Genitourinary syndrome of menopause (GSM) is defined as a collection of signs and symptoms that are mainly associated with the decrease in estrogen production during menopause.1 It involves changes in the labia, clitoris, introitus, vagina, urethra, and bladder. Approximately 50% of menopausal and postmenopausal women develop signs and symptoms of GSM.2-4 Symptoms of GSM include vaginal dryness; irritation/burning/itching of the vulva or vagina; diminished lubrication, dyspareunia, or discomfort with sexual activity; postcoital bleeding; reduced arousal, orgasm, and desire; dysuria; and urinary frequency and urgency.5,6 Vaginal dryness is one of the most prevalent symptoms, affecting up to 60% of postmenopausal women.7,8 GSM is also characterized by the following signs: decreased moisture, decreased elasticity, labia minora resorption, pallor/erythema, loss of vaginal rugae, tissue fragility/fissures/petechiae, urethral eversion or prolapse, loss of hymenal remnants, prominence of urethral meatus, introital retraction, and recurrent urinary tract infections.1 Decreased moisture is the most prevalent sign.1 The symptoms of GSM are bothersome and usually require intervention.9,10 They cause discomfort and distress in middle-aged and older women, impacting their quality of life (QoL), sexual functioning, and daily living activities.11-15 Despite the valuable information about the prevalence of GSM and its impact on sexual activity, little is known about its impact on multiple dimensions of well-being or functioning in the daily lives of postmenopausal women. The GENISSE study was a multicenter, cross-sectional, descriptive, observational study that involved 430 postmenopausal women who consulted a gynecologist in Spain for any reason between September and October 2015.16 It found the prevalence of GSM to be approximately 70%. In that study, the diagnosis of GSM was based on the presence of at least 2 symptoms, or 1 sign and 1 symptom (bothersome to the woman), and not otherwise explained by any other pathology.1,16 At the time of diagnosis, only 40% of women reported a prior history of vulvovaginal atrophy (VVA) or GSM. Furthermore, GSM was undetected in 60% of cases, as diagnosed when visiting the gynecologist for a routine visit (with no previous gynecological pathology). Given the importance of well-being and functioning in postmenopausal women, one of the objectives of the GENISSE study was to evaluate the impact of signs and symptoms of GSM on the QoL.17
The GENISSE study was a multicenter, cross-sectional, descriptive, observational study of GSM in a cohort of Spanish postmenopausal women. Consecutive women visiting the gynecologist's office for any reason were asked to participate in the study. The inclusion criteria were: between 30 and 75 years of age; absence of menstrual period for at least 1 year (at the time of the visit to the gynecologist); and no difficulty comprehending, reading, writing, and to have signed a written informed consent form. Women participating in any other clinical study, or those deemed by the researcher to be inadequate for inclusion in the study were excluded. The gynecologists (n = 125) were providing care in private practice (95% of cases) or in public hospitals. During the visit to the gynecologist, women were asked about their general and gynecological history and the presence of genitourinary symptoms. They also underwent a gynecological examination to evaluate the presence of vulvovaginal signs. The diagnosis of GSM was established for menopause-associated genital and urinary signs or symptoms (at least 2 symptoms, or 1 symptom and 1 sign) that were reported as bothersome, and which could not be attributed to other pathologies.1 Postmenopausal women who experienced at least 1 vaginal symptom, regardless of the symptom intensity, completed the “day-to-day impact of vaginal aging” (DIVA) questionnaire to assess the impact on well-being and QoL.18 Women completed the questionnaire (on paper) during the visit to the gynecologist, in private.
The study procedures were in accordance with the Declaration of Helsinki, and were approved by the Ethics Committees of Hospital Clínic de Barcelona (Spain), and Hospital Universitario Puerta de Hierro Majadahonda, Madrid (Spain).
Endpoints and variables
The primary endpoints included an assessment of the impact of vaginal symptoms (such as vaginal dryness, itching, irritation, soreness, and pain), on the QoL of postmenopausal women, in the last month. This was measured by having the participants fill out the DIVA questionnaire.18 The DIVA questionnaire was specifically developed for measuring the QoL of postmenopausal women with vaginal symptoms.18 It is composed of 23 items grouped into 4 domain scales: activities of daily living (items 1, 2, 3, 4, and 5), emotional well-being (items 6, 7, 8, and 9), sexual functioning short version (items: 10, 11, 12, 16, 17, and 18), sexual functioning long version (items 10, 11, 12, 13, 14, 15, 16, 17, and 18), and self-perception and body image (items 19, 20, 21, 22, and 23). The questionnaire included 2 versions (short and long) of the sexual functioning domain scale. The short version was completed by all of the women, regardless of their sexual activity status. The long version was provided only to sexually active women, that is, those who were sexually active in the last month. Each item was scored from 0 to 4 (0 = not at all, 1 = a little bit, 2 = moderately, 3 = quite a bit, and 4 = extremely). The total score of each domain scale was calculated by using the mean scores of the individual items. In the DIVA questionnaire, higher scores indicate a greater impact of vaginal symptoms on each domain scale. As the original version of the DIVA questionnaire is in English, we translated it into Spanish, following the respective conditions specified in the original paper,18 and maintaining its conceptual integrity.
The qualitative variables were expressed as absolute and relative (%) frequencies, whereas the quantitative ones were expressed as the mean with the standard deviation (SD). The mean scores for each domain scale of the DIVA questionnaire for women with and without GSM were compared using the nonparametric Wilcoxon signed-rank test. The statistical significance was defined as P < 0.05. All of the statistical procedures were performed using SAS version 9.3.
Overall characteristics of women
The characteristics of the 430 postmenopausal women who participated in the GENISSE study are shown in Table 1. The women had a mean age of 58.1 years (SD, 6.9 years), and they experienced their last menstruation 9.1 years (SD, 6.8 years) before inclusion in the study. They mainly had natural menopause (89.8%); 40.0% and 33.0% of them reported a very good or good opinion about their health status, respectively. Most of them (72.1%) were sexually active in the last month. A routine periodic check-up was the main reason for visiting the gynecologist (58.8%). A total of 40.9% of the women had a previous diagnosis of VVA or GSM, and 70.5% were diagnosed with VVA or GSM after seeing the gynecologist. A total of 423 experienced at least 1 vaginal symptom and were asked to fill out the DIVA questionnaire. Among them, 270 (63.8%) were sexually active in the last month. A total of 299 (70.7%) had vaginal symptoms and a diagnosis of GSM; whereas 124 (29.3%) had no diagnosis of GSM.
Impact of genitourinary syndrome of menopause on functioning, well-being, and quality of life
The mean scores on each of the domain scales of the DIVA questionnaire for all of the postmenopausal women who completed the questionnaire are shown in Figure 1. The highest mean scores were found in the long version of the sexual functioning domain scale (mean 1.8; SD 1.0), followed by the short version of the sexual functioning (mean 1.7; SD 1.1), the self-perception and body image (mean 1.4; SD 1.1), the activities of daily living (mean 0.7; SD 0.8), and the emotional well-being (mean 0.7; SD 0.9) domain scales. The mean scores on each of the domain scales of the DIVA questionnaire are shown in Figure 2. The scores on the DIVA questionnaire were significantly higher (P < 0.001) in women with a diagnosis of GSM than in women without the condition. The highest values of the questionnaire for both groups were found in the long version (mean 2.0; SD 1.0 in women with GSM vs mean 1.1; SD 0.9 in those without it) and the short version of sexual functioning domain scales (mean 1.9; SD 1.1 vs mean 1.1; SD 1.0). The lowest values for both groups were found in the activities of daily living (mean 0.8; SD 0.8 vs mean 0.3; SD 0.6), and the emotional well-being domain scales (mean 0.9; SD 0.9 vs mean 0.3; SD 0.6).
GSM has been shown to negatively impact daily living, sexuality, relationships, and QoL; as demonstrated in various surveys.12-15 The international VIVA (Vaginal health: Insights, Views & Attitudes) survey involved 3,520 postmenopausal women aged 55 to 65 years from Great Britain, the United States, Finland, Norway, Denmark, Canada, and Sweden.12 Authors found that 45% of women experienced vaginal symptoms, and 32% never sought help from a gynecologist. The majority of women (75%) indicated that vaginal atrophy negatively impacted their lives, especially sexual intimacy (64%), loving relationship with a partner (32%), overall QoL (32%), feeling healthy (21%), and feeling attractive (21%). Similarly, the CLOSER (Clarifying Vaginal Atrophy's Impact On SEx and Relationships) survey included 4,100 women, between 55 and 65 years with a history of vaginal atrophy, and 4,100 men from 9 countries (United Kingdom, Italy, Canada, the United States, Finland, Denmark, Norway, Sweden, and France).13 Main effects of vaginal atrophy were avoiding intimacy (62% of women), fewer sexual encounters (58%), less satisfying sex (49%), and putting off having sex (35%). Painful sex and reduced sexual desire were considered causes of intimacy avoidance in 55% and 46% of women, respectively. The REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs (REVIVE) survey involved 3,046 postmenopausal women from the United States with symptoms of vulvar and vaginal atrophy (mainly dryness, dyspareunia, and irritation).14 Their VVA symptoms negatively impacted enjoyment of sex (62%), sexual spontaneity (59%), ability to be intimate (58%), relationship with their partner (48%), sleep (24%), overall enjoyment of life (23%), and temperament (23%). The 12-week SMART-3 study (Selective estrogen Menopause And Response to Therapy 3) survey involved 664 postmenopausal women between 45 and 60 years of age with at least 1 moderate-to-severely bothersome vulvar-vaginal symptom (dryness, itching/irritation, or pain with intercourse).15 Authors evaluated the association between VVA endpoints and the sexual function domain of the Menopause-specific Quality of Life (MENQOL) questionnaire. The VVA symptoms were strongly related to MENQOL scores. In fact, results showed that a 1-point improvement in VVA vaginal symptoms (such as a reduction in severity) was significantly associated with changes in MENQOL score. The authors stated that clinicians can improve QoL related to sexual functioning by managing GSM symptoms.
