The main objective of this study is to measure changes in the thickness of the vaginal lining (epithelium + underlying stroma) between 0 and 8 weeks after injection.
The secondary objectives of this study are to measure changes in the following between 0 and 8 weeks after injection: A. vaginal flora and Nugent score. B. vaginal pH. C. functional evolution via the VHI index by Gloria Bachman (state of the vaginal mucosa), pain / dyspareunia (visual analog scale) and the satisfaction concerning care viay the PGI-I questionnaire (Patient Global Impression and Improvement). D. Procollagen I and III gene expression (by PCR) and mitotic activity of the mucosa (Ki67 proliferation marker) based on biopsies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule The intervention is Intended for intra-mucosal injection in women for biostimulation / rehydration of the surface layers of the lining of the genital areas, vaginal hypotrophies and / or treatment of female sexual dysfunction related to subsidence G "spot or area of Gräfenberg ". Following disinfection and topical anesthesia (lidocaine gel), the vesitbule is injected using a multi-point technique. The optimal volume of DESIRIAL® to be used for injection into the vestibule is approximately 0.3 ml in total.
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
Centre Médical KARIS
Perpignan, France
The thickness of the vaginal mucosa on a histological section
Time frame: Day 0
The thickness of the vaginal mucosa on a histological section
Time frame: Week 8
Vaginal pH
Time frame: Day 0
Vaginal pH
Time frame: Week 8
Vaginal flora (on Pap smear)
Time frame: Day 0
Vaginal flora (on Pap smear)
Time frame: Week 8
Nugent score (on Pap smear)
Time frame: Day 0
Nugent score (on Pap smear)
Time frame: Week 8
PGI-I (Patient Global Impression and Improvement) Questionnaire
Time frame: Week 8
The Vaginal Health Index by Gloria Bachman
Time frame: Day 0
The Vaginal Health Index by Gloria Bachman
Time frame: Week 8
Pain (dyspareunia) by visual analog scale
Time frame: Day 0
Pain (dyspareunia) by visual analog scale
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Time frame: Week 8
Measurement of collagen expression (procollagen I and III)
Time frame: Day 0
Measurement of collagen expression (procollagen I and III)
Time frame: Week 8
Level of Ki67 proliferation marker
Time frame: Day 0
Level of Ki67 proliferation marker
Time frame: Week 8