MenopauseNCT06710002
Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women
A study testing Pelvify: Menopause and dyspareunia treatment, Face to Face Physical Therapy Protocol and Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program in people with Menopause and Genitourinary Syndrome of Menopause, run by Instituto Médico Tecnológico SL at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Menopause, Genitourinary Syndrome of Menopause, Dyspareunia
- What is being tested?
- Pelvify: Menopause and dyspareunia treatment, Face to Face Physical Therapy Protocol and Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 5 May 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age from 45 to 65 years.
- Menopausal
- Suffer dyspareunia for 3 months of evolution.
- Willing to complete study questionnaires and informed consent study.
Who cannot join
- 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.
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
RAPbarcelona
Barcelona, Spain, 08037
Inés Ramírez García, PhD, +34 677745765, iraga73@gmail.com
Paula Sanfeliu Rosell, MsC, +34 648222751, fisiopaulasanfeliu@gmail.com
About this study
Official title: Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women With Dyspareunia: Protocol of a Randomized Clinical Trial.
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.
Read the 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.
- Conditions
- Menopause, Genitourinary Syndrome of Menopause, Dyspareunia
- Being tested
- Pelvify: Menopause and dyspareunia treatment, Face to Face Physical Therapy Protocol, Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program
- Keywords
- Physiotherapy, Telerehabilitation, face to face treatment, female sexual function, vaginal dilators, manual therapy, capacitive resistive monopolar radiofrequency
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvify: Menopause and dyspareunia treatmentBehavioural
Topics addressed in the Asynchronous Online Telerehabilitation Program would be:
- What it is and why it hurts during sex. What is dyspareunia?
- How to recover vaginal elasticity.
- Massage
- Self-palpation.
- Stretching of the pelvic floor muscles.
- Use of vaginal dilators.
- Moisturizers and lubricants.
- Sexual pleasure.
- Communication with the partner.
Face to Face Physical Therapy ProtocolOther
Physical Therapy Protocol will be based on:
- Health education:
- CMRF: INDIBA® ACTIV CT8 will be used to apply the radiofrequency
- Manual therapy: it will be based on performing the Thiele's massage.
- Vaginal dilators: FEMINAFORM® vaginal dilators will be used.
Face to Face Protocol Combined With an Asynchronous Telerehabilitation ProgramOther
Both, the face to face protocol and the Asynchronous Telerehabilitation Program will be carried on on this group.
| Study group | Role | What they receive |
|---|---|---|
| Asynchronous Online Telerehabilitation Program | Experimental | 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. Receives: Behavioral: Pelvify: Menopause and dyspareunia treatment |
| Face to Face Physical Therapy Protocol | Active comparator | 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. Receives: Other: Face to Face Physical Therapy Protocol |
| Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program | Active comparator | 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. Receives: Other: Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Female Sexual Function via Female Sexual Function Index (FSFI)
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.
Measured: 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
Reduction in the Intensity of Dyspareunia Pain via Visual Analogue Scale (VAS)
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.
Measured: From enrollment to the end of treatment at 5 weeks, one week after treatment, and at six months and twelve months post treatment
Improved Quality of Life via Menopause Specific Quality of Life Questionnaire (MENQOL)
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.
Measured: 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
Secondary outcomes (1)
Change from the size of the Vaginal Dilator inserted without pain
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.
Measured: From enrollment to one week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start5 May 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Médico Tecnológico SL
- Sponsor type
- University, hospital or other
- Collaborators
- RAPbarcelona
- Responsible party
- Principal investigator, Inés Ramírez García, University Ramon Llull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710002
- Sponsor's protocol ID
- RAPbarcelonaPAULA
- Status last verified
- May 2025
- First submitted
- 18 Nov 2024
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marino JM. Genitourinary Syndrome of Menopause. J Midwifery Womens Health. 2021 Nov;66(6):729-739. doi: 10.1111/jmwh.13277. Epub 2021 Aug 31.
PubMed 34464022
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women With Dyspareunia: Protocol of a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06710002
- Acronym / sponsor ID
- RAPbarcelonaPAULA
- Conditions
- Menopause, Genitourinary Syndrome of Menopause, Dyspareunia
- Keywords
- Physiotherapy, Telerehabilitation, face to face treatment, female sexual function, vaginal dilators, manual therapy, capacitive resistive monopolar radiofrequency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Instituto Médico Tecnológico SLUniversity, hospital or other
- Collaborators
- RAPbarcelona
- Study start
- 5 May 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asynchronous Online Telerehabilitation Program | Experimental | Behavioral: Pelvify: Menopause and dyspareunia treatmentFor 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. |
| Face to Face Physical Therapy Protocol | Active comparator | Other: Face to Face Physical Therapy ProtocolThis 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. |
| Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program | Active comparator | Other: Face to Face Protocol Combined With an Asynchronous Telerehabilitation ProgramThis 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Age from 45 to 65 years.
- Menopausal
- Suffer dyspareunia for 3 months of evolution.
- Willing to complete study questionnaires and informed consent study.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvify: Menopause and dyspareunia treatmentTopics 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. | Behavioural | Asynchronous Online Telerehabilitation Program |
| Face to Face Physical Therapy ProtocolPhysical 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. | Other | Face to Face Physical Therapy Protocol |
| Face to Face Protocol Combined With an Asynchronous Telerehabilitation ProgramBoth, the face to face protocol and the Asynchronous Telerehabilitation Program will be carried on on this group. | Other | Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program |
Primary outcome
Improved Female Sexual Function via Female Sexual Function Index (FSFI)
Time frame: 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)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Change from the size of the Vaginal Dilator inserted without pain
Time frame: From enrollment to one week after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 34464022Marino JM. Genitourinary Syndrome of Menopause. J Midwifery Womens Health. 2021 Nov;66(6):729-739. doi: 10.1111/jmwh.13277. Epub 2021 Aug 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvify: Menopause and dyspareunia treatment, Face to Face Physical Therapy Protocol and Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program in people with Menopause and Genitourinary Syndrome of Menopause, run by Instituto Médico Tecnológico SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paula Sanfeliu Rosell, MSc (+34 648222751, fisiopaulasanfeliu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved Female Sexual Function via Female Sexual Function Index (FSFI) (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06710002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.