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European Journal of Obstetrics,... Aug 2016To prove the efficacy, tolerability and safety of Monurelle Biogel(®) (ZP-025) vaginal gel, which contains a purified, dialyzed, lyophilized bovine colostrum, in women... (Randomized Controlled Trial)
Randomized Controlled Trial
Efficacy, tolerability and safety of a new medical device, Monurelle Biogel(®) vaginal gel, in the treatment of vaginal dryness: a randomized clinical trial in women of reproductive age.
OBJECTIVE
To prove the efficacy, tolerability and safety of Monurelle Biogel(®) (ZP-025) vaginal gel, which contains a purified, dialyzed, lyophilized bovine colostrum, in women of reproductive age suffering from vaginal dryness.
DESIGN
Randomized clinical trial (RCT) (Z7213M01).
SETTING
Five University Gynaecological Units.
PATIENTS
Ninety-five subjects were allocated at random to receive either ZP-025 (n=48) for about 23 intermenstrual days (1 or 2 times/daily intra-vaginally) or no treatment (lubricants on demand were allowed).
MAIN OUTCOME MEASURES
Change of Verbal Rating Scale (VRS) total and single score for vaginal symptoms, Vaginal Health Index (VHI) score, Female Sexual Function index (FSFI) and Female Sexual Distress Scale-revised (FSDS-R) scores.
RESULTS
A total number of 85 subjects was evaluable for primary analyses. Symptoms (VRS) of vaginal discomfort improved significantly already after 11 days, as compared to the control arm (p<0.0001). The mean VHI score was also significantly higher in ZP-025 group (p<0.001) at the end of the study. The analysis of covariance with the baseline value as covariate carried out on the FSFI Total Score showed a statistically significant difference in favour of the ZP-025 arm (p<0.032). A shift from presence to absence of sexual distress (≤11 points) was more prominent in the ZP-025 arm [10 subjects (40%) in the ZP-025 arm (p<0.0001) and 6 subjects (21.4%) in the control arm (p=0.01)]. Women reported a compliance rate of 100% for one ZP-025 application/day. Local tolerability of ZP-025 was excellent or good in 82.9% of the subjects.
CONCLUSIONS
The present multicentre RCT supports the use of Monurelle Biogel(®) in women of reproductive age reporting symptoms of vaginal dryness. A positive impact on vaginal health and sexual function was also evident.
Topics: Administration, Intravaginal; Adult; Colostrum; Female; Humans; Libido; Middle Aged; Sexual Behavior; Treatment Outcome; Vaginal Creams, Foams, and Jellies; Vaginal Diseases; Young Adult
PubMed: 27261817
DOI: 10.1016/j.ejogrb.2016.05.005 -
Radiology and Oncology Sep 2023The term genitourinary syndrome of menopause was first used in 2014 by the North American Menopause Society and the International Society for the Study of Women's Sexual... (Review)
Review
BACKGROUND
The term genitourinary syndrome of menopause was first used in 2014 by the North American Menopause Society and the International Society for the Study of Women's Sexual Health to describe conditions previously known as atrophic vaginitis, urogenital atrophy, or vulvovaginal atrophy. It is a complex, chronic, progressive condition characterized by a wide range of signs and symptoms affecting sexual function and the tissues of the urinary and genital tracts. The main cause of genitourinary syndrome of menopause is estrogen deficiency caused by ovarian removal or dysfunction. The most bothersome symptoms are vaginal dryness, decreased vaginal lubrication, and pain during penetration and intercourse. They all have a negative impact on the quality of life.
CONCLUSIONS
The main goal of treatment is to relieve the symptoms. Treatment modalities are pharmacological or non-pharmacological. The first-line treatment for mild to moderate symptoms is the use of personal lubricants and moisturizers, but the gold standard is estrogen replacement therapy. Hormone therapy may not be an option for women with hormone-dependent cancer.
