Clinical trial NCT03558451: Multicentre Clinical Trial. Project EXIMe
Official title: Effectiveness of a Sexual Health Intervention in Women With Genitourinary Syndrome of Menopause to Improve Their Quality of Life. Multicentre Clinical Trial. Project EXIMe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Primary health care
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
Collaborators: name: Fundación de Innovación e Investigación Biomédica de Atención Primaria-Madrid
First posted: 2018-06-15
Enrollment: 250
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Main-Quality of life in menopause
timeFrame: Change from baseline Quality of life at six months
Secondary outcomes:
measure: Sexual function
timeFrame: Change from baseline at six months
measure: vaginal pH
timeFrame: Change from baseline at six months
measure: Oxford scale
timeFrame: Change from baseline at six months
measure: Urine sediment
timeFrame: Change from baseline at six months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gerencia de Atención Primaria, Madrid
Study officials:
affiliation: Gerencia de Atención Primaria, Madrid
name: Lucia Martinez-Villarejo, Midwife
role: PRINCIPAL_INVESTIGATOR
References: