MenopauseSIVAMNCT05058313
Evaluation of the Safety and Performance of the MILTA GYNECO Vaginal Probe in Postmenopausal Women With Vaginal Atrophy
A study testing Photobiomodulation in people with Menopause and Urinary Incontinence, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
Vulvovaginal atrophy is common after menopause, with a significant negative effect on quality of life. Large cohort studies have reported the prevalence of vaginal dryness to be between 27% and 55% and dyspareunia between 32% and 41%. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Menopause, Urinary Incontinence, Atrophic Vaginitis
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Mar 2022to 6 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with pelvic discomfort/pain (pain, dryness, irritation, etc.) due to vaginal atrophy that has failed all non-invasive therapies for over 3 months.
- Postmenopausal patient recruited during a consultation in the Gynecology department of the University Hospital of Nîmes or at the KARIS Medical Center in Perpignan and having undergone a complete clinical examination allowing any physical and / or psychological cause to be eliminated.
- Patient who has given her free and informed consent.
- Patient affiliated or beneficiary of a health insurance plan.
Who cannot join
- Patient not available for the 6-week follow-up.
- Patient presenting with pelvic pain of physical and / or psychological origin.
- Patients undergoing initial treatment for cancer and/or who have completed their treatments within the last year
- Patient with immunosuppression.
- Allergy to the material of the probe protection used (latex for example).
- Pregnancy.
Show all 12Show fewer
- Implantable device active in the heart such as a defibrillator or a pacemaker, neuromodulation stimulator, electrodes implanted for the treatment of Parkinson's disease.
- Epilepsy, photophobia, recent intake of photosensitizing drugs or cosmetics (in the last 6 months), history of porphyria.
- Patient participating in category 1 interventional study.
- Patient in an exclusion period determined by another study.
- Patient under legal protection, under guardianship or under curatorship.
- Patient for whom it is impossible to give informed information.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Nîmes
Nîmes
Centre Médical KARIS
Perpignan
Centre Hospitalier de Valenciennes
Valenciennes, 59322
About this study
Official title: Evaluation of the Safety and Performance of the MILTA GYNECO Vaginal Probe in Postmenopausal Women With Vaginal Atrophy Resistant to All Non-invasive Therapies for More Than 3 Months - Pilot Study of First Use in Females
Vulvovaginal atrophy is common after menopause, with a significant negative effect on quality of life. Large cohort studies have reported the prevalence of vaginal dryness to be between 27% and 55% and dyspareunia between 32% and 41%. Management of urogenital atrophy includes lifestyle modification, nonhormonal treatments (vaginal lubricants or moisturizers, laser treatments), as well as hormonal treatments. The disadvantages of the non-surgical methods are average results, discontinuation, and frequent contraindications to hormonal treatments.This has led to a strong interest in the development of non-invasive or minimally invasive methods that are easy to implement, effective and durable.
Photobiomodulation therapy (PBMT) has been proposed as an alternative for the treatment of genitourinary menopausal syndrome (GMS) and stress urinary incontinence. PBMT devices exert their effect via non-thermal mechanisms. PBMT stimulates collagen and elastin synthesis in the vaginal tissue, to support the urethrovaginal sphincter and urethra, and to promote vasodilation in the vaginal and urethral submucosa. PHYSIOQUANTA has developed a vaginal probe coupled with its innovative MILTA™ process synergistically combining NPCL (Nano-Pulsed Cold Laser) laser emitters, infrared diodes and RGB (Red Green Blue) diodes, operating in a magnetic tunnel. The MILTA acts deeper than LEDs, due to the diffusion of photons in soft tissues.
In this study, the study investigators aimed to evaluate the safety and performance of the MILTA™ GYNECO vaginal probe in a pilot study of first use in women. This clinical study on the MILTA vaginal probe is expected to result in its CE marking Class IIb DM.
