Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule
- Conditions
- DyspareuniaMenopause
- Interventions
- Device: DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)
- Registration Number
- NCT02739880
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description The study population DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid) 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
- Primary Outcome Measures
Name Time Method The thickness of the vaginal mucosa on a histological section Week 8
- Secondary Outcome Measures
Name Time Method Level of Ki67 proliferation marker Week 8 Nugent score (on Pap smear) Week 8 Measurement of collagen expression (procollagen I and III) Week 8 Pain (dyspareunia) by visual analog scale Week 8 PGI-I (Patient Global Impression and Improvement) Questionnaire Week 8 Vaginal flora (on Pap smear) Week 8 The Vaginal Health Index by Gloria Bachman Week 8 Vaginal pH Week 8
Trial Locations
- Locations (2)
Centre Médical KARIS
🇫🇷Perpignan, France
CHRU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France