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

Instituto Médico Tecnológico SL

Status: Enrolling

Conditions: Dyspareunia; Menopause; Genitourinary Syndrome of Menopause

Treatments: Other: Face to Face Physical Therapy Protocol; Other: Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program; Behavioral: Pelvify: Menopause and dyspareunia treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06710002

RAPbarcelonaPAULA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Asynchronous Online Telerehabilitation Program

Experimental group

Description:

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.

Treatment:

Behavioral: Pelvify: Menopause and dyspareunia treatment

Face to Face Physical Therapy Protocol

Active Comparator group

Description:

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.

Treatment:

Other: Face to Face Physical Therapy Protocol

Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program

Active Comparator group

Description:

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.

Treatment:

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