Topics: Female; Humans; Quality of Life; Vagina; Genital Neoplasms, Female; Vulva; Syndrome; Hormones; Atrophy
PubMed: 37494601
DOI: 10.2478/raon-2023-0038 -
Maturitas Nov 2005The involution of the female genital tract seems to reflect a built-in biological life expectancy, inter-related with the hypothalamic-hypophyseal-ovarian axis. Lower... (Review)
Review
The involution of the female genital tract seems to reflect a built-in biological life expectancy, inter-related with the hypothalamic-hypophyseal-ovarian axis. Lower levels of oestradiol have a number of adverse effects, including on the lower urinary tract. The major universal change is vaginal atrophy. The vaginal mucosa becomes thinner and dry, which can produce vaginal discomfort, dryness, burning, itching, and dyspareunia. The vaginal epithelium may become inflamed, contributing to urinary symptoms such as frequency, urgency, dysuria, incontinence, and/or recurrent infections. Moreover, it has been suggested that reduced oestrogen levels may affect periurethral tissues and contribute to pelvic laxity and stress incontinence. In association with hypoestrogenemia, changes in vaginal pH and vaginal flora may predispose post-menopausal women to urinary tract infection. Treatment to date has been based on local hormonal therapy, in the form of vaginal creams, tablets or suppositories. Other routes of hormone administration have also proved to be successful. Both local and systemic administration are both effective in maturation of the vaginal epithelium. However, despite the fact that the benefits of oestrogen replacement in preventing vaginal atrophy and reducing the incidence of related symptoms are well established, such therapy is contraindicated in some women and is not an acceptable option for others. Furthermore, the optimal HT administration route, the dosage regimen, and non-hormonal alternatives for improving symptoms and quality of life of the post-menopausal female population, have not been well studied. This review focuses on the changes involved in vaginal aging and efforts to present a synopsis of the pathophysiology and therapy of atrophic vaginitis and vaginal atrophy.
Topics: Aging; Atrophy; Estradiol; Estrogen Replacement Therapy; Female; Humans; Postmenopause; Vagina; Vaginitis
PubMed: 16139449
DOI: 10.1016/j.maturitas.2005.06.014 -
The Journal of Urology Feb 2006Depending on age it has been estimated that up to 40% of women have complaints of sexual problems, including decreased libido, vaginal dryness, pain with intercourse,... (Review)
Review
PURPOSE
Depending on age it has been estimated that up to 40% of women have complaints of sexual problems, including decreased libido, vaginal dryness, pain with intercourse, decreased genital sensation and difficulty or inability to achieve orgasm. In this review we address the etiologies and incidence, evaluation and treatment of female sexual dysfunction following vaginal surgery for indications such as stress urinary incontinence and pelvic organ prolapse; anterior/posterior colporrhaphy, perineoplasty and vaginal vault prolapse.
MATERIALS AND METHODS
Literature on the mechanisms by which vaginal surgery affects female sexual function are discussed along with related pathophysiology to potential causes. The anatomy, neurovascular supply of the clitoris and introitus, and intrapelvic nerve supply are discussed as related to vaginal surgery. Techniques to avoid neurovascular damage during pelvic floor surgery were corroborated by supporting literature. Literature regarding female sexual dysfunction following other procedures, such as vaginal hysterectomy, Martius flap interposition, and vesicovaginal and rectovaginal fistula repair were also discussed.
RESULTS
Current literature does not support an association between vaginal length following vaginal surgery and sexual function. The proportion of women who are sexually active does not appear to be affected by vaginal surgery. Sling surgery for urinary incontinence does not appear to adversely affect overall sexual function, although individual parameters of sexual function scores may vary, eg a significant percent of women report pain during intercourse. Some patients experience improved overall sexual function due to complete relief from coital incontinence
CONCLUSIONS
Symptomatic vaginal narrowing is rare even in women undergoing simultaneous posterior repair. Overall sexual satisfaction appears to be independent of therapy for urinary incontinence or prolapse. Data indicate that defect specific posterior colporrhaphy with the avoidance of levator ani plication may improve sexual function. The possible etiological factors for sexual dysfunction following vaginal surgery deserve further investigations.
Topics: Female; Genital Diseases, Female; Gynecologic Surgical Procedures; Humans; Sexual Dysfunction, Physiological; Vagina
PubMed: 16406967
DOI: 10.1016/S0022-5347(05)00168-0 -
Women's Health (London, England) Jul 2014Symptoms 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... (Review)
Review
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.
Topics: Adult; Aged; Atrophy; Communication; Dyspareunia; Female; Health Knowledge, Attitudes, Practice; Humans; Middle Aged; Perception; Postmenopause; Quality of Life; Sexual Behavior; Socioeconomic Factors; Vagina; Vulva; Women's Health
PubMed: 25259904
DOI: 10.2217/whe.14.29 -
Progres En Urologie : Journal de... Jul 2023Surgical introital reduction procedures are commonly performed for the treatment of vaginal laxity (VL), yet poorly studied. The aim of this study was to assess clinical...
OBJECTIVE
Surgical introital reduction procedures are commonly performed for the treatment of vaginal laxity (VL), yet poorly studied. The aim of this study was to assess clinical outcomes following surgical vaginal introital reduction for VL.
METHODS
This was an ambidirectional cohort study conducted in a single urogynecology center. All sexually active women who had vaginal introital surgical reduction for VL between March 2015 and September 2020 were included in this study. VL was defined as a genital hiatus distance ≥4cm according to the POP-Q classification, associated with symptoms of laxity. The primary endpoint was sexual health assessed by the Pelvi-Perineal Surgery Sexuality Questionnaire (PPSSQ), while the secondary endpoints included postoperative pain, perioperative complications, rate of dyspareunia, patient satisfaction and success rate based on the Patient Global Improvement Index (PGI-I) and Vaginal Laxity Questionnaire (VLQ).
RESULTS
Of the 27 patients sent the questionnaires, 23 sexually active patients returned the completed ones and were included in the study. Participants had a mean age and BMI of 41 years (range 24-74) and 21.3 (range 17.6-31.9) respectively. The most prevalent preoperative symptom was feeling of VL in 82.6% followed by bulging sensation in 47.8%. Preoperative dyspareunia was reported in 8/23 (34.8%). Surgical interventions involved perineorrhaphy with (n=14) or without (n=9) levator ani plication. The PPSSQ mean sexual health score was 86.7/100 (SD 5.8; range 16.7-93.3) and the mean discomfort and pain score was 27.5/100 (SD 26.0; range 0-80). Postoperative sexuality was reported to better, identical or worse in 16 (69.6%), 2 (8.7%) and 5 (21.7%) patients respectively. On PGI-I, patients reported feeling much better, better, slightly better and no change in 10 (43.5%), 5 (21.7%), 5 (21.7%) and 3 (13.0%) respectively. None of the women reported feeling worse. The overall post-operative complication rate was 3/23 (13.0%), including a perineal hematoma, and two cases of reoperation for narrow introitus. De novo dyspareunia was reported by 11/18 (61.1%) patients, occurring often or more in 4/18 (22.2%) patients, due to narrow introitus (n=2), enlarge introitus (n=1) and vaginal dryness (n=1).
CONCLUSION
Vaginal introital reduction surgery is a viable treatment option for symptoms of vaginal laxity after failure of conservative measures. However, patients should be made aware of the risk of de novo dyspareunia.
Topics: Humans; Female; Young Adult; Adult; Middle Aged; Aged; Dyspareunia; Cohort Studies; Vagina; Sexual Behavior; Pelvis
PubMed: 37263901
DOI: 10.1016/j.purol.2023.05.003 -
Maturitas Mar 2019To evaluate the efficacy of ospemifene in treating dyspareunia associated with postmenopausal vulvo-vaginal atrophy (VVA). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To evaluate the efficacy of ospemifene in treating dyspareunia associated with postmenopausal vulvo-vaginal atrophy (VVA).
