VAginal Health – What’s Normal? The VAN Study
Research type
Research Study
Full title
A prospective observational feasibility study to evaluate the best diagnostic tool for urogenital atrophy, to assess the extent of the condition and response to treatment
IRAS ID
288402
Contact name
Dharani Hapangama
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
3 years, 0 months, 2 days
Research summary
Lack of the hormone oestrogen, can affect the health and function of the vagina and bladder causing a condition called urogential atrophy (UGA), which is common around the menopause (in up to 80% of women). There is currently no reproducible way to assess or diagnose this condition to treat and to assess if treatment is effective.
This study aims to evaluate the agreement and acceptability of 5 different methods that can be used for the assessment of possible UGA with the current standard clinical diagnostic assessment before and after various commonly used, recommended treatment interventions.
Total of 60 women, presenting with symptoms of UGA will be recruited and we will ask them to undergo the following 5 additional procedures; (1) wear a vaginal tampon for 20 mins and return it to assess the molecular biomarkers; (2) complete a short questionnaire