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

Menopause Clinical Trial

— INREG 1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739880
• Other study ID #: LOCAL/2016/PM-001
• Secondary ID: 2016-A00124-47
• Status: Completed
• Phase: N/A
• Start date: June 19, 2017
• Est. completion date: February 13, 2019

Study information

• Verified date: March 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 13, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspareunia
• Menopause

Intervention

Device:
• DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)
Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule The intervention is Intended for intra-mucosal injection in women for biostimulation / rehydration of the surface layers of the lining of the genital areas, vaginal hypotrophies and / or treatment of female sexual dysfunction related to subsidence G "spot or area of Gräfenberg ". Following disinfection and topical anesthesia (lidocaine gel), the vesitbule is injected using a multi-point technique. The optimal volume of DESIRIAL® to be used for injection into the vestibule is approximately 0.3 ml in total.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09
France	Centre Médical KARIS	Perpignan

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Laboratoires Vivacy

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The thickness of the vaginal mucosa on a histological section		Day 0
Primary	The thickness of the vaginal mucosa on a histological section		Week 8
Secondary	Vaginal pH		Day 0
Secondary	Vaginal pH		Week 8
Secondary	Vaginal flora (on Pap smear)		Day 0
Secondary	Vaginal flora (on Pap smear)		Week 8
Secondary	Nugent score (on Pap smear)		Day 0
Secondary	Nugent score (on Pap smear)		Week 8
Secondary	PGI-I (Patient Global Impression and Improvement) Questionnaire		Week 8
Secondary	The Vaginal Health Index by Gloria Bachman		Day 0
Secondary	The Vaginal Health Index by Gloria Bachman		Week 8
Secondary	Pain (dyspareunia) by visual analog scale		Day 0
Secondary	Pain (dyspareunia) by visual analog scale		Week 8
Secondary	Measurement of collagen expression (procollagen I and III)		Day 0
Secondary	Measurement of collagen expression (procollagen I and III)		Week 8
Secondary	Level of Ki67 proliferation marker		Day 0
Secondary	Level of Ki67 proliferation marker		Week 8