Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule (INREG 1)

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

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.

Study Overview

• Status: Completed
• Conditions: Menopause; Dyspareunia
• Intervention / Treatment: Device: DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau
  • Perpignan, France, 66000
    • Centre Médical KARIS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

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.; Other Names: Cross-linked Hyaluronic Acid; DESIRIAL®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The thickness of the vaginal mucosa on a histological section	Day 0
The thickness of the vaginal mucosa on a histological section	Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Vaginal pH	Day 0
Vaginal pH	Week 8
Vaginal flora (on Pap smear)	Day 0
Vaginal flora (on Pap smear)	Week 8
Nugent score (on Pap smear)	Day 0
Nugent score (on Pap smear)	Week 8
PGI-I (Patient Global Impression and Improvement) Questionnaire	Week 8
The Vaginal Health Index by Gloria Bachman	Day 0
The Vaginal Health Index by Gloria Bachman	Week 8
Pain (dyspareunia) by visual analog scale	Day 0
Pain (dyspareunia) by visual analog scale	Week 8
Measurement of collagen expression (procollagen I and III)	Day 0
Measurement of collagen expression (procollagen I and III)	Week 8
Level of Ki67 proliferation marker	Day 0
Level of Ki67 proliferation marker	Week 8

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: Laboratoires Vivacy
• Investigators: Study Director: Nicolas Berreni, MD, Centre Médical KARIS

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): February 13, 2019
• Study Completion (Actual): February 13, 2019

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Vaginal dryness; Vaginal discomfort
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Dyspareunia; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: LOCAL/2016/PM-001; 2016-A00124-47 (Other Identifier: RCB number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No