- Conditions
- Menopause, Urinary Incontinence, Atrophic Vaginitis
- Being tested
- Photobiomodulation
- Keywords
- post-menopausal period, low level light therapy, genitourinary
- Medical subject headings
- Urinary Incontinence, Atrophic Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Six weekly photobiomodulation sessions (PBMT) using the MILTA ™ GYNECO vaginal probe.
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal patients | Experimental | Not described Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Measured: Day 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Measured: Week 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Measured: Week 2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Measured: Week 3
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Measured: Week 4
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Measured: Week 5
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Measured: Week 6
Secondary outcomes (9)
Performance of the MILTA™ GYNECO vaginal probe on pain linked to vaginal atrophy
Visual analogue scale (0-10): the device will be considered effective if the VAS pain score decreases by at least 30%
Measured: Day 0
Performance of the MILTA™ GYNECO vaginal probe on pain linked to vaginal atrophy
Visual analogue scale (0-10): the device will be considered effective if the VAS pain score decreases by at least 30%
Measured: Week 6
Performance of the MILTA™ GYNECO vaginal on the vaginal mucosa
Vaginal Health Index: Score 1-5
Measured: Day 0
Performance of the MILTA™ GYNECO vaginal on the vaginal mucosa
Vaginal Health Index: Score 1-5
Measured: Week 6
Vaginal pH
pH value between 4 - 7.5
Measured: Day 0
Vaginal pH
pH value between 4 - 7.5
Measured: Week 6
Vaginal flora
Nugent score: score from 0 to 10: 0 to 3: normal flora predominantly lactobacilli, 4 to 6: intermediate flora with scant lactobacilli and associated with other poorly differentiated bacterial morphotypes in small quantities, 7 to 10: suggestive of bacterial vaginosis
Measured: Day 0
Vaginal flora
Nugent score: score from 0 to 10: 0 to 3: normal flora predominantly lactobacilli, 4 to 6: intermediate flora with scant lactobacilli and associated with other poorly differentiated bacterial morphotypes in small quantities, 7 to 10: suggestive of bacterial vaginosis
Measured: Week 6
Patient satisfaction Patient satisfaction
Patient Global Impression of Change (PGI-C): Patients will be classified into 3 categories according to their score: deterioration (score of 1 to 3), stable (score of 4), improvement (score of 5 to 7)
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start29 Mar 2022
- Primary completion13 Jun 2023
- Study completion6 May 2024
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.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- PHYSIOQUANTA
- Responsible party
- Sponsor
- Investigators
- Pierre Mares, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058313
- Sponsor's protocol ID
- IDIL/2020/PM-001
- Acronym
- SIVAM
- Status last verified
- Dec 2025
- First submitted
- 27 Aug 2021
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salerno J, Serrand C, Kabani S, Chevallier T, de Tayrac R, Mares P. Safety and performance of photobiomodulation delivered by vaginal probe in patients with genitourinary syndrome of menopause. Climacteric. 2026 Apr;29(2):293-299. doi: 10.1080/13697137.2025.2591279. Epub 2025 Dec 17.
PubMed 41404945
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of the MILTA GYNECO Vaginal Probe in Postmenopausal Women With Vaginal Atrophy Resistant to All Non-invasive Therapies for More Than 3 Months - Pilot Study of First Use in Females
- ClinicalTrials.gov ID
- NCT05058313
- Acronym / sponsor ID
- SIVAM / IDIL/2020/PM-001
- Conditions
- Menopause, Urinary Incontinence, Atrophic Vaginitis
- Keywords
- post-menopausal period, low level light therapy, genitourinary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- PHYSIOQUANTA
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 27 Sep 2021 (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.
Vulvovaginal atrophy is common after menopause, with a significant negative effect on quality of life. Large cohort studies have reported the prevalence of vaginal dryness to be between 27% and 55% and dyspareunia between 32% and 41%. Management of urogenital atrophy includes lifestyle modification, nonhormonal treatments (vaginal lubricants or moisturizers, laser treatments), as well as hormonal treatments. The disadvantages of the non-surgical methods are average results, discontinuation, and frequent contraindications to hormonal treatments.This has led to a strong interest in the development of non-invasive or minimally invasive methods that are easy to implement, effective and durable.
