Multicentre Clinical Trial. Project EXIMe (EXIMe)

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

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.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Other: Complex intervention in sexual health; Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28035
    • Gerencia de Atención Primaria, Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EXIMe intervention; 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; 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; Other: Usual care; According to available protocols applicable to the patient and the health service standardized portfolio; Other Names: Women will receive the usual assistance
ACTIVE_COMPARATOR: Usual care; Usual care according to available protocols applicable to the women and the health service standardized portfolio	Other: Usual care; According to available protocols applicable to the patient and the health service standardized portfolio; Other Names: Women will receive the usual assistance

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gerencia de Atención Primaria, Madrid
• Collaborators: Fundación de Innovación e Investigación Biomédica de Atención Primaria-Madrid
• Investigators: Principal Investigator: Lucia Martinez-Villarejo, Midwife, Gerencia de Atención Primaria, Madrid

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 10, 2017
• Primary Completion (ACTUAL): October 15, 2018
• Study Completion (ACTUAL): March 15, 2019

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (ACTUAL): June 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Primary health care
• Other Study ID Numbers: CCI 24/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No