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1.
Menopause ; 31(9): 801-808, 2024 Sep 01.
Article in English | MEDLINE | ID: mdl-38954491

ABSTRACT

OBJECTIVE: To compare patient satisfaction rate in postmenopausal women who chose dynamic quadripolar radiofrequency or topical estrogens as their preferred treatment for genitourinary syndrome of menopause. METHODS: Patients were divided into two groups according to their preference: one was treated with estrogen therapy (ET) and the other with dynamic quadripolar radiofrequency treatment (RF). All patients included fulfilled a series of validated questionnaires, at baseline and at the 6-mo follow-up, in order to evaluate the discomfort degree associated with the presence of vulvovaginal atrophy and the impact of the reported symptoms on QoL and sexuality. RESULTS: After propensity score matching, the proportion of women considering themselves satisfied with their genital health conditions was extremely small at study entry (5.2% of the RF group and 6.9% of the ET group), while at a 6-mo follow-up, it increased to 46.7% and 46.6%, respectively. No statistically significant between-group differences were found regarding mean numerical rating scale scores for dryness and dyspareunia at follow-up (5.6 ± 2.6 vs 5.3 ± 2.3, P = 0.5; and 2.9 ± 2.5 vs 3.0 ± 2.7, P = 0.46). At 6-mo follow-up, we observed no statistically significant differences between the two groups regarding the other items evaluated. RF treatment was overall well tolerated. CONCLUSION: The use of quadripolar radiofrequency devices seems effective, but it is not associated with better clinical outcomes compared with topical hormone treatment, which is a substantially cheaper and more convenient treatment for genitourinary syndrome of menopause. Therefore, we suggest limiting the use of dynamic quadripolar radiofrequency selectively when topical estrogens are not effective, not tolerated, or contraindicated.


Subject(s)
Atrophy , Estrogens , Patient Preference , Postmenopause , Vagina , Vulva , Humans , Female , Middle Aged , Vulva/pathology , Vagina/pathology , Estrogens/administration & dosage , Estrogens/therapeutic use , Dyspareunia/drug therapy , Dyspareunia/therapy , Surveys and Questionnaires , Estrogen Replacement Therapy/methods , Patient Satisfaction , Quality of Life , Aged , Radiofrequency Therapy/methods , Treatment Outcome , Vaginal Diseases/drug therapy , Vaginal Diseases/therapy
2.
Arch Gynecol Obstet ; 310(2): 631-641, 2024 08.
Article in English | MEDLINE | ID: mdl-38898186

ABSTRACT

PURPOSE: Tumors affecting the female genital tract and their treatments have the potential to induce adverse modifications in vaginal health and impact personal aspects of patient's lives. Vulvovaginal atrophy is one of the morphological changes observed in individuals with a history of gynecological cancer, influenced both by the biological environment of tumors and the main therapeutic modalities employed. Therefore, the purpose of this study was to identify approaches to treat vulvovaginal atrophy while assessing the impact on the emotional and sexual health of women diagnosed with gynecological cancers. METHODS: To achieve this goal, a systematic review was conducted following the methodological guidelines outlined by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The databases used for literature research were PubMed and Web of Science. RESULTS: Initially, 886 articles were obtained. After eliminating duplicates and applying inclusion/exclusion criteria, seven articles were selected for analysis. The period of highest publication activity spanned from 2017 to 2020, with the majority conducted in Italy. Five treatment modalities were identified and categorized as vaginal suppository, oral medication, surgical procedure, CO2 laser therapy, and vaginal dilator. Twenty-four outcomes related to vaginal health and 30 outcomes related to overall, sexual, and emotional quality of life were analyzed. CONCLUSION: In general, all interventions demonstrated the ability to improve vaginal health or, at the very least, the sexual health of patients. Thus, despite limitations, all treatments have the potential to address vulvovaginal atrophy in patients with a history of gynecological cancer.