The results from our present study (by using the validated DIVA questionnaire) are in concordance with the literature. Vaginal symptoms impacted the well-being, functioning, and QoL of our cohort of postmenopausal women from Spain. Greatest impacts were on sexual functioning, self-perception, and body image domain scales. Notably, sexually active women felt that their sexual functioning was affected by vaginal symptoms. It is well known that staying sexually active after menopause is important for overall well-being, and key for successful aging.4,19,20 Moreover, an association between sexual function and QoL has been demonstrated in various studies.14,15
Our results with the DIVA questionnaire also revealed that vaginal symptoms have a minor impact on the activities of daily living and the emotional well-being domain scales. Analyzing the domain scales related to the activities of daily living, they were noted to be mostly related to general aspects (not only to GSM), such as physical appearance due to the presence of hot flashes, or work activity, among others. In addition, the women may have misidentified emotional well-being status with their body image and self-perception, as many postmenopausal women assume vaginal symptoms to be factors associated with age.
Interestingly, all of the subdomains of the DIVA questionnaire (activities of daily living, emotional well-being, sexual functioning, and self-perception and body image) were consistently rated significantly higher in women with GSM than in those without GSM. This may translate into a relationship between GSM and the QoL of postmenopausal women, in line with various surveys and investigations in which GSM has been shown to produce a negative impact on activities of daily living, self-esteem, sex life, marriage or relationships, social life, and overall QoL.4 This finding is of particular clinical relevance because women diagnosed with GSM should be treated: not only to solve their vaginal problems, but, more importantly, to improve their self-esteem, sexual and emotional well-being, and various other aspects of their QoL.4 Treatment with long-acting vaginal moisturizers or low-dose vaginal estrogen has been shown to achieve a significant improvement in sexual health and QoL.5 One-point differences in sexual functioning and self-perception domain scales are relevant in this population of middle-aged and older women, in which QoL gains particular importance.
On the contrary, the GENISSE study also revealed important issues that need to be taken into account in the diagnosis and management of GSM.16 Approximately 70% of postmenopausal women seeking a gynecologist's opinion are ultimately diagnosed with GSM. Only 40% of postmenopausal women referred to a gynecologist had a prior diagnosis. The study also showed that GSM goes undetected in the population, as diagnosed when visiting a gynecologist during a routine check-up. This is in concordance with other studies reported previously.9,12,21 Women do not correlate this symptomatology with a decrease in estrogen and sexual steroids (ie., a chronic condition), but they consider it to be a result of the natural aging process. Indeed, only approximately 1 in 4 women experiencing GSM symptoms seeks medical assistance.22 Altogether, these results highlight the importance of adequate diagnosis and management of GSM for maintaining the well-being and QoL of women in this stage of life.
It is important for gynecologists, nurse practitioners, and primary care doctors to be aware of the major impact of this syndrome on well-being and QoL of postmenopausal women. They should routinely assess perimenopausal and postmenopausal women for GSM and sexual activities. Because of their specialization in the female genital tract and reproductive health, gynecologists are the doctors who most frequently deal with patients’ sexual problems. Unfortunately, sexual issues are usually avoided in medical consultations.23 Gynecologists, nurse practitioners, and primary care doctors should help their patients understand that GSM is a chronic condition that requires proper management and which will have an integral effect on postmenopausal woman. The use of validated questionnaires (such as the DIVA) can guide health professionals as they treat, manage, and monitor these women.
One limitation of the study was that gynecologists mainly came from private practices (95%). Although the information shown in the present study is relevant, by including postmenopausal women who were attended in public healthcare centers could strengthen the conclusions. In fact, we believe that the prevalence of women with GSM in clinical practice might be higher than reported. Another limitation of the study was the absence of a validation study for the Spanish version of DIVA questionnaire to provide reliability for the results obtained in the Spanish population.
Vaginal symptoms impact the well-being, functioning, and QoL of postmenopausal women, especially their sexual function, self-perception, and body image. This impact is significantly higher in women with GSM. Up to 70% of postmenopausal women are affected by GSM: a condition that can be adequately managed with available treatments. It is highly likely that treating their GSM would result in an improvement of the affected women's QoL. This needs to be proven in further prospective studies involving larger cohorts of postmenopausal women and different treatment groups.
Additional participants in the GENISSE study were as follows: M.F. Oltra (Alicante), E.M. Contreras (Cádiz), R. León (Cádiz), C. González (Sevilla), M.I. Massé (Sevilla), E. Flores (Sevilla), R. Rodríguez (Orense), I. Lago (Pontevedra), A.M. González (Vigo), O. Valenzuela (Vigo), M. Villegas (Barcelona), A. Jordán (Barcelona), B. Meneses (Barcelona), I. Núñez (Barcelona), C.J. Pace (Barcelona), P. Beroiz (Barcelona), A. Martí (Barcelona), J.G. Hernández (Santa Cruz de Tenerife), L. González (Santa Cruz de Tenerife), M. Muñoz (Barcelona), J.R. Méndez (Barcelona), S. González (Barcelona), V. Rayo (Barcelona), M. Amorós (Barcelona), J.R. Rodríguez (Barcelona), C. Pedrosa (Granada), R. Herrera (Málaga), J. García (Málaga), R. Laza (Málaga), M.C. Rodríguez (Granada), A. Jarque (León), J.L. Solís (Oviedo), L. Vior (Oviedo), C.M. Rodríguez (Asturias), J.V. Carmona (Valencia), J. Server (Valencia), M. González (Valencia), L.J. Matute (Valencia), F. Ridocci (Valencia), R.V. García (Valencia), J. Moro (Salamanca), C.E. García (Zamora), M.J. Velasco (Ávila), A. Martín (Burgos), J.I. González (Valladolid), J. Velasco (Valladolid), C. Oliva (Castellón), A. Estrada (Valencia), D. Mares (Valencia), F. Ruiz (Valencia), C. Vignardi (Madrid), M.A. Martínez (Madrid), J. Lázaro (Madrid), A. Palacín (Madrid), L. San Frutos (Madrid), J.A. Navas (Córdoba), J.J. Hijona (Jaén), E. Velasco (Córdoba), M. Pérez (Lugo), M.J. Carballo (La Coruña), C. González (La Coruña), G. Tejada (Albacete), L. Sánchez (Ciudad Real), C. Martín (Toledo), M. Rey (Islas Baleares), V.H. Chávez (Islas Baleares), M.C. González (Madrid), A.R. Masero (Madrid), I. Ramírez (Madrid), C. Martín-Ondarza (Madrid), E. Vizcaíno (Madrid), N. Ros (Tarragona), A. Calvo (Lérida), J.C. Riera (Gerona), J. Salinas (Tarragona), F.R. Blanco (Badajoz), J.A. Sánchez (Badajoz), A. Monrobel (Cáceres), S. Escudero (La Rioja), A. López (Huesca), M.P. del Tiempo (Zaragoza), C.J. Elorriaga (Zaragoza), C. Ceballos (Cantabria), J. Oraa (Vizcaya), F. Mozo (Vizcaya), B. Otero (Vizcaya), T.M. Diaz (Vizcaya), S. Andreu (Madrid), L. Almarza (Madrid), R. Rodríguez (Guadalajara), M. Puch (Madrid), A. Hernández (Madrid), J. de la Fuente (Madrid), M. Ferrero (Barcelona), A. Reus (Barcelona), M. Guinot (Barcelona), M. Muñoz (Barcelona), A. Bernad (Barcelona), A. Torrent (Barcelona), V. Turrado (Barcelona), I. Etxabe (Guipúzcoa), I. Fernández (Navarra), M. Martínez (Álava), M.C. Castro (Murcia), J. Rodríguez (Alicante), C. González (Alicante), V. M. Lago (Murcia), R. Lorente (Alicante), M.A. Nieto (Las Palmas), M. Sosa (Las Palmas), M. Montero (Huelva), M.M. Falcón (Sevilla), A. Polo (Sevilla), S. Cruz (Madrid), and M. Rius (Barcelona).
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