MenopauseGenitourinary Syndrome of MenopauseDyspareunia
Investigational drug(s) / intervention(s)
Pelvify: Menopause and dyspareunia treatmentFace to Face Physical Therapy ProtocolFace to Face Protocol Combined With an Asynchronous Telerehabilitation Program
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.
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.
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.
Study 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.
Eligibility
Sex
FEMALE
Min age
45 Years
Max age
65 Years
Healthy volunteers
No
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.
* 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).
* Neurological or metabolic conditions that affect the ability to respond (Diabetes, Parkinson's disease, senile dementia, etc).
* Serious mental disorder.
Primary outcome measure(s)
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 of any domain is less than 3.6 points, is considered a risk criterion for sexual dysfunction.
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 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.
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). The total score is from 29 to 232 points. A higher score indicates more intense symptomatology.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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