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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM)

NCT07034976

Genitourinary Syndrome of Menopause (GSM) Breast Cancer

RECRUITING NA

The Effects of Lateralized Thermal Sleepwear on Sleep, Skin Temperature and Skin Moisture in Menopausal Women

NCT03037554

Menopause Related Conditions

TERMINATED NA

Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors

NCT05713435

Genitourinary Syndrome of Menopause

RECRUITING NA

Nursing Interventions to Enhance Positive Mental Health and Self Care in Women During the Climacteric

NCT07165964

Climacteric Symptoms Climactericum Self Care

ACTIVE_NOT_RECRUITING NA

Low-level Laser Therapy in Genitourinary Symptoms of Menopause

NCT06074120

Menopause Related Conditions

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menopause Genitourinary Syndrome of Menopause Dyspareunia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Asynchronous Online Telerehabilitation Program

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.

Group Type EXPERIMENTAL

Pelvify: Menopause and dyspareunia treatment

Intervention Type 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.

Face to Face Physical Therapy Protocol

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.

Group Type ACTIVE_COMPARATOR

Face to Face Physical Therapy Protocol

Intervention Type 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 Protocol Combined With an Asynchronous Telerehabilitation Program

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.

Group Type ACTIVE_COMPARATOR

Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program

Intervention Type OTHER

Both, the face to face protocol and the Asynchronous Telerehabilitation Program will be carried on on this group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No