Dyspareunia, Menopause
Conditions
Keywords
Vaginal discomfort, Vaginal dryness
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)
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.
Sponsors
Laboratoires Vivacy
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* The patient must have given her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 8 weeks of follow-up * The patient is menopausal (amenorrhea) for over 2 years and less than 10 years * The patient has a body mass index \<35 * The patient has sexual disorders (dyspareunia) or vaginal discomfort associated with vaginal dryness.
Exclusion criteria
* The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant or breastfeeding * The patient is not menopausal (both clinically and biologically) * The patient has a body mass index \> 35 * The patient has a genital prolapse higher than stage 2 with a surgical indication * The patient has stress incontinence with a surgical indication * The patient suffers from vaginismus * Presence of an untreated viral, fungal or bacterial vulvovaginal or urinary infection * Hemorrhagic or neoplastic genital pathologies * Existence of a hormone-dependent tumor, genital bleeding of unknown origin * Current treatments based on antihypertensives, steroid anti-inflammatory drugs, anticoagulants, major antidepressants, aspirin * Known hypersensitivity to hyaluronic acid or mannitol * Known hypersensitivity to Betadine * Known hypersensitivity to Lidocaine * Hypersensitivity to EMLA® * Previous urogynaecological vulvovaginal surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The thickness of the vaginal mucosa on a histological section | Day 0 |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal flora (on Pap smear) | Day 0 |
| Nugent score (on Pap smear) | Day 0 |
| PGI-I (Patient Global Impression and Improvement) Questionnaire | Week 8 |
| Vaginal pH | Day 0 |
| Pain (dyspareunia) by visual analog scale | Day 0 |
| Measurement of collagen expression (procollagen I and III) | Day 0 |
| Level of Ki67 proliferation marker | Day 0 |
| The Vaginal Health Index by Gloria Bachman | Day 0 |
Countries
France
Outcome results
None listed