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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- The thickness of the vaginal mucosa on a histological section
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
The study population
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
干预措施: DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid) (Device)
结局指标
主要结局
The thickness of the vaginal mucosa on a histological section
时间窗: Week 8
次要结局
- 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)