Photobiomodulation therapy (PBMT) has been proposed as an alternative for the treatment of genitourinary menopausal syndrome (GMS) and stress urinary incontinence. PBMT devices exert their effect via non-thermal mechanisms. PBMT stimulates collagen and elastin synthesis in the vaginal tissue, to support the urethrovaginal sphincter and urethra, and to promote vasodilation in the vaginal and urethral submucosa. PHYSIOQUANTA has developed a vaginal probe coupled with its innovative MILTA™ process synergistically combining NPCL (Nano-Pulsed Cold Laser) laser emitters, infrared diodes and RGB (Red Green Blue) diodes, operating in a magnetic tunnel. The MILTA acts deeper than LEDs, due to the diffusion of photons in soft tissues.
In this study, the study investigators aimed to evaluate the safety and performance of the MILTA™ GYNECO vaginal probe in a pilot study of first use in women. This clinical study on the MILTA vaginal probe is expected to result in its CE marking Class IIb DM.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal patients | Experimental | Device: Photobiomodulation |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with pelvic discomfort/pain (pain, dryness, irritation, etc.) due to vaginal atrophy that has failed all non-invasive therapies for over 3 months.
- Postmenopausal patient recruited during a consultation in the Gynecology department of the University Hospital of Nîmes or at the KARIS Medical Center in Perpignan and having undergone a complete clinical examination allowing any physical and / or psychological cause to be eliminated.
- Patient who has given her free and informed consent.
- Patient affiliated or beneficiary of a health insurance plan.
Key exclusion criteria (12 listed)
- Patient not available for the 6-week follow-up.
- Patient presenting with pelvic pain of physical and / or psychological origin.
- Pregnancy.
- Implantable device active in the heart such as a defibrillator or a pacemaker, neuromodulation stimulator, electrodes implanted for the treatment of Parkinson's disease.
- Epilepsy, photophobia, recent intake of photosensitizing drugs or cosmetics (in the last 6 months), history of porphyria.
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 |
|---|---|---|
| PhotobiomodulationSix weekly photobiomodulation sessions (PBMT) using the MILTA ™ GYNECO vaginal probe. | Device | Postmenopausal patients |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Time frame: Day 1
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Time frame: Week 1
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Time frame: Week 2
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Time frame: Week 3
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Time frame: Week 4
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Time frame: Week 5
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Time frame: Week 6
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
9 secondary outcomes
Performance of the MILTA™ GYNECO vaginal probe on pain linked to vaginal atrophy
Time frame: Day 0
Performance of the MILTA™ GYNECO vaginal probe on pain linked to vaginal atrophy
Time frame: Week 6
Performance of the MILTA™ GYNECO vaginal on the vaginal mucosa
Time frame: Day 0
Performance of the MILTA™ GYNECO vaginal on the vaginal mucosa
Time frame: Week 6
Vaginal pH
Time frame: Day 0
Vaginal pH
Time frame: Week 6
Vaginal flora
Time frame: Day 0
Vaginal flora
Time frame: Week 6
Patient satisfaction Patient satisfaction
Time frame: Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Results publication: PubMed 41404945Salerno J, Serrand C, Kabani S, Chevallier T, de Tayrac R, Mares P. Safety and performance of photobiomodulation delivered by vaginal probe in patients with genitourinary syndrome of menopause. Climacteric. 2026 Apr;29(2):293-299. doi: 10.1080/13697137.2025.2591279. Epub 2025 Dec 17.
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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. This study is not recruiting at the moment.
Pierre Mares principal investigator
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Menopause and Urinary Incontinence, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe (time frame: Day 1). The study lists 7 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 NCT05058313, 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 31 Dec 2025.