A new questionnaire being developed through a collaboration between the Massachusetts General Hospital (MGH) Midlife Women’s Health Center and the North American Menopause Society is designed to improve knowledge of the extent and impact on women of genitourinary symptoms of menopause. The progress of the collaboration, which has the ultimate goal of bring effective treatments to more women, is described in a paper that will appear in the April issue of the journal Menopause and has been released online.
“The genitourinary syndrome of menopause includes symptoms of vaginal dryness and pain affecting sexual activity, urination and activities of daily life. Although it can have a significant effect on the sex lives and the overall quality of life of menopausal women, current knowledge about the syndrome is limited because we lack a simple, validated measure to assess the problem in large groups of women,” says Jan Shifren, MD, director of the MGH Midlife Women’s Health Center, corresponding author of the report. “Reliable information on its prevalence and modifying factors is needed to raise awareness and increase the numbers of women receiving effective treatment.”
The paper’s authors note that women with these symptoms often are not aware that effective treatments are available – including vaginal lubricants, moisturizers, and low-dose vaginal estrogen therapy. Women often consider their bothersome symptoms to be a normal part of aging that must be accepted. Such beliefs, along with embarrassment, may keep women from discussing symptoms with health care providers; and in turn, clinicians without expertise in the care of menopausal women may not ask about them due to lack of awareness, time constraints and uncertainty about the safety and effectiveness of treatments.
The Vulvovaginal Atrophy Questionnaire (VVAQ) is being developed for clinical use and as a research tool for both epidemiologic studies and clinical trials assessing the efficacy of new therapies. The initial stages of development brought together existing knowledge about the syndrome, the input of experts in the care of menopausal women and – most importantly – the perspectives and experiences of women themselves. After developing an initial conceptual model, the team recruited 36 women in whom the genitourinary syndrome of menopause had been confirmed by both clinical examination and laboratory testing. The women participated in interviews regarding their symptoms and sensations, and the impact of symptoms on sexual function, intimate relationships, and their overall quality of life and well-being.
Among interviewed women, 86 percent indicated that symptoms impacted their sexual functioning, and 83 percent reported negative effects on their overall quality of life. The most commonly reported symptoms were pain with sexual activity, reported by 92 percent, and vaginal dryness (86 percent) and irritation (50 percent). Pain with sexual activity – described by some women as “excruciating,” and vaginal dryness were rated as particularly bothersome, with dryness affecting both sexual activity and activities of daily living.
Based on those interviews, the team developed an initial questionnaire, often incorporating terminology and expressions women used in their interviews. The initial questionnaire was then tested in nine focus groups – five with a total of 26 women with the syndrome and four with a total of 15 women without symptoms. Interviewers asked focus group participants whether the draft reflected their experiences, assessed how understandable the items and instructions were, and asked for suggestions about additional items to include. Although focus group conversations did lead to some revision of the initial version to clarify ambiguous language or reduce redundancies, most participants had a positive impression of the questionnaire, indicating that the questions were relevant and meaningful to their experiences.
“While women’s descriptions of the impact of their symptoms were not surprising to me, as a menopause specialist, we’re hopeful that their experiences will help inform clinicians who do not specialize in this area of the significance of the problem,” says Shifren, who is the Vincent Trustees Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School. “Many clinicians do not realize that genitourinary symptoms of menopause are a problem even for women who are not sexually active, affecting their ability to exercise, travel, or interact with family and friends.
“Once we are able to validate the VVAQ in a larger study, it will be made freely available to clinicians and researchers,” she continues. “This will enable us and others to determine the prevalence and impact of the genitourinary syndrome of menopause in large groups of women and assess factors and conditions that may improve or worsen the problem. What we learn from those studies should help us improve treatment for all women affected by this problem.”
The co-authors of the Menopause paper are Rebekah Zincavage, PhD, Ellen Cho, Ashley Magnavita, MPH, and Raymond Rosen, PhD, New England Research Institutes; David Portman, MD, Sermonix Pharmaceuticals; Michael Krychman, MD, Southern California Center for Sexual Health Survivorship Medicine; James Simon, MD, Women’s Health and Consultants, Washington, DC; and Sheryl Kingsberg, PhD, University Hospitals Cleveland Medical Center. The study was supported by the Vulvovaginal Aging Research Group, which includes the North American Menopause Society, the MGH Midlife Women’s Health Center, Pfizer, Shionogi and Allergan.
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH Research Institute conducts the largest hospital-based research program in the nation, with an annual research budget of more than $900 million and major research centers in HIV/AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, genomic medicine, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, photomedicine and transplantation biology. The MGH topped the 2015 Nature Index list of health care organizations publishing in leading scientific journals and earned the prestigious 2015 Foster G. McGaw Prize for Excellence in Community Service. In August 2018 the MGH was once again named to the Honor Roll in the U.S. News & World Report list of "America's Best Hospitals."
Press ReleaseJan | 7 | 2019