Menopause
Conditions
Keywords
Primary health care
Brief summary
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.
Detailed description
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.
Interventions
OTHERComplex intervention in sexual health
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.
OTHERUsual care
According to available protocols applicable to the patient and the health service standardized portfolio
Sponsors
Fundación de Innovación e Investigación Biomédica de Atención Primaria-Madrid
Gerencia de Atención Primaria, Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Only primary care midwives know and apply the intervention
Intervention model description
Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* women aged between 45-65 years with Genitourinary Syndrome of Menopause
Exclusion criteria
* women who present pathologies that lead to an alteration of sexual desire * women who receive or have received in the last six months treatment that increase the incidence of vaginal atrophy * women who receive or have received local hormonal therapy during the last month, systemic hormonal therapy in the last six months, or other systemic treatment for the Genitourinary Syndrome of Menopause * women who could not read or write, and not understand the spanish language.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main-Quality of life in menopause | Change from baseline Quality of life at six months | Main-Quality of life in menopause measured with Cervantes Short-Form Scale (20 -100 points) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual function | Change from baseline at six months | Sexual function: measured with Questionnaire Health and female sexual dysfunction in primary care |
| vaginal pH | Change from baseline at six months | vaginal pH |
| Oxford scale | Change from baseline at six months | Oxford scale: pelvic floor muscle response |
| Urine sediment | Change from baseline at six months | Urine sediment |
Countries
Spain
Outcome results
None listed