Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule (INREG 1)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Dyspareunia; Menopause

Treatments: Device: DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02739880

2016-A00124-47 (Other Identifier)

LOCAL/2016/PM-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

The study population

Experimental group

Description:

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

Treatment:

Device: DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)