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| Name | Class |
|---|---|
| PHYSIOQUANTA | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postmenopausal patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation | Device | Six weekly photobiomodulation sessions (PBMT) using the MILTA ™ GYNECO vaginal probe. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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). | 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). | Week 4 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | Day 0 |
| Performance of the MILTA™ GYNECO vaginal probe on pain linked to vaginal atrophy |
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Inclusion Criteria:
Exclusion Criteria:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Mares | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nîmes | Nîmes | France | ||||
| Centre Médical KARIS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41404945 | Result | 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. |
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Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction). |
| 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). | Week 6 |
Visual analogue scale (0-10): the device will be considered effective if the VAS pain score decreases by at least 30% |
| Week 6 |
| Performance of the MILTA™ GYNECO vaginal on the vaginal mucosa | Vaginal Health Index: Score 1-5 | Day 0 |
| Performance of the MILTA™ GYNECO vaginal on the vaginal mucosa | Vaginal Health Index: Score 1-5 | Week 6 |
| Vaginal pH | pH value between 4 - 7.5 | Day 0 |
| Vaginal pH | pH value between 4 - 7.5 | 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 | 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 | 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) | Week 6 |
| Perpignan |
| France |
| Centre Hospitalier de Valenciennes | Valenciennes | 59322 | France |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D059268 | Atrophic Vaginitis |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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