NCT06710002

Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women

Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women With Dyspareunia: Protocol of a Randomized Clinical Trial.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Instituto Médico Tecnológico SL · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to analyze the effectiveness of a telerehabilitation program with respect to a face-to-face physiotherapy protocol in relation to the improvement of sexual function, the reduction of pain and the improvement of the quality of life, in the treatment of menopausal women with dyspareunia.

Detailed description

Both therapies have been proven to be effective, but since now any randomized controlled trial has been conducted to compare the results regarding the improvement in the sexual function, the reduction of pain and the improvement of quality of life in this population. The investigators hypothesize that the implementation of an asynchronous online telerehabilitation program is not inferior to the effect of the treatment carried out with a face-to-face physiotherapy protocol, in relation to the main variables obtained with the instruments Female Sexual Function Index (FSFI), the Visual Analogue Scale (VAS) and Menopause Specific Quality of Life Questionnaire (MENQOL). Secondary goals are: 1) to evaluate whether the incorporation of a telerehabilitation program to face-to-face treatment increases the effectiveness in relation to performing only the face-to-face physiotherapy protocol, 2) compare the size of the vaginal dilator inserted painlessly at the end of the treatment in all groups, 3) identify any adverse effects associated with the intervention during the study, 4) detail the degree of adherence to the treatment and 5) record satisfaction with the treatment using the Likert Scale.

Conditions

• Menopause
• Genitourinary Syndrome of Menopause
• Dyspareunia

Interventions

Type	Name	Description
BEHAVIORAL	Pelvify: Menopause and dyspareunia treatment	Topics addressed in the Asynchronous Online Telerehabilitation Program would be: 1. What it is and why it hurts during sex. What is dyspareunia? 2. How to recover vaginal elasticity. 3. Massage 4. Self-palpation. 5. Stretching of the pelvic floor muscles. 6. Use of vaginal dilators. 7. Moisturizers and lubricants. 8. Sexual pleasure. 9. Communication with the partner.
OTHER	Face to Face Physical Therapy Protocol	Physical Therapy Protocol will be based on: 1. Health education: 2. CMRF: INDIBA® ACTIV CT8 will be used to apply the radiofrequency 3. Manual therapy: it will be based on performing the Thiele's massage. 4. Vaginal dilators: FEMINAFORM® vaginal dilators will be used.
OTHER	Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program	Both, the face to face protocol and the Asynchronous Telerehabilitation Program will be carried on on this group.

Timeline

• Start date: 2025-05-05
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-11-29
• Last updated: 2025-05-23

Locations

1 site across 1 country: Spain