Clinical trial NCT05058313: Evaluation of the Safety and Performance of the MILTA GYNECO Vaginal Probe in Postmenopausal Women With Vaginal Atrophy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Urinary Incontinence
Atrophic Vaginitis
Keywords: post-menopausal period
low level light therapy
genitourinary
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: PHYSIOQUANTA
First posted: 2021-09-27
Enrollment: 25
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
timeFrame: Day 1
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
timeFrame: Week 1
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
timeFrame: Week 2
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
timeFrame: Week 3
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
timeFrame: Week 4
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
timeFrame: Week 5
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
timeFrame: Week 6
Secondary outcomes:
measure: Performance of the MILTA™ GYNECO vaginal probe on pain linked to vaginal atrophy
timeFrame: Day 0
measure: Performance of the MILTA™ GYNECO vaginal probe on pain linked to vaginal atrophy
timeFrame: Week 6
measure: Performance of the MILTA™ GYNECO vaginal on the vaginal mucosa
timeFrame: Day 0
measure: Performance of the MILTA™ GYNECO vaginal on the vaginal mucosa
timeFrame: Week 6
measure: Vaginal pH
timeFrame: Day 0
measure: Vaginal pH
timeFrame: Week 6
measure: Vaginal flora
timeFrame: Day 0
measure: Vaginal flora
timeFrame: Week 6
measure: Patient satisfaction Patient satisfaction
timeFrame: Week 6
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nîmes
city: Perpignan
country: France
facility: Centre Médical KARIS
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Pierre Mares
role: PRINCIPAL_INVESTIGATOR
References: