Gerencia de Atención Primaria, Madrid
Madrid, 28035, Spain
NCT Number: NCT03558451
Objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with Genitourinary Syndrome of Menopause. Design: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid.
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Notify Me45 year–65 year
Female
Interventional
Not applicable
Madrid, 28035, Spain
Genitourinary Syndrome of Menopause is a common condition that increases by four the risk of having a sexual dysfunction, and that affects the quality of life of women who suffer it. Those women with an active sexual life have fewer symptoms associated with this syndrome. Objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with Genitourinary Syndrome of Menopause. Design: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid. Population: women aged between 45-65 years with Genitourinary Syndrome of Menopause attending to the midwife consultation. N= 250 (125 women in each group) will be included by midwifes in the Primary Health Care consultations in the Community of Madrid. Control group: women will receive the usual assistance.
Experimental group: in addition to the usual assistance, women will receive a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used. Variables: Main-Quality of life in menopause (measured with the Cervantes Short-Form Scale). Secondary- sociodemographic variables, sexual history and variables related to the Genitourinary Syndrome of Menopause. Analysis: by intention-to-treat, comparing the quality of life in menopause scores before/after the intervention in both groups after 0, 1 and 6 months. To explain the factors associated with a higher quality of life, a linear regression model would be fitted.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EXIMe is a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used.
Other names: Usual care
According to available protocols applicable to the patient and the health service standardized portfolio
Other names: Women will receive the usual assistance
Time frame: Change from baseline Quality of life at six months
Main-Quality of life in menopause measured with "Cervantes Short-Form Scale" (20 -100 points)
Time frame: Change from baseline at six months
Sexual function: measured with Questionnaire "Health and female sexual dysfunction in primary care"
Time frame: Change from baseline at six months
vaginal pH
Time frame: Change from baseline at six months
Oxford scale: pelvic floor muscle response
Time frame: Change from baseline at six months
Urine sediment
Gerencia de Atención Primaria, Madrid
Other Gov
Effectiveness of a Sexual Health Intervention in Women With Genitourinary Syndrome of Menopause to Improve Their Quality of Life. Multicentre Clinical Trial. Project EXIMe
Acronym: EXIMe
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