Genitourinary Syndrome of Menopause.
Jean M Marino
https://pubmed.ncbi.nlm.nih.gov/34464022Actively Recruiting
Phase Not Applicable
Age: 45Years - 65Years
FEMALE
ID06710002
Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women With Dyspareunia
Led by Instituto Médico Tecnológico SL · Updated on 2025-05-23
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Instituto Médico Tecnológico SL
Lead Sponsor
R
RAPbarcelona
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a telerehabilitation program compared to face-to-face physiotherapy in improving sexual function, reducing pain, and enhancing quality of life in menopausal women with dyspareunia. The study aims to determine if an asynchronous online telerehabilitation program is not less effective than traditional face-to-face treatment, using tools like the Female Sexual Function Index (FSFI), Visual Analogue Scale (VAS), and Menopause Specific Quality of Life Questionnaire (MENQOL). Secondary goals include assessing combined treatment benefits, vaginal dilator size changes, adverse effects, treatment adherence, and participant satisfaction. Participants will be assigned to one of three groups: an online telerehabilitation program called "Pelvify: Menopause and dyspareunia treatment," a face-to-face physical therapy protocol involving manual therapy and radiofrequency treatment, or a combination of both. Each intervention lasts five weeks, with sessions including explanatory videos or individual physiotherapy visits weekly. All participants will have a face-to-face assessment in the sixth week, followed by telephone check-ins six and twelve months after treatment completion. During the study, participants will complete questionnaires evaluating sexual function, pain levels, and quality of life at baseline, after five weeks, one week post-treatment, and at six and twelve months follow-up. Researchers will also monitor vaginal dilator size changes, adherence to treatment plans, and any adverse effects. The total involvement includes initial treatment, follow-up visits, and long-term telephone monitoring to assess sustained outcomes.
CONDITIONS
Brief Title
Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women
Who Can Participate
Age: 45Years - 65Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Female
- Age from 45 to 65 years
- Menopausal
- Experiencing dyspareunia for at least 3 months
- Willing to complete study questionnaires and provide informed consent
You will not qualify if you...
- Presence of pacemaker or other electronic implants
- Thrombophlebitis
- Skin hypersensitivity or rejection of manual contact
- Active or previous chemotherapy or radiotherapy in pelvic area
- Wounds or burns in pelvic area
- Allergy to nickel and chromium
- Receiving other pelvic floor physiotherapy treatments during study
- Receiving other medical or surgical pelvic treatments during study
- Pelvic surgery within last 3 months
- Fibromyalgia
- Oncological conditions affecting sacrum
- Systemic infectious, vascular, endocrine, metabolic, or neoplastic diseases
- Neuromuscular diseases such as ALS, MS, Myasthenia Gravis, or spinal muscular atrophy
- Myelopathy or osteomyelitis
- Central nervous system disorders like spinal cord injury
- Neurological or metabolic conditions affecting response ability (e.g., Diabetes, Parkinson's disease, dementia)
- Serious mental disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 weeks
Participants receive one of three interventions: an asynchronous online telerehabilitation program, a face-to-face physical therapy protocol, or a combination of both. The treatment aims to improve sexual function and reduce pain related to dyspareunia during menopause.
Weekly visits for up to 5 weeks and 1 face-to-face assessment visit in the sixth week
Follow-up
Duration - 6 to 12 months after treatment
Participants receive telephone follow-up calls to assess progress and outcomes at 6 months and 12 months after treatment completion.
2 telephone follow-up calls
Trial Site Locations
Total: 1 location
1
RAPbarcelona
Barcelona, Spain, Spain, 08037
Actively Recruiting
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Research Team
P
Paula Sanfeliu Rosell, MSc
I
Inés Ramírez García, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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