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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Healthy Volunteers: No
View:

• 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.

Locations
Other Locations
France
CHU Nîmes
Recruiting
Nîmes
Centre Médical KARIS
Not yet recruiting
Perpignan
Contact Information
Primary
Pierre Mares
pierre.mares@chu-nimes.fr
04.66.68.42.76
Time Frame
Start Date: March 29, 2022
Estimated Completion Date: June 2023
Participants
Target number of participants: 25
Treatments
Experimental: Postmenopausal patients
Authors
Pierre Mares, Nicolas BERENI
Sponsors
Leads: Centre Hospitalier Universitaire de Nīmes
Collaborators: PHYSIOQUANTA

This content was sourced from clinicaltrials.gov

Similar Clinical Trials