Subject(s)
Atrophy , Genital Neoplasms, Female , Quality of Life , Vagina , Vulva , Humans , Female , Genital Neoplasms, Female/therapy , Genital Neoplasms, Female/psychology , Genital Neoplasms, Female/pathology , Vagina/pathology , Vulva/pathology , Vaginal Diseases/therapy , Vaginal Diseases/pathology , Lasers, Gas/therapeutic use , Suppositories , Administration, Intravaginal
3.
Post Reprod Health ; 30(3): 147-155, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38842127

ABSTRACT

BACKGROUND: Genitourinary syndrome of menopause (GSM) is a common condition, yet there is no defined, objective, and reproducible intervention with which to make a diagnosis. There are many different treatment options available, but without the correct diagnosis, affected women are unable to access the right therapy. This paper reports on the questionnaire arm of the VAN study (VAginal Health - What's Normal?) which aimed to evaluate the performance and acceptability of the methods of assessment of GSM, described below. OBJECTIVES: To determine the value of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire: a multidimensional measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women, in a prospective, observational, feasibility study. METHODS: 60 women were recruited to the study (20 premenopausal, asymptomatic women (control group) and 40 peri- and postmenopausal, symptomatic women). All women had a baseline assessment, using three different interventions, in addition to the DIVA questionnaire and symptomatic women were offered treatment, followed by a second assessment undertaken at 16 weeks, using the same interventions. This paper focusses on the outcomes for the questionnaire and specifically on the paired data sets, before and after treatment. RESULTS: An improvement in the score for all four sections of DIVA (Activities of daily living, Emotions, Sexual Activity, and Feelings about yourself and your body (female embodiment)) was observed, following any treatment. Additional questions were added to DIVA, to assess patient preference in relation to the different diagnostic interventions. These included a speculum examination as part of the clinical assessment, a smear taken from the lateral vaginal wall to assess the vaginal maturation index, both undertaken by a clinician and a self-administered tampon to collect vaginal secretions, to determine the small molecule metabolite profile, using NMR spectroscopy, and to enable analysis of the vaginal microbiome. The medical standard tampon was the preferred intervention, before and after treatment, for women eligible for treatment. CONCLUSION: The VAN study demonstrates that DIVA, a previously tested questionnaire, is an easily accessible intervention, to assess the impact of urogenital symptoms on quality-of-life indicators in women in the United Kingdom with GSM and that women prefer to use a tampon themselves, rather than have a clinician performed vaginal speculum examination or a vaginal smear.


Subject(s)
Feasibility Studies , Menopause , Quality of Life , Vagina , Humans , Female , Middle Aged , Surveys and Questionnaires , Prospective Studies , Menopause/physiology , Menopause/psychology , Vagina/pathology , Syndrome , Female Urogenital Diseases/diagnosis , Female Urogenital Diseases/therapy , Female Urogenital Diseases/psychology , Adult , Vaginal Diseases/diagnosis , Vaginal Diseases/therapy , Vaginal Diseases/psychology , Aged
4.
Eur J Obstet Gynecol Reprod Biol ; 299: 342-344, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38811292

ABSTRACT

One in three women will experience pelvic floor disorders in her lifetime and nearly 60 percent of postmenopausal women are affected by vaginal dryness. Conservative management is recommended as first line treatment for pelvic organ prolapse and stress urinary incontinence. Also, vaginal estrogens are often prescribed for symptomatic vaginal atrophy. Lasers have been used in cosmetic industry for connective tissue remodeling and repair of skin. Their use in the last decade for treating genitourinary symptoms of menopause, pelvic organ prolapse and stress urinary incontinence has gained popularity but there is lack of robust evidence to support its use in routine practice. The European Board and College of Obstetrics and Gynaecology calls for high quality evidence with patient related outcome measures before adopting to routine clinical practice.


Subject(s)
Laser Therapy , Menopause , Pelvic Organ Prolapse , Urinary Incontinence, Stress , Vagina , Humans , Female , Urinary Incontinence, Stress/therapy , Pelvic Organ Prolapse/therapy , Vagina/surgery , Laser Therapy/methods , Gynecology , Vaginal Diseases/therapy , Europe
5.
Maturitas ; 185: 107978, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38583316

ABSTRACT

OBJECTIVES: The efficacy and tolerability of a non-hormonal pessary (that forms an oil-in-water emollient with the vaginal fluid) were assessed for the treatment of symptoms of vaginal dryness associated with menopause. STUDY DESIGN: Seventy-nine postmenopausal women (mean age 60.8 ± 6.5 years) with mild to moderate symptoms of vaginal dryness (including dyspareunia) were enrolled in this open-label, prospective, post-market clinical follow-up trial, conducted in 2022 by one research center in Germany. The investigational pessary was applied for the first 7 days once daily and the subsequent 31 days twice a week, at bedtime. A treatment-free period of 6 days completed the trial. MAIN OUTCOME MEASURES: During the trial, participants filled out questionnaires that enabled the calculation of a total severity score for subjective symptoms of atrophy-related vaginal dryness and impairment of daily as well as sexual life. Furthermore, vaginal health index and safety were studied. RESULTS: A rapid and significant reduction in the severity scores for symptoms was observed over the 38-day course of treatment and beyond. Quality of life assessed by DIVA (day-to-day impact of vaginal aging) questionnaire, dyspareunia and vaginal health index also clearly improved. The tolerability was mainly rated as "good to very good" by the investigator and 94.9 % of participants. The vast majority were very satisfied with the simple and pleasant handling. No serious adverse events occurred. CONCLUSION: Overall, the presented data suggest that the investigated non-hormonal pessary is an effective and well tolerated treatment option for vaginal symptoms associated with dryness, thus improving quality of life for women, even those who are sexually active. CLINICALTRIALS: gov identifier NCT05211505.


