Clinical trial NCT06710002: Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Instituto Médico Tecnológico SL
Sponsor class: OTHER
Collaborators: name: RAPbarcelona
First posted: 2024-11-29
Enrollment: 90
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Improved Female Sexual Function via Female Sexual Function Index (FSFI)
timeFrame: 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
measure: Reduction in the Intensity of Dyspareunia Pain via Visual Analogue Scale (VAS)
timeFrame: From enrollment to the end of treatment at 5 weeks, one week after treatment, and at six months and twelve months post treatment
measure: Improved Quality of Life via Menopause Specific Quality of Life Questionnaire (MENQOL)
timeFrame: 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:
measure: Change from the size of the Vaginal Dilator inserted without pain
timeFrame: From enrollment to one week after treatment
Other outcomes:
measure: Number of complaints or adverse effects registered during treatments
timeFrame: During the five weeks of treatment and one week after finishing it.
measure: Degree of Satisfaction Score on the treatment using the Likert Scale.
timeFrame: One week after the end of treatment, and 6 months and 12 months after treatment
measure: Degree of Adherence to the treatments
timeFrame: During the five weeks of treatment, 1 week after treatment, and at 6 months and 12 months after treatment
Locations:
city: Barcelona
country: Spain
facility: RAPbarcelona
Study officials:
References:
citation: 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.