Clinical trial NCT02739880: Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Dyspareunia
Keywords: Vaginal discomfort
Vaginal dryness
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Laboratoires Vivacy
First posted: 2016-04-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: The thickness of the vaginal mucosa on a histological section
timeFrame: Day 0
measure: The thickness of the vaginal mucosa on a histological section
timeFrame: Week 8
Secondary outcomes:
measure: Vaginal pH
timeFrame: Day 0
measure: Vaginal pH
timeFrame: Week 8
measure: Vaginal flora (on Pap smear)
timeFrame: Day 0
measure: Vaginal flora (on Pap smear)
timeFrame: Week 8
measure: Nugent score (on Pap smear)
timeFrame: Day 0
measure: Nugent score (on Pap smear)
timeFrame: Week 8
measure: PGI-I (Patient Global Impression and Improvement) Questionnaire
timeFrame: Week 8
measure: The Vaginal Health Index by Gloria Bachman
timeFrame: Day 0
measure: The Vaginal Health Index by Gloria Bachman
timeFrame: Week 8
measure: Pain (dyspareunia) by visual analog scale
timeFrame: Day 0
measure: Pain (dyspareunia) by visual analog scale
timeFrame: Week 8
measure: Measurement of collagen expression (procollagen I and III)
timeFrame: Day 0
measure: Measurement of collagen expression (procollagen I and III)
timeFrame: Week 8
measure: Level of Ki67 proliferation marker
timeFrame: Day 0
measure: Level of Ki67 proliferation marker
timeFrame: Week 8
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Perpignan
country: France
facility: Centre Médical KARIS
Study officials:
affiliation: Centre Médical Karis
name: Nicolas Berreni, MD
role: STUDY_DIRECTOR
References: