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

NCT06710002 | Recruiting

• 1 other identifier: RAPbarcelonaPAULA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause; Genitourinary Syndrome of Menopause; Dyspareunia

Keywords

Physiotherapy; Telerehabilitation; face to face treatment; female sexual function; vaginal dilators; manual therapy; capacitive resistive monopolar radiofrequency

Outcome Measures

Primary Outcomes (3)

• Improved Female Sexual Function via Female Sexual Function Index (FSFI)

  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 of any domain is less than 3.6 points, is considered a risk criterion for sexual dysfunction.

  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

• Reduction in the Intensity of Dyspareunia Pain via Visual Analogue Scale (VAS)

  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 pain and it is measured with a millimeter ruler. The intensity is expressed in centimeters. It is considered mild up to 4 cm, moderate from 5 to 7 cm and if it is greater than 7 cm.

  From enrollment to the end of treatment at 5 weeks, one week after treatment, and at six months and twelve months post treatment

• Improved Quality of Life via Menopause Specific Quality of Life Questionnaire (MENQOL)

  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). The total score is from 29 to 232 points. A higher score indicates more intense symptomatology.

  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

Secondary Outcomes (1)

• Change from the size of the Vaginal Dilator inserted without pain

  From enrollment to one week after treatment

Other Outcomes (3)

• Number of complaints or adverse effects registered during treatments

  During the five weeks of treatment and one week after finishing it.

• Degree of Satisfaction Score on the treatment using the Likert Scale.

  One week after the end of treatment, and 6 months and 12 months after treatment

• Degree of Adherence to the treatments

  During the five weeks of treatment, 1 week after treatment, and at 6 months and 12 months after treatment

Study Arms (3)

Asynchronous Online Telerehabilitation Program

EXPERIMENTAL

For this study, a five weeks course called "Pelvify: Menopause and dyspareunia treatment" will be created. This will be based on a set of explanatory and demonstrative videos focused on self-treatment of pain during sexual intercourse. Each patient will have an individual access (own user). All groups in the sixth week will have a face-to-face visit to assess their progress. A telephone follow-up will be carried out at six months and twelve months after the end of the treatment.

Behavioral: Pelvify: Menopause and dyspareunia treatment

Face to Face Physical Therapy Protocol

ACTIVE COMPARATOR

This consists of carrying out 5 individual sessions of 45 minutes, 1 day a week at the physiotherapy clinic RAPbarcelona S.L. Patients will be placed comfortably supine with a pillow under their head, with their legs flexed on two leg warmers, in the lithotomy position, without underwear and covered with a drape. In each of the treatment sessions, the same structure will always be applied and the established protocol will be followed. All groups in the sixth week will have a face-to-face visit to assess their progress. A telephone follow-up will be carried out at six months and twelve months after the end of the treatment.

Other: Face to Face Physical Therapy Protocol

Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program

ACTIVE COMPARATOR

This group will carry out the same 5 individual sessions of 45 minutes, 1 day a week at the RAPbarcelona S.L physiotherapy clinic following the protocol described for the "Face to Face Physical Therapy Protocol" group and in addition to the first visit they will be given access and instructions to follow in parallel the asynchronous online telerehabilitation program "Pelvify: Menopause and dyspareunia treatment". All groups in the sixth week will have a face-to-face visit to assess their progress. A telephone follow-up will be carried out at six months and twelve months after the end of the treatment.

Other: Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program

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. 6. Use of vaginal dilators. 7. Moisturizers and lubricants. 8. Sexual pleasure. 9. Communication with the partner.

Asynchronous Online Telerehabilitation Program

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 will be used.

Face to Face Physical Therapy Protocol

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.

Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Surgical intervention in the pelvic area in the last 3 months.
• Fibromyalgia.
• Oncological processes that affect the sacrum.
• Systemic diseases (infectious, vascular, endocrine, metabolic or neoplastic conditions).
• Neuromuscular diseases (Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Myasthenia Gravis or spinal muscular atrophy).
• Myelopathy and Osteomyelitis.
• Diseases that cause alterations of the central nervous system (traumatic or vascular spinal cord injury).

Sponsors & Collaborators

• Instituto Médico Tecnológico SL: lead
• RAPbarcelona: collaborator

Study Sites (1)

RAPbarcelona

Barcelona, Spain, 08037, Spain

RECRUITING

Related Publications (1)

• Marino JM. Genitourinary Syndrome of Menopause. J Midwifery Womens Health. 2021 Nov;66(6):729-739. doi: 10.1111/jmwh.13277. Epub 2021 Aug 31.

  PMID: 34464022 BACKGROUND

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Paula Sanfeliu Rosell, MSc

CONTACT

+34 648222751; fisiopaulasanfeliu@gmail.com

Inés Ramírez García, PhD

CONTACT

+34 677745765; iraga73@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Professor. Physiotherapist PhD

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 29, 2024
• Study Start: May 5, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)