NCT02739880
Completed
Not Applicable
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
Centre Hospitalier Universitaire de Nīmes2 sites in 1 country20 target enrollmentJune 19, 2017
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Menopause
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- The thickness of the vaginal mucosa on a histological section
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The thickness of the vaginal mucosa on a histological section
Time Frame: Week 8
Secondary Outcomes
- 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)
- Vaginal pH(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)
Study Sites (2)
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