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

What this trial studies

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.

Conditions in scope

• Menopause
• Genitourinary Syndrome of Menopause
• Dyspareunia

Interventions

• Pelvify: Menopause and dyspareunia treatment (Behavioral) — 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.…
• Face to Face Physical Therapy Protocol (Other) — 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…
• Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program (Other) — Both, the face to face protocol and the Asynchronous Telerehabilitation Program will be carried on on this group.

Who can join

Women only · Ages 45 Years to 65 Years

Inclusion criteria

• Female
• Age from 45 to 65 years.
• Menopausal
• Suffer dyspareunia for 3 months of evolution.
• Willing to complete study questionnaires and informed consent study.

Exclusion criteria

• Pacemaker or other types of electronic implant.
• Thrombophlebitis.
• Skin hypersensitivity or rejection of manual contact.
• Active or previous treatment with chemotherapy or radiotherapy in the pelvic area.
• Wounds or burns in the pelvic area.
• Allergy to nickel and chromium.
• Other pelvic floor physiotherapy treatments during the study intervention.
• Other medical and surgical treatments in the pelvic region, such as muscle infiltrations or nerve blocks during the study intervention.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-05-05
• Primary completion: 2026-03
• Last update posted: 2025-05-23
• First posted: 2024-11-29

Sponsor & contact

Lead sponsor: Instituto Médico Tecnológico SL (Other)

Collaborators: RAPbarcelona

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Improved Female Sexual Function via Female Sexual Function Index (FSFI) (From registration to the end of treatment at 5 weeks, one week after the end of treatment, and at 6 and 12 months post-treatment)
  FSFI it is a self-administered instrument made up of 19 questions grouped into 6 domains: desire, arousal, lubrication, orgasm, satisfaction and pain. Response is measured on a scale from 0 (no sexual activity) to 5 (almost always). The FSFI total score range is 2 to 36; a score of less than or equal to 26.55 points, or when the score…
• Reduction in the Intensity of Dyspareunia Pain via Visual Analogue Scale (VAS) (From enrollment to the end of treatment at 5 weeks, one week after treatment, and at six months and twelve months post treatment)
  This scale (VAS) adequately captures the intensity of pain perceived by the patient represented by a horizontal line of 10 cm, where the left end (0 cm) is the absence of pain and the right end (10 cm) is pain of maximum intensity possible. The patient is asked to mark on the line the point indicating the intensity of their…
• Improved Quality of Life via Menopause Specific Quality of Life Questionnaire (MENQOL) (From registration to the end of treatment at 5 weeks, one week after the end of treatment, and at 6 and 12 months post-treatment)
  MENQOL it is a questionnaire designed to assess the quality of life of women who are going through menopause. It consists of 29 questions grouped into 4 domains: vasomotor area, psychosocial area, physical area and sexual area. Each question has two answer options No/Yes, if yes, it is assigned a score ranging from 0 (not annoying) to 6 (very annoying).…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.