METHODS
A structured search was carried out in PubMed-Medlin, Embase, Cochrane Controlled Trials Register databases through to 31 July 2018. The search included the following terms: "Ospemifene", "vulvovaginal atrophy", "dyspareunia", "SERM" and "randomized controlled trial" (RCTs). Four outcomes were selected: vaginal pH; proportions of parabasal and superficial vaginal cells; and perception of the most bothersome symptom (vaginal dryness or dyspareunia). A random-effects model was used in the meta-analysis. Study quality and bias risk were assessed with the Cochrane tool.
RESULTS
Six RCTs comparing the efficacy of ospemifene against placebo after 12 and 52 weeks of treatment were included in the meta-analysis. At 12 weeks, changes in vaginal Ph (SMD: -0.96, 95% CI:-1.12 to -0.81; p < 0.0001), parabasal cells (SMD: -36.84 95% CI -46.95 to -26.72; p < 0.0001), superficial cells (SMD: 8.23, 95% CI 3.73-12.74, p < 0.0003), and dyspareunia (SMD= - 2.70, 95% CI - 2.88 to -2.52, p < 0.0001) indicated that ospemifene was more effective than placebo.
CONCLUSION
The present meta-analysis suggests that ospemifene 60 mg is associated with significant improvement in the morphological and physiological features of the vaginal mucosa that correlate with the symptoms associated with postmenopausal VVA.
Topics: Atrophy; Female; Humans; Randomized Controlled Trials as Topic; Selective Estrogen Receptor Modulators; Tamoxifen; Treatment Outcome; Vagina; Vaginal Diseases; Vulva; Vulvar Diseases
PubMed: 30509753
DOI: 10.1016/j.maturitas.2018.11.016 -
Menopause (New York, N.Y.) Feb 2021Genitourinary syndrome of menopause (GSM) refers to a collection of symptoms resulting from diminished hormonal, primarily estrogenic stimulation to the vulvovaginal or... (Review)
Review
Genitourinary syndrome of menopause (GSM) refers to a collection of symptoms resulting from diminished hormonal, primarily estrogenic stimulation to the vulvovaginal or lower urinary tract and may affect up to 50% of postmenopausal women. Symptoms, which are typically progressive and unlikely to resolve spontaneously, may include, but are not limited to, vulvovaginal dryness, burning or irritation, dyspareunia, or urinary symptoms of urgency, dysuria or recurrent urinary tract infection. These symptoms are typically progressive and unlikely to resolve spontaneously. Diagnosis is clinical. Telemedicine may play a role in diagnosis, initiation of treatment, and follow-up of women with GSM. Effective treatments include moisturizers and lubricants, local hormonal therapy with estrogen or dehydroepiandrosterone, and oral selective estrogen receptor agonists. Laser or radiofrequency procedures, although currently utilized, are being studied to comprehensively understand their overall effectiveness and safety. Additionally, the influence and effect of the vaginal microbiome, as well as potential of treatment via its manipulation, is being studied. We performed a literature search of PubMed, Google Scholar, and Ovid with search terms of vulvovaginal atrophy and GSM and reviewed major US Society Guidelines to create this narrative review of this topic. The literature suggests that healthcare providers can make a significant impact of the health and quality of life of women by being proactive about discussing and providing interventions for GSM. A systematic approach with consideration of current guidelines and attention to developing protocols for interventions should be employed.
Topics: Atrophy; Dyspareunia; Female; Humans; Menopause; Quality of Life; Syndrome; Vagina
PubMed: 33534428
DOI: 10.1097/GME.0000000000001728 -
Seminars in Reproductive Medicine May 2005Reduction of ovarian steroids at menopause leads to significant changes in the urogenital tract. These changes often worsen with time, particularly in nonsmokers,... (Review)
Review
Reduction of ovarian steroids at menopause leads to significant changes in the urogenital tract. These changes often worsen with time, particularly in nonsmokers, affecting up to 38% of menopausal women. Urogenital symptoms that clearly respond to estrogen therapy include atrophic vaginitis, dryness, and accompanying dyspareunia. Estrogen reduces urinary tract infections in women plagued by frequent recurrence. The sensation of urgency improves with estrogen but urge incontinence improvement is similar to that with placebo. Stress incontinence does not improve with estrogen. Until recently, vaginal therapy was reserved for local symptoms. Rings make systemic vaginal therapy acceptable and even preferred by some users. Vaginal delivery, like other parenteral therapies, bypasses the gastrointestinal tract, with less anticipated impact on lipids, globulins, clotting, and fibrinolytic factors. Evidence of a lowered risk of venous thromboembolism is reviewed. Options for estrogen therapy include native, synthetic, or biologically derived estrogens delivered by cream, gel, insert (pessary), ring, or tablet. Even the lowest dose estradiol (7.5 mug daily or 25 mug twice per week) shows evidence of systemic absorption. In long-term placebo-controlled studies, bone density was better preserved and lipid profiles were more favorable. Therefore, even these low dose therapies should be opposed by occasional progestogen to prevent endometrial carcinoma. Intermittent therapy is best given for a minimum of 12 days based on laboratory data. Less frequent dosing, although preferred by patients, likely confers a slightly increased risk of hyperplasia. No combination estrogen/progestogen vaginal product is currently available. The best dose to reduce risk of endometrial pathology adequately in the lower dose therapies will be defined not only by the dose and potency of the exogenous estrogen but by the individual is body habitus and lifestyle choices.
Topics: Administration, Intravaginal; Estrogen Replacement Therapy; Female; Genital Diseases, Female; Genitalia, Female; Humans; Menopause; Urinary Incontinence; Urinary Tract; Urinary Tract Infections; Urologic Diseases; Vaginitis
PubMed: 15852198
DOI: 10.1055/s-2005-869480 -
Brachytherapy 2023Endometrial Cancer (EC) is the most common gynecologic malignancy in the United States. Standard treatment is TAH/BSO with radiation therapy (RT) and chemotherapy given...
PURPOSE
Endometrial Cancer (EC) is the most common gynecologic malignancy in the United States. Standard treatment is TAH/BSO with radiation therapy (RT) and chemotherapy given based on risk. Treatment can cause significant vaginal changes, including shortening, narrowing, loss of elasticity, atrophy, and dryness. These are not life threatening, but affect a woman's physical, psychological, and social functioning. Adjuvant vaginal dilator use is often advised, but there are inconsistent recommendations on use. This prospective study compared vaginal length changes and sexual function in women compliant with dilation versus not after surgery and RT.
METHODS AND MATERIALS
Enrolled patients underwent surgery for Stage I-IIIC EC ±RT. Vaginal dilator use was recommended for women receiving RT (external beam or brachytherapy). Vaginal length was measured with a vaginal sound and the Female Sexual Function Index (FSFI) was used to assess sexual function.
RESULTS
Forty-one enrolled patients had sufficient data for analysis. Dilation significantly increased FSFI scores (p = 0.02) while RT without dilation showed a significant decrease (p = 0.04). Dilation helped maintain vaginal length for all patients (0 cm vs. 1.8 cm loss (p = 0.03)). Individual arms did not show statistically significant changes in length with dilation, though the trend showed RT without dilation had an average loss of 2.3 cm as compared to only 0.2 cm for regular dilation. Notably, there was no difference in length change with dilation for surgery alone versus surgery and RT (p = 0.14).
CONCLUSION
This data provides novel, prospective evidence of the benefit of vaginal dilation for maintaining vaginal length and improving sexual health after any pelvic treatment for EC. This evidence also supports that the addition of RT after surgery does not appear to significantly worsen vaginal shortening. This study has important implications for providing a strong foundation for future studies and helping to establish solid clinical management criteria for the prevention of vaginal stenosis and promotion of female sexual health.
Topics: Female; Humans; Vagina; Brachytherapy; Prospective Studies; Constriction, Pathologic; Endometrial Neoplasms
PubMed: 36849277
DOI: 10.1016/j.brachy.2023.01.005