Subject(s)
Dyspareunia , Menopause , Pessaries , Quality of Life , Vagina , Vaginal Diseases , Humans , Female , Middle Aged , Vaginal Diseases/drug therapy , Vaginal Diseases/therapy , Aged , Prospective Studies , Dyspareunia/drug therapy , Dyspareunia/therapy , Dyspareunia/etiology , Vagina/drug effects , Vagina/pathology , Surveys and Questionnaires , Severity of Illness Index , Postmenopause , Treatment Outcome
6.
J Cosmet Dermatol ; 23(6): 2030-2043, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38450826

ABSTRACT

BACKGROUND: Vulvovaginal atrophy (VVA) includes a wide range of conditions affecting the reproductive and urinary systems, often requiring careful evaluation and management for optimal health. AIMS: This study aims to evaluate the symptom management effects of a real time temperature-monitored non-ablative RF device for the treatment of postmenopausal Chinese women with VVA symptoms. METHODS: This pilot study involved 24 postmenopausal Chinese women with one or more VVA symptoms, who wished to remain sexually active. VHIS, VAS, and FSFI were used to track and evaluate various aspects of the patient's condition. Analyses were conducted at the end of the study to verify the statistical significance of the treatment's results. RESULTS: All patients reported substantial, statistically significant, improvements on every VVA symptom tracked. Approximately 80% of the patients reported total symptom reversal at 12-week post-treatment follow-up. CONCLUSION: This pilot study demonstrated that non-ablative, monopolar RF technology equipped with real time temperature monitoring is feasible and safe in the treatment of postmenopausal women with VVA symptoms, and efficacious at up to 12 weeks post-treatment.


Subject(s)
Atrophy , Postmenopause , Vagina , Vulva , Humans , Female , Pilot Projects , Middle Aged , Vagina/pathology , Vulva/pathology , Vulva/radiation effects , China , Treatment Outcome , Aged , Vaginal Diseases/therapy , Vaginal Diseases/pathology , Radiofrequency Therapy/methods , Radiofrequency Therapy/adverse effects , Radiofrequency Therapy/instrumentation , Monitoring, Physiologic/methods , Monitoring, Physiologic/instrumentation , Asian People , East Asian People
7.
Climacteric ; 27(3): 236-244, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38318859

ABSTRACT

The issue of vaginal dryness in genitourinary syndrome of menopause (GSM) and its pervasive impact on women's quality of life is often overlooked. Extensive surveys conducted worldwide reveal limited understanding of vaginal dryness among public and health-care providers. Physician knowledge on menopause medicine varies globally, highlighting the need for standardized training. Effective communication between physicians and patients plays a crucial role in diagnosing and treating GSM symptoms. There are multiple treatment options to improve vaginal lubrication, including hormonal and non-hormonal therapies, along with lifestyle modifications. Tailoring treatments to individual patient preferences is crucial for compliance. Overall, GSM is multifaceted, from the prevalence of vaginal dryness to the nuances of treatment preferences. The urgency of widespread education and awareness of this matter must be underscored to meet the aim of enhancing the well-being and quality of life for women.


Subject(s)
Menopause , Quality of Life , Vaginal Diseases , Humans , Female , Menopause/physiology , Vaginal Diseases/therapy , Vagina , Estrogen Replacement Therapy
8.
Photodiagnosis Photodyn Ther ; 46: 104008, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38340885

