Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pelvify: Menopause and dyspareunia treatment, Face to Face Physical Therapy Protocol, Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program.
- Who it may be relevant to
- Registry conditions: Menopause, Genitourinary Syndrome of Menopause, Dyspareunia. Basic parameters: 45 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women With Dyspareunia: Protocol of a Randomized Clinical Trial.
Overview
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.
Interventions
- 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.
Primary outcome measures
- Improved Female Sexual Function via Female Sexual Function Index (FSFI) [Time frame: 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) [Time frame: 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) [Time frame: 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 outcome measures (1)
- Change from the size of the Vaginal Dilator inserted without pain [Time frame: From enrollment to one week after treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- RAPbarcelona — Barcelona
Publications
- 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
Identifiers
NCT: NCT06710002 · RAPbarcelonaPAULA