Multicentre Clinical Trial. Project EXIMe

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of a Sexual Health Intervention in Women With Genitourinary Syndrome of Menopause to Improve Their Quality of Life. Multicentre Clinical Trial. Project EXIMe

Conditions
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Menopause

Intervention / Treatment
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* Other: Complex intervention in sexual health
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXIMe intervention<br>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. | Other: Complex intervention in sexual health<br>* 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.<br>* Other names: Usual care;Other: Usual care<br>* According to available protocols applicable to the patient and the health service standardized portfolio<br>* Other names: Women will receive the usual assistance;|
| Active Comparator: Usual care<br>Usual care according to available protocols applicable to the women and the health service standardized portfolio | Other: Usual care<br>* According to available protocols applicable to the patient and the health service standardized portfolio<br>* Other names: Women will receive the usual assistance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main-Quality of life in menopause | Main-Quality of life in menopause measured with Cervantes Short-Form Scale (20 -100 points) | Change from baseline Quality of life at six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual function | Sexual function: measured with Questionnaire Health and female sexual dysfunction in primary care | Change from baseline at six months | 
| vaginal pH | vaginal pH | Change from baseline at six months | 
| Oxford scale | Oxford scale: pelvic floor muscle response | Change from baseline at six months | 
| Urine sediment | Urine sediment | Change from baseline at six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary health care