ABSTRACT

BACKGROUND: Condyloma acuminatum (CA) of the vagina is a sexually transmitted disease due to infection by human papilloma virus (HPV). The treatment efficacy of the conventional methods for vaginal CA is often unsatisfactory with a high recurrence rate. Topical 5-aminolevulinic acid-mediated photodynamic therapy (ALA-PDT) combined with CO2 laser pretreatment is a feasible approach for vaginal CA, but the effectiveness and safety need further evaluation. METHODS: This study enrolled 15 patients with vaginal CA. All patients underwent CO2 laser ablation and then ALA-PDT for two or three cycles. The clinical efficacy and side effects were evaluated and analyzed during the treatment and 6 months after the treatment. RESULTS: The wart lesions in 4 cases (26.7 %) disappeared after the first treatment. The wart lesions in 5 cases (33.3 %) disappeared after the second treatment. And 6 cases (40 %) needed three treatment cycles before the lesions disappeared completely. The complete response (CR) rate was 93.3 % (14/15) at 2 weeks after three treatment cycles. There were 5 cases (83.3 %) which have complete remission after 2 treatments in warts diameter <1 cm group. There were only 4 cases (44.4 %) which have complete remission after 2 treatments in diameter>1 cm group. All patients had CR without reoccurrence at 6 months after treatment. The side effects mainly included a mild or moderate burning or stinging sensation (26.7 %). There were no infection, ulcers and scars after treatment. CONCLUSION: Topical 5-aminolevulinic acid-mediated photodynamic therapy combined with CO2 laser pretreatment is a safe and effective treatment for vaginal CA.


Subject(s)
Aminolevulinic Acid , Condylomata Acuminata , Lasers, Gas , Photochemotherapy , Photosensitizing Agents , Humans , Female , Aminolevulinic Acid/therapeutic use , Photochemotherapy/methods , Photosensitizing Agents/therapeutic use , Condylomata Acuminata/drug therapy , Condylomata Acuminata/therapy , Adult , Lasers, Gas/therapeutic use , Middle Aged , Vaginal Diseases/drug therapy , Vaginal Diseases/therapy , Young Adult , Combined Modality Therapy , Administration, Topical
9.
Climacteric ; 27(2): 210-214, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38251861

ABSTRACT

OBJECTIVE: A randomized controlled study was conducted to evaluate the safety and efficacy of radiofrequency treatment in postmenopausal women not willing to use or presenting a contraindication for menopause hormone therapy (MHT) and suffering from genitourinary syndrome of menopause (GSM). METHODS: A prospective randomized open study evaluated the effect of radiofrequency treatment versus a gel (control group) in postmenopausal women suffering from GSM. Patients were assessed at baseline and after 10-12 weeks of treatment for severity of vulvovaginal atrophy, dyspareunia, pH, vaginal smear maturation index, Vaginal Health Index and Female Sexual Function Index. The difference at baseline and after 10-12 weeks of treatment and the difference in improvement were tested between groups by a two-sample t-test and the Mann-Whitney test. RESULTS: Due to the COVID-19 pandemic, we were only able to treat 48 patients (24 patients using radiofrequency and 24 patients using a gel). Globally, at the end of the study, there were no differences in changes of the measured outcomes between the group of women treated with radiofrequency and the control group. CONCLUSION: Radiofrequency treatment was found to be safe, but was not superior to a gel, although the study lacked power. The study was registered at ClinicalTrials.gov (NCT03857893).


Subject(s)
Genital Diseases, Female , Vaginal Diseases , Female , Humans , Vaginal Diseases/therapy , Prospective Studies , Pandemics , Vagina/pathology , Menopause , Treatment Outcome , Atrophy
10.
Rev Assoc Med Bras (1992) ; 69(suppl 1): e2023S129, 2023.
Article in English | MEDLINE | ID: mdl-37556648

ABSTRACT

OBJECTIVE: This study aimed to analyze the evidence and controversies about the use of vaginal energy-based devices (laser and radiofrequency) for treatment of genitourinary syndrome of menopause, recurrent urinary tract infection, urinary incontinence, and genital prolapse through a literature review. METHODS: A search of literature databases (PubMed, Medline) was performed for publications in December 2022. Keywords included genitourinary syndrome of menopause, vaginal laxity, vaginal/vulvovaginal atrophy, urinary tract infection, urgency incontinence, frequency, urgency, stress urinary incontinence, genital prolapses AND energy-based devices, AND vaginal laser, AND vaginal radiofrequency, AND CO2 laser, AND Er:YAG laser. Publications in English from the last 7 years were reviewed and selected by the authors. RESULTS: The literature regarding vaginal energy-based devices in the treatment of urogynecological conditions is primarily limited to prospective case series with small numbers and short-term follow-up. Most of these studies showed favorable results, improvement of symptoms with low risk, or no mention of serious adverse events. Consensus statement documents from major medical societies suggest caution in recommending these therapies in clinical practice until more relevant data from well-designed studies become available. CONCLUSION: The potential of the vaginal laser and radiofrequency as a therapeutic arsenal for the evaluated urogynecological conditions is great, but qualified research must be done to prove their efficacy and long-term safety, define application protocols, and recommend the use of these technologies in clinical practice.


Subject(s)
Lasers, Solid-State , Urinary Incontinence, Stress , Vaginal Diseases , Female , Humans , Menopause , Vaginal Diseases/therapy , Vagina/surgery , Urinary Incontinence, Stress/surgery , Lasers, Solid-State/therapeutic use
11.
Climacteric ; 26(4): 353-360, 2023 08.
Article in English | MEDLINE | ID: mdl-37366082

ABSTRACT

It is estimated that the 25-50% of women who are reaching menopause every year report symptoms related to the genitourinary syndrome of menopause (GSM). The symptoms are not due simply to lack of estrogen. One possible contributing cause of symptoms is the vaginal microbiota. The vaginal microbiota is a dynamic entity and plays a critical role in the pathogenic interplay of postmenopausal changes. Treatment of this syndrome depends on the severity and type of the symptoms and on the preferences and expectations of women. As there are many treatment options, therapy should be individualized. While new evidence on the role of Lactobacilli in premenopause is emerging, the role of Lactobacilli is still unclear in GSM and the impact of microbiota on vaginal health remains conflictual. However, some reports show promising data on the effect of probiotic therapy in menopause. In the literature there are few studies and small population samples on the role of an exclusive therapy with Lactobacilli and further data will be mandatory. Studies involving large numbers of patients and different intervention periods will be necessary to obtain evidence of the preventive and curative role of vaginal probiotics.


Subject(s)
Genital Diseases, Female , Vaginal Diseases , Female , Humans , Menopause , Vagina/pathology , Vaginal Diseases/therapy , Premenopause , Perimenopause , Atrophy
12.
Climacteric ; 26(4): 361-366, 2023 08.
Article in English | MEDLINE | ID: mdl-37318030

ABSTRACT

Local estrogen therapy (LET) is the mainstay of treatment for vaginal dryness, dyspareunia and other urogenital symptoms because it may reverse some pathophysiological mechanisms associated with decreasing endocrine function and increasing aging. Over the years, several vaginal products including different formulations (tablets, rings, capsules, pessaries, creams, gels and ovules) and molecules (estradiol [E2], estriol [E3], promestriene, conjugated equine estrogens and estrone) have been used with superimposable therapeutic results. Low-dose and ultra-low-dose LET is the gold standard due to its minimal systemic absorption, with circulating E2 levels persistently remaining in the postmenopausal range. In healthy postmenopausal women, preference among the various products is presently the main driver and dissatisfaction with LET seems high, namely because of the delayed use in those with severe symptoms of genitourinary syndrome of menopause (GSM). Specific concerns remain in high-risk populations such as breast cancer survivors (BCS), especially those under treatment with aromatase inhibitors. Based on the multitude of symptoms under the umbrella of GSM definition, which includes vulvovaginal atrophy (VVA), it is mandatory to investigate specific effects of LET on quality of life, sexual function and genitourinary conditions by conducting studies with a patient-tailored focus.


Subject(s)
Dyspareunia , Vaginal Diseases , Humans , Female , Quality of Life , Estrogens/therapeutic use , Vaginal Diseases/therapy , Dyspareunia/drug therapy , Hormone Replacement Therapy , Vagina/pathology , Atrophy/drug therapy , Menopause
13.
BMC Womens Health ; 23(1): 282, 2023 05 24.
Article in English | MEDLINE | ID: mdl-37226145

ABSTRACT

BACKGROUND: This study aimed to explore the current situation and existing issues regarding the management of vulvovaginal atrophy (VVA) or the genitourinary syndrome of menopause (GSM). A nationwide web-based questionnaire survey was conducted among 1,031 Japanese women aged 40 years or older. MATERIALS AND METHODS: Eligible women were asked to complete a questionnaire about how they dealt with their symptoms and how satisfied they were with their coping methods. RESULTS: Of those highly conscious of their GSM symptoms (n = 208; 20.2%), 158 had sought medical consultation (15.3%), with only 15 currently continuing to seek consultation (11.5%). Of the specialties consulted, gynecology was the most frequently consulted (55%). Furthermore, those unwilling to seek medical consultation despite their symptoms accounted for the greatest proportion (n = 359; 34.8%), with 42 (23.9%) having never sought consultation. Topical agents, e.g., steroid hormone ointments/creams, were the most frequent treatments provided by the clinics (n = 71; 40.3%), followed by oral and vaginal estrogens (n = 27; 15.5%), suggesting that estrogen therapy was not the first choice of treatment at the clinics. While 65% of patients treated at the clinics reported satisfaction with the treatments, this was inconsistent with the fact that many were reported to have remained untreated and very few continued with treatment. CONCLUSIONS: Survey results suggest that GSM, including VVA, remains underdiagnosed and undertreated in Japan. Medical professionals should deepen their understanding of GSM and raise their level of care to select the appropriate treatment for the condition.


Subject(s)
Adaptation, Psychological , East Asian People , Female Urogenital Diseases , Menopause , Personal Satisfaction , Female , Humans , Atrophy , East Asian People/psychology , Menopause/physiology , Menopause/psychology , Atrophic Vaginitis/etiology , Atrophic Vaginitis/psychology , Vaginal Diseases/diagnosis , Vaginal Diseases/etiology , Vaginal Diseases/therapy , Female Urogenital Diseases/diagnosis , Female Urogenital Diseases/etiology , Female Urogenital Diseases/therapy
14.
Curr Opin Obstet Gynecol ; 35(2): 164-168, 2023 04 01.
Article in English | MEDLINE | ID: mdl-36924412

ABSTRACT

PURPOSE OF REVIEW: Menopause is a time of vulvar and vaginal changes that are physiologic and are often symptomatic. These changes can impact up to 50% of women in menopause. There are also several vulvar dermatoses that are more common after menopause and should be recognized early to allow for symptomatic treatment. Some of these conditions can lead to squamous cell carcinoma over time, and early recognition and appropriate treatment reduce this risk. Treatment for women with symptomatic vulvar and vaginal conditions is important for maintaining the quality of life. RECENT FINDINGS: There are multiple review articles, small case series, and small comparative trials, but definitive trials are unavailable for most of these conditions. SUMMARY: Current research on pathophysiology and treatment is limited to all of these conditions, and more focus on these life-altering conditions is warranted.


Subject(s)
Quality of Life , Vaginal Diseases , Female , Humans , Menopause , Vaginal Diseases/therapy , Vulva/pathology , Vagina/pathology
15.
Menopause ; 30(4): 383-392, 2023 04 01.
Article in English | MEDLINE | ID: mdl-36749915

ABSTRACT

To evaluate safety and effectiveness of therapeutic ultrasound for treatment of postmenopausal vaginal dryness. In a pilot study, postmenopausal women with self-reported vaginal dryness were randomized (1:1) to double-blind ultrasound treatment (n = 21) or sham (n = 21) for 12 weeks. Primary effectiveness endpoint was change from baseline to week 12 in Vaginal Assessment Scale symptoms (dryness, soreness, irritation, dyspareunia). Secondary effectiveness endpoint was scoring of clinician-reported Vaginal Health Index (elasticity, fluid, pH, mucosa, moisture). After 12 weeks, participants received open-label ultrasound treatment to 1 year. Safety endpoint was treatment-emergent adverse events. In the modified intent-to-treat population, women showed (mean ± standard error) reduction in Vaginal Assessment Scale with ultrasound treatment versus sham (n = 15, −0.5 ± 0.2 vs n = 15, −0.4 ± 0.3; P = 0.9) and improved Vaginal Health Index (n = 9, 2.7 ± 0.9 vs n = 9, 0.6 ± 1.4; P = 0.3). In the per-protocol analysis population, ultrasound treatment (n = 9) versus sham (n = 8) significantly reduced symptoms score (−0.6 ± 0.3 vs −0.0 ± 0.4; P = 0.05) and significantly improved Vaginal Health Index (2.7 ± 0.9 vs −0.4 ± 1.2; P = 0.03). Improvement in effectiveness endpoints were seen at 1 year compared with baseline. There were no differences in treatment-emergent adverse events between ultrasound treatment versus sham and no serious adverse events. Home-use ultrasound was safe and effective for treating vaginal dryness after 12 weeks. Effectiveness was maintained to 1 year. Therapeutic ultrasound could offer a new, nonhormonal treatment option for postmenopausal women with vulvovaginal atrophy.


Subject(s)
Dyspareunia , Ultrasonic Therapy , Vaginal Diseases , Female , Humans , Pilot Projects , Postmenopause , Vaginal Diseases/therapy , Vaginal Diseases/drug therapy , Vagina/diagnostic imaging , Vagina/pathology , Atrophy/pathology , Treatment Outcome , Dyspareunia/drug therapy , Vulva/pathology , Administration, Intravaginal
16.
Climacteric ; 26(2): 129-134, 2023 04.
Article in English | MEDLINE | ID: mdl-36697389

ABSTRACT

OBJECTIVES: This study aimed to evaluate the efficacy of vaginal oxygen and hyaluronic acid on genito-urinary symptoms of breast cancer survivors. METHODS: Patients were enrolled at the Menopause Outpatient Clinic of a university hospital. Breast cancer patients in a stable relationship, suffering from vaginal atrophy (VA) consequent to hypoestrogenism, were included. Natural oxygen was introduced into the vagina for 15 min, coupled in the last 5 min with a 2% solution of hyaluronic acid. Treatment was repeated five times, every 15 days. RESULTS: Out of the 40 breast cancer patients enrolled, 65% had no sexual intercourse due to pain. During treatment, the Vaginal Health Index Score gradually improved from 9.5 ± 2.2 to 16.8 ± 2.8 (p < 0.001), the visual analog scale score for dyspareunia decreased from 8.9 ± 1.3 to 3.4 ± 2.1 (p < 0.001) and the Female Sexual Function Index increased from 8.6 ± 6.3 to 15.2 ± 8.1 (p < 0.001). At the end of treatment, only 15% women (p = 0.001 vs. pretreatment) had no intercourse due to pain. Benefits remained 30 days after last treatment. CONCLUSION: Vaginal oxygenation coupled with hyaluronic acid every 15 days improves VA, sexuality and urinary symptoms of breast cancer patients. Beside data confirmation, additional studies are needed to determine the best interval between treatments, the optimal length of treatment and the long-term duration of the benefits.


Subject(s)
Breast Neoplasms , Cancer Survivors , Dyspareunia , Vaginal Diseases , Female , Humans , Male , Hyaluronic Acid/therapeutic use , Breast Neoplasms/therapy , Breast Neoplasms/pathology , Oxygen , Vagina/pathology , Vaginal Diseases/therapy , Dyspareunia/drug therapy , Dyspareunia/etiology , Pain/pathology , Atrophy , Treatment Outcome
17.
Minerva Obstet Gynecol ; 75(2): 138-144, 2023 Apr.
Article in English | MEDLINE | ID: mdl-34498835

ABSTRACT

BACKGROUND: The aim of this study was to evaluate the efficacy of ospemifene in the Vaginal Health Index (VHI), in the vulvovaginal vascular perfusion, and to assess its impact on quality of life and sexual function. METHODS: Among 52 eligible patients, 43 consecutive postmenopausal patients affected by vulvo-vaginal atrophy (VVA), or genitourinary syndrome (GSM) were evaluated. VVA evaluation and ultrasound of the vulvo-vaginal vascularization by sampling the Pulsatility Index (PI) of clitoris dorsal artery were performed before and after 3 months-treatment with ospemifene. The 36-Item Short Form Survey (SF-36) for the quality-of-life assessment before and after 3 months were available for all women; instead, Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS) questionnaires for the sexual function evaluation were performed for sexually active women in the study. The Patient Impression of Global Improvement (PGI-I) after 3 months of treatment was also calculated. RESULTS: The number of sexually active women significantly increased after 3 months (26 [60.46%] vs. 35 [81.39%]; P=0.01). The mean number of intercourses during the treatment increased (12.87±3.43 vs. 15.79±3.12, P=0.03). The PI of clitoris dorsal artery has significantly changed before and after treatment respectively (PI [1.69±0.42 vs. 1.28±0.45, P=0.001] RI [0.74±0.11 vs. 0.54±0.15, P=0.001]). The FSFI, FSDS and SF-36 Questionnaires scores showed a significant improvement after 3 months. VHI and PI were the independent factors of a lower FSFI after 3 months of treatment at multivariate analysis. CONCLUSIONS: Ospemifene improve the VHI and vulvovaginal vascular perfusion demonstrating a positive impact on sexual function and quality of life.


