Evaluation of the Safety and Performance of the MILTA GYNECO Vaginal Probe in Postmenopausal Women With Vaginal Atrophy

NCT05058313 | Completed

• 1 other identifier: IDIL/2020/PM-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief 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%. 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

Keywords

post-menopausal period; low level light therapy; genitourinary

Outcome Measures

Primary Outcomes (7)

• 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

  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

Secondary Outcomes (9)

• Performance of the MILTA™ GYNECO vaginal probe on pain linked to vaginal atrophy

  Day 0

• Performance of the MILTA™ GYNECO vaginal probe on pain linked to vaginal atrophy

  Week 6

• Performance of the MILTA™ GYNECO vaginal on the vaginal mucosa

  Day 0

• Performance of the MILTA™ GYNECO vaginal on the vaginal mucosa

  Week 6

• Vaginal pH

  Day 0

Study Arms (1)

Postmenopausal patients

EXPERIMENTAL

Device: Photobiomodulation

Interventions

Photobiomodulation DEVICE

Six weekly photobiomodulation sessions (PBMT) using the MILTA ™ GYNECO vaginal probe.

Postmenopausal patients

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 under legal protection, under guardianship or under curatorship.
• Patient for whom it is impossible to give informed information.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• PHYSIOQUANTA: collaborator

Study Sites (3)

CHU Nîmes

Nîmes, France

Location

Centre Médical KARIS

Perpignan, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, 59322, France

Location

Related Publications (1)

• 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. 2025 Dec 17:1-7. doi: 10.1080/13697137.2025.2591279. Online ahead of print.

  PMID: 41404945 RESULT

MeSH Terms

Conditions

Urinary Incontinence; Atrophic Vaginitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Genital Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Pierre Mares

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 27, 2021
• Study Start: March 29, 2022
• Primary Completion: June 13, 2023
• Study Completion: May 6, 2024
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

FR (3)