Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Effect of Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule: A Prospective, Bicentric, Pilot Study

Conditions
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Menopause, Dyspareunia

Intervention / Treatment
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* Device: DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The study population<br>The study population consists of postmenopausal patients (more than 2 years and less than 10 years) with a body mass index <35 with sexual disorders (dyspareunia) or vaginal discomfort associated with vaginal dryness. Intervention: Intra-mucosal Injections of Cross-linked Hyaluronic Acid | Device: DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)<br>* 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.<br>* Other names: DESIRIAL®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The thickness of the vaginal mucosa on a histological section |  | Day 0 | 
| The thickness of the vaginal mucosa on a histological section |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal pH |  | Day 0 | 
| Vaginal pH |  | Week 8 | 
| Vaginal flora (on Pap smear) |  | Day 0 | 
| Vaginal flora (on Pap smear) |  | Week 8 | 
| Nugent score (on Pap smear) |  | Day 0 | 
| Nugent score (on Pap smear) |  | Week 8 | 
| PGI-I (Patient Global Impression and Improvement) Questionnaire |  | Week 8 | 
| The Vaginal Health Index by Gloria Bachman |  | Day 0 | 
| The Vaginal Health Index by Gloria Bachman |  | Week 8 | 
| Pain (dyspareunia) by visual analog scale |  | Day 0 | 
| Pain (dyspareunia) by visual analog scale |  | Week 8 | 
| Measurement of collagen expression (procollagen I and III) |  | Day 0 | 
| Measurement of collagen expression (procollagen I and III) |  | Week 8 | 
| Level of Ki67 proliferation marker |  | Day 0 | 
| Level of Ki67 proliferation marker |  | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal discomfort, Vaginal dryness