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

What this trial studies

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.

Conditions in scope

• Menopause
• Urinary Incontinence
• Atrophic Vaginitis

Interventions

• Photobiomodulation (Device) — Six weekly photobiomodulation sessions (PBMT) using the MILTA ™ GYNECO vaginal probe.

Who can join

Women only · Adults (Child, Adult, Older Adult)

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2022-03-29
• Primary completion: 2023-06-13
• Last update posted: 2025-12-31
• First posted: 2021-09-27

Sponsor & contact

Lead sponsor: Centre Hospitalier Universitaire de Nīmes (Other)

Collaborators: PHYSIOQUANTA

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe (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 (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 (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 (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 (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).

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.