Genitourinary Syndrome of Menopause.
Jean M Marino
https://pubmed.ncbi.nlm.nih.gov/34464022/Actively Recruiting
Led by Instituto Médico Tecnológico SL · Updated on 2025-05-23
90
Participants Needed
1
Research Sites
N/A
Total Duration
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
Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women
P
Paula Sanfeliu Rosell, MSc
I
Inés Ramírez García, PhD
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Instituto Médico Tecnológico SL
Lead Sponsor
RAPbarcelona
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Jean M Marino
https://pubmed.ncbi.nlm.nih.gov/34464022/Instituto Médico Tecnológico SL
Lead Sponsor
RAPbarcelona
Collaborating Sponsor