Subject(s)
Clitoris , Vaginal Diseases , Female , Humans , Postmenopause , Quality of Life , Tamoxifen , Vaginal Diseases/therapy
18.
Medicina (Kaunas) ; 58(6)2022 Jun 06.
Article in English | MEDLINE | ID: mdl-35744033

ABSTRACT

Vulvovaginal atrophy (VVA) is a chronic progressive disease involving the female genital apparatus and lower urinary tract. This condition is related to hypoestrogenism consequent to menopause onset but is also due to the hormonal decrease after adjuvant therapy for patients affected by breast cancer. Considering the high prevalence of VVA and the expected growth of this condition due to the increase in the average age of the female population, it is easy to understand its significant social impact. VVA causes uncomfortable disorders, such as vaginal dryness, itching, burning, and dyspareunia, and requires constant treatment, on cessation of which symptoms tend to reappear. The currently available therapies include vaginal lubricants and moisturizers, vaginal estrogens and dehydroepiandrosterone (DHEA), systemic hormone therapy, and Ospemifene. Considering, however, that such therapies have some problems that include contraindications, ineffectiveness, and low compliance, finding an innovative, effective, and safe treatment is crucial. The present data suggest great efficacy and safety of a vaginal laser in the treatment of genital symptoms and improvement in sexual function in patients affected by VVA. The beneficial effect tends to be sustained over the long-term, and no serious adverse events have been identified. The aim of this review is to report up-to-date efficacy and safety data of laser energy devices, in particular the microablative fractional carbon dioxide laser and the non-ablative photothermal Erbium-YAG laser.


Subject(s)
Lasers, Gas , Vaginal Diseases , Atrophy/therapy , Female , Humans , Menopause , Treatment Outcome , Vagina/pathology , Vaginal Diseases/therapy
19.
J Obstet Gynaecol ; 42(7): 3397-3399, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35658728

ABSTRACT

This brief report evaluates the early effect of ultra-low dose 0.005% oestriol vaginal gel on dyspareunia in postmenopausal women within the first 2 weeks of treatment. This was a prospective and multicentre single-arm pilot study and the effect of the treatment on dyspareunia was evaluated by using a diary. In total 23 women and 150 coitus were studied. 8 coitus were painless in the first week and 42 during the second week (p < .0001). A reduction in pain from the baseline was seen in 116 (77.3%) out of the 150 coitus. 0.005% oestriol vaginal gel produced a rapid and progressive improvement in dyspareunia from the very first days of treatment in postmenopausal women.IMPACT STATEMENTWhat is already known on this subject? Local oestrogen therapy has shown efficacy in the treatment of genitourinary syndrome of menopause (GSM) and dyspareunia when used for a duration of greater than 3 weeks.What do the results of this study add? This study shows that the use of oestriol gel produces clinical effects from the beginning of its use, decreasing dyspareunia in postmenopausal women within just 14 days of daily use.What are the implications of these findings for clinical practice and/or further research? In cases of dyspareunia in relation to menopause, therapy with local oestrogens, in our case oestriol gel, produces an improvement from the beginning of its use. This information is clinically relevant when evaluating therapeutic options.


Subject(s)
Dyspareunia , Vaginal Diseases , Female , Humans , Dyspareunia/drug therapy , Dyspareunia/etiology , Postmenopause , Pilot Projects , Vaginal Diseases/therapy , Vagina , Prospective Studies , Vaginal Creams, Foams, and Jellies , Estriol
20.
Int J Gynaecol Obstet ; 157(3): 536-543, 2022 Jun.
Article in English | MEDLINE | ID: mdl-34463351

ABSTRACT

OBJECTIVE: To evaluate the efficacy of the injection of microfragmented adipose tissue in the treatment of women with genitourinary syndrome of menopause (GSM). METHODS: This observational cohort study included 12 women who received one session of multiple injections of microfragmented adipose tissue using the SEFFIGYN™ medical device. Symptoms such as burning, itching, dryness, pain on penetration, pain during deep intercourse, and pain on urination were assessed before the patient's treatment (T0), after 15 days (T15), and after 5 months (5Mo) using the Numerical Rating Scale (NRS). RESULTS: An improvement of vulvar trophism was clinically evident already 2 weeks after treatment; all symptoms were notably attenuated compared with the initial visit, as demonstrated by statistically significant reductions of the NRS scores (P = 0.003 for itching, P = 0.008 for pain on urination, and P < 0.001 for the other symptoms, Sign test). Moreover, all symptoms continued to improve over time. All patients reported a positive change in their quality of life and a resumption of sexual life. CONCLUSION: The use of microfragmented adipose tissue in GSM is promising. Nevertheless, more studies will be fundamental to exclude a potential placebo effect and better understand the underlying molecular mechanism of action.


Subject(s)
Gynecology , Vaginal Diseases , Female , Humans , Menopause , Pain , Pruritus , Quality of Life , Regenerative Medicine , Vagina , Vaginal Diseases/therapy
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