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

NCT ID: NCT02739880

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-19
• Study Completion Date: 2018-09-06

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.

Conditions

Menopause; Dyspareunia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Cross-linked Hyaluronic Acid; DESIRIAL®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Laboratoires Vivacy

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Berreni, MD

Role: STUDY_DIRECTOR

Centre Médical Karis

Locations

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Centre Médical KARIS

Perpignan, , France

Countries

France

References

Berreni N, Salerno J, Chevalier T, Alonso S, Mares P. Evaluation of the effect of multipoint intra-mucosal vaginal injection of a specific cross-linked hyaluronic acid for vulvovaginal atrophy: a prospective bi-centric pilot study. BMC Womens Health. 2021 Aug 28;21(1):322. doi: 10.1186/s12905-021-01435-w.

Reference Type: RESULT

PMID: 34454465 (View on PubMed)

Other Identifiers

2016-A00124-47

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2016/PM-001

Identifier Type: -

Identifier Source: org_study_id