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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed
CT.gov ID
NCT02739880
Collaborator
Laboratoires Vivacy (Industry)
20
Enrollment
2
Locations
1
Arm
19.8
Actual Duration (Months)
10
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)
 N/A

Detailed Description

The secondary objectives of this study are to measure changes in the following between 0 and 8 weeks after injection:

  1. vaginal flora and Nugent score.

  2. vaginal pH.

  3. 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).

  4. Procollagen I and III gene expression (by PCR) and mitotic activity of the mucosa (Ki67 proliferation marker) based on biopsies.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 19, 2017
Actual Primary Completion Date :
Feb 13, 2019
Actual Study Completion Date :
Feb 13, 2019

Arms and Interventions

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®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The thickness of the vaginal mucosa on a histological section [Day 0]

    2. The thickness of the vaginal mucosa on a histological section [Week 8]

    Secondary Outcome Measures

    1. Vaginal pH [Day 0]

    2. Vaginal pH [Week 8]

    3. Vaginal flora (on Pap smear) [Day 0]

    4. Vaginal flora (on Pap smear) [Week 8]

    5. Nugent score (on Pap smear) [Day 0]

    6. Nugent score (on Pap smear) [Week 8]

    7. PGI-I (Patient Global Impression and Improvement) Questionnaire [Week 8]

    8. The Vaginal Health Index by Gloria Bachman [Day 0]

    9. The Vaginal Health Index by Gloria Bachman [Week 8]

    10. Pain (dyspareunia) by visual analog scale [Day 0]

    11. Pain (dyspareunia) by visual analog scale [Week 8]

    12. Measurement of collagen expression (procollagen I and III) [Day 0]

    13. Measurement of collagen expression (procollagen I and III) [Week 8]

    14. Level of Ki67 proliferation marker [Day 0]

    15. Level of Ki67 proliferation marker [Week 8]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 69 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 09 France 30029
    2 Centre Médical KARIS Perpignan France 66000

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Nīmes
    • Laboratoires Vivacy

    Investigators

    • Study Director: Nicolas Berreni, MD, Centre Médical Karis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Nīmes
    ClinicalTrials.gov Identifier:
    NCT02739880
    Other Study ID Numbers:
    • LOCAL/2016/PM-001
    • 2016-A00124-47
    First Posted:
    Apr 15, 2016
    Last Update Posted:
    Mar 20, 2019
    Last Verified:
    Mar 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Nīmes
    Vaginal discomfort
    Vaginal dryness
    Additional relevant MeSH terms:
    Dyspareunia
    Hyaluronic Acid

    Study Results

    No Results Posted as of Mar 20, 2019