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

Not Applicable

Recruiting

• Conditions: Menopause; Genitourinary Syndrome of Menopause; Dyspareunia

• Registration Number: NCT06710002
• Lead Sponsor: Instituto Médico Tecnológico SL

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.

Study Timeline

• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-29
• Status Verified: 2025-05
• Study Start: 2025-05-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Change from the size of the Vaginal Dilator inserted without pain	From enrollment to one week after treatment	It will be measured with FEMINAFORM® vaginal dilators. The set consists of 4 dilators of different diameters and lengths, and a clamping device: Size 1: 22mmx85mm (diameter/length), Size 2: 27x105mm (diameter/length), Size 3: 32x135mm (diameter/length) and Size 4 : 37x160mm (diameter/length).; The largest vaginal dilator size that has a score (VAS) of 0 cm will be recorded. It will be specified whether the absence of pain is by inserting the entire dilator or only a part.

Trial Locations

Locations (1)

RAPbarcelona; 🇪🇸 Barcelona, Spain