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NCT Number: NCT05058313

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

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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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nîmes, Nîmes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 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.

Treatment and study plan

Photobiomodulation

Device

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

Secondary outcomes

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

    Time frame: Day 0

    Visual analogue scale (0-10): the device will be considered effective if the VAS pain score decreases by at least 30%

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

    Time frame: Week 6

    Visual analogue scale (0-10): the device will be considered effective if the VAS pain score decreases by at least 30%

  3. Performance of the MILTA™ GYNECO vaginal on the vaginal mucosa

    Time frame: Day 0

    Vaginal Health Index: Score 1-5

  4. Performance of the MILTA™ GYNECO vaginal on the vaginal mucosa

    Time frame: Week 6

    Vaginal Health Index: Score 1-5

  5. Vaginal pH

    Time frame: Day 0

    pH value between 4 - 7.5

  6. Vaginal pH

    Time frame: Week 6

    pH value between 4 - 7.5

  7. Vaginal flora

    Time frame: Day 0

    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

  8. Vaginal flora

    Time frame: Week 6

    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

  9. Patient satisfaction Patient satisfaction

    Time frame: Week 6

    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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • PHYSIOQUANTA

Registry information

Official study 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

Acronym: SIVAM

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 27, 2021
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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