Revised (FSDS-R)...
June 28, 2017: Climacteric: the Journal of the International Menopause Society
https://www.readbyqxmd.com/read/28655486/vaginal-atrophy-in-breast-cancer-survivors-attitude-and-approaches-among-oncologists
#7
Nicoletta Biglia, Valentina Elisabetta Bounous, Marta D'Alonzo, Laura Ottino, Valentina Tuninetti, Elisabetta Robba, Tania Perrone
BACKGROUND: Vulvovaginal atrophy (VVA) is a relevant problem for breast cancer survivors (BCSs), in particular for those who receive aromatase inhibitors (AIs). We conducted a survey, to assess the attitude of oncologists toward the diagnosis and treatment of VVA in BCSs. MATERIALS AND METHODS: In 2015, 120 computer-assisted Web interviews were performed among breast oncologists. RESULTS: According to oncologists' perceptions, 60% of postmenopausal BCSs and 39...
May 19, 2017: Clinical Breast Cancer
https://www.readbyqxmd.com/read/28640166/missing-documentation-in-breast-cancer-survivors-genitourinary-syndrome-of-menopause
#8
Elise D Cook, Elena I Iglehart, George Baum, Leslie L Schover, Lonzetta L Newman
OBJECTIVE: Breast cancer survivors often take hormonal treatments to prevent the recurrence of breast cancer, particularly aromatase inhibitors that can worsen the symptoms of genitourinary syndrome of menopause (GSM) such as dyspareunia, dysuria, and urinary incontinence, all of which may adversely affect survivors' quality of life. Few breast cancer survivors experiencing GSM receive adequate assessment or treatment. METHODS: In this descriptive study, we reviewed medical records for documented GSM and any treatments administered or referrals for treatment in 800 female patients who visited the Breast Cancer Survivorship Clinic at a comprehensive cancer center between July 1, 2010 and June 30, 2011, either at least 5 years after completion of treatment for invasive breast cancer or at least 6 months after completion of treatment for ductal carcinoma in situ...
June 19, 2017: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/28640161/combined-data-of-intravaginal-prasterone-against-vulvovaginal-atrophy-of-menopause
#9
Fernand Labrie, David F Archer, Céline Martel, Mario Vaillancourt, Marlene Montesino
OBJECTIVE: To analyze the effects of intravaginal prasterone obtained in the three randomized clinical studies performed in postmenopausal women suffering from moderate to severe (MS) dyspareunia due to vulvovaginal atrophy (VVA). METHODS: In three independent 12-week prospective, randomized, double-blind, and placebo-controlled clinical studies, the effect of daily intravaginal 0.50% (6.5 mg) prasterone was examined on four co-primary objectives in women having MS pain during sexual activity (dyspareunia), identified as their most bothersome symptom (MBS) of VVA at baseline...
June 19, 2017: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/28640158/vasomotor-symptoms-are-associated-with-depressive-symptoms-in-community-dwelling-older-women
#10
Berihun M Zeleke, Robin J Bell, Baki Billah, Susan R Davis
OBJECTIVE: To assess the prevalence of, and factors associated with, moderate-to-severe depressive symptoms in community-dwelling older Australian women. METHODS: A questionnaire-based, cross-sectional study was conducted amongst community-dwelling older women. Participants were recruited between April and August 2014 from a national database based on the electoral roll. Depressive symptoms were assessed by the Beck Depression Inventory-II (BDI-II) tool. Vasomotor symptoms (VMS), vulvovaginal atrophy (VVA), and pelvic floor symptoms were assessed using validated questionnaires...
June 19, 2017: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/28635978/vaginal-testosterone-for-management-of-aromatase-inhibitor-related-sexual-dysfunction-an-integrative-review
#11
Emily A Lemke, Lydia T Madsen, Joyce E Dains
PROBLEM IDENTIFICATION: Women taking aromatase inhibitors (AIs) as part of the management of hormone receptor-positive breast cancer experience more symptoms of sexual dysfunction, including vaginal atrophy, as opposed to postmenopausal women and women treated with tamoxifen (Nolvadex®). Vaginal testosterone could be an alternative to estrogen, which is contraindicated in this population.
. LITERATURE SEARCH: A systematic review was completed by searching PubMed and Scopus databases...
May 1, 2017: Oncology Nursing Forum
https://www.readbyqxmd.com/read/28622049/the-efficacy-and-safety-of-estriol-to-treat-vulvovaginal-atrophy-in-postmenopausal-women-a-systematic-literature-review
#12
C Rueda, A M Osorio, A C Avellaneda, C E Pinzón, O I Restrepo
OBJECTIVES: To evaluate the efficacy and safety of estriol for the treatment of vulvovaginal atrophy in postmenopausal women. METHODS: A systematic literature review was performed. We searched the following electronic databases: Medline, Cochrane, Embase, Lilacs, CINHAL and Google Scholar. The studies selected included controlled clinical trials and quasi-experimental studies. Selections were made in pairs and independently, first by title and abstract and then complete texts...
August 2017: Climacteric: the Journal of the International Menopause Society
https://www.readbyqxmd.com/read/28610687/assessing-the-thickness-of-the-vaginal-wall-and-vaginal-mucosa-in-pre-menopausal-versus-post-menopausal-women-by-transabdominal-ultrasound-a-feasibility-study
#13
Adrian Balica, Daniella Wald-Spielman, Katherine Schertz, Susan Egan, Gloria Bachmann
OBJECTIVE: As life expectancy increases, the number of women reporting adverse genito-urinary symptoms (genitourinary syndrome of menopause; GSM) from menopause, including vaginal dryness and sexual pain, also will increase. Current objective measurements of vaginal atrophy such as maturation index require vaginal swabs and are invasive; at present, no minimally invasive measurements exist. The purpose of this study was to assess whether total vaginal wall thickness (TVT) and total vaginal mucosa thickness (TMT) as measured by transabdominal ultrasound could qualify as additional objective markers of vaginal wall thinning which could be related to menopausal status...
August 2017: Maturitas
https://www.readbyqxmd.com/read/28608667/dynamic-quadripolar-radiofrequency-treatment-of-vaginal-laxity-menopausal-vulvo-vaginal-atrophy-12-month-efficacy-and-safety
#14
Franco Vicariotto, Francesco DE Seta, Valentina Faoro, Mauro Raichi
BACKGROUND: Twelve-month extension of a previous spontaneous exploratory study investigating safety and efficacy of a new low-energy dynamic quadripolar radiofrequency (DQRF) device in: A) premenopausal women with symptoms of vaginal laxity, with special reference to dysuria, urinary incontinence and unsatisfactory sexual life (vaginal laxity arm of the study); B) postmenopausal women with vulvovaginal atrophy/genitourinary syndrome of menopause (VVA/GSM) and VVA/GSM-related symptoms (VVA/GSM arm of the study)...
August 2017: Minerva Ginecologica
https://www.readbyqxmd.com/read/28562130/effects-of-ospemifene-on-vaginal-epithelium-of-post-menopausal-women
#15
Stefania Alvisi, Maurizio Baldassarre, Valentina Martelli, Giulia Gava, Renato Seracchioli, Maria Cristina Meriggiola
Ospemifene is a selective estrogen receptor modulator used for the treatment of vulvo-vaginal atrophy (VVA) in post-menopausal women. No direct evidence of its effects on histological features of the human vagina has been reported. To evaluate the effects of ospemifene on histological parameters, glycogen content, proliferation, and estrogen receptor α expression (ERα) of vaginal epithelium in post-menopausal women. Thirty-two post-menopausal women undergoing surgical procedures were enrolled. Sixteen subjects taking ospemifene at the time of inclusion (OSP) were compared to 16 subjects not taking any hormone (CTL)...
May 31, 2017: Gynecological Endocrinology
https://www.readbyqxmd.com/read/28539177/relationship-between-changes-in-vulvar-vaginal-atrophy-and-changes-in-sexual-functioning
#16
JoAnn V Pinkerton, Andrew G Bushmakin, Barry S Komm, Lucy Abraham
OBJECTIVE: Conjugated estrogens/bazedoxifene (CE/BZA) has demonstrated benefit in vulvar-vaginal atrophy (VVA, part of genitourinary syndrome of menopause) and the sexual function domain of the Menopause-specific Quality of Life (MENQOL) questionnaire. The study's objective was to determine the relationship of VVA symptoms and clinical parameters with MENQOL sexual functioning in postmenopausal women receiving VVA treatment. STUDY DESIGN: Post hoc analysis data were derived from the 12-week SMART-3 trial, which evaluated CE/BZA's effect on VVA in nonhysterectomized postmenopausal women (aged 40-65 years) experiencing one or more moderate to severe VVA symptoms (dryness, itching/irritation, pain with intercourse) and vaginal pH>5...
June 2017: Maturitas
https://www.readbyqxmd.com/read/28523261/rejuvenation-using-platelet-rich-plasma-and-lipofilling-for-vaginal-atrophy-and-lichen-sclerosus
#17
Seok Hwan Kim, Eun Soo Park, Tae Hee Kim
Vaginal atrophy is a common condition among peri- and post-menopausal women. Symptoms of vaginal dryness, pruritus, irritation, loss of subcutaneous fat, sparse pubic hair and dyspareunia occur due to decreased estrogen level. Estrogen-based treatments are effective. But many patients are reluctant to be treated due to health concerns. As alternatives, we explored the efficacy of platelet-rich plasma (PRP) and lipofilling. A 67-year-old female patient with vaginal atrophy was referred to our department. Treatment using estrogen cream had failed to improve patient's symptoms...
April 2017: Journal of Menopausal Medicine
https://www.readbyqxmd.com/read/28503946/fractional-co2-laser-therapy-a-new-challenge-for-vulvovaginal-atrophy-in-postmenopausal-women
#18
G P Siliquini, V Tuninetti, V E Bounous, F Bert, N Biglia
OBJECTIVE: To evaluate the effects of CO2 laser in the treatment of vulvovaginal atrophy (VVA) in postmenopausal women. METHODS: VVA was assessed in 87 postmenopausal women (mean age 58.6 ± 6.9 years) before and after the treatment. The protocol consisted of three monthly treatments and included the treatment of vulva. Subjective measures included VAS (Visual Analog Scale) both for vaginal dryness and dyspareunia; DIVA (Day-by-day Impact of Vaginal Aging); a questionnaire on treatment satisfaction and one about the degree of pain during the procedure...
May 15, 2017: Climacteric: the Journal of the International Menopause Society
https://www.readbyqxmd.com/read/28492016/vaginal-rejuvenation-using-energy-based-devices
#19
REVIEW
Cheryl Karcher, Neil Sadick
Physiologic changes in a woman's life, such as childbirth, weight fluctuations, and hormonal changes due to aging and menopause, may alter the laxity of the vaginal canal, damage the pelvic floor, and devitalize the mucosal tone of the vaginal wall. These events often lead to the development of genitourinary conditions such as stress urinary incontinence; vaginal atrophy; dryness; and physiologic distress affecting a woman's quality of life, self-confidence, and sexuality. Various treatment modalities are currently available to manage these indications, varying from invasive vaginal surgery to more benign treatments like topical vaginal hormonal gels or hormone-replacement therapy...
September 2016: International Journal of Women's Dermatology
https://www.readbyqxmd.com/read/28490209/retrospective-analysis-in-46-women-with-vulvovaginal-atrophy-treated-with-ospemifene-for-12-weeks-improvement-in-overactive-bladder-symptoms
#20
Michele Carlo Schiavi, Marzio Angelo Zullo, Pierangelo Faiano, Ottavia D'Oria, Giovanni Prata, Vanessa Colagiovanni, Andrea Giannini, Chiara Di Tucci, Giorgia Perniola, Violante Di Donato, Marco Monti, Ludovico Muzii, Pierluigi Benedetti Panici
AIMS: The aim of this study was to assess the effectiveness and safety of ospemifene in the improvement of overactive bladder (OAB) symptoms in postmenopausal women affected by vulvovaginal atrophy (VVA). METHODS: Forty-six postmenopausal patients affected by VVA with OAB syndrome were enrolled for the study. All patients received Ospemifene 60 mg for 12 weeks. Clinical examination, 3-day voiding diary, urodynamic testing, ultrasound measurement of endometrial and bladder wall thickness (BWT) and the Vaginal Health Index (VHI) were performed at baseline and 12 weeks...
May 11, 2017: Gynecological Endocrinology
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