Clinical Trial: Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
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
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 Summary:
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.
Sponsor: Centre Hospitalier Universitaire de Nīmes
Current Primary Outcome:
- The thickness of the vaginal mucosa on a histological section [ Time Frame: Day 0 ]
- The thickness of the vaginal mucosa on a histological section [ Time Frame: Week 8 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Vaginal pH [ Time Frame: Day 0 ]
- Vaginal pH [ Time Frame: Week 8 ]
- Vaginal flora (on Pap smear) [ Time Frame: Day 0 ]
- Vaginal flora (on Pap smear) [ Time Frame: Week 8 ]
- Nugent score (on Pap smear) [ Time Frame: Day 0 ]
- Nugent score (on Pap smear) [ Time Frame: Week 8 ]
- PGI-I (Patient Global Impression and Improvement) Questionnaire [ Time Frame: Week 8 ]
- The Vaginal Health Index by Gloria Bachman [ Time Frame: Day 0 ]
- The Vaginal Health Index by Gloria Bachman [ Time Frame: Week 8 ]
- Pain (dyspareunia) by visual analog scale [ Time Frame: Day 0 ]
- Pain (dyspareunia) by visual analog scale [ Time Frame: Week 8 ]
- Measurement of collagen expression (procollagen I and III) [ Time Frame: Day 0 ]
- Measurement of collagen expression (procollagen I and III) [ Time Frame: Week 8 ]
- Level of Ki67 proliferation marker [ Time Frame: Day 0 ]
- Level of Ki67 proliferation marker [ Time Frame: Week 8 ]
Original Secondary Outcome: Same as current
Information By: Centre Hospitalier Universitaire de Nīmes
Dates:
Date Received: April 6, 2016
Date Started: July 2017
Date Completion: January 2018
Last Updated: September 19, 2016
Last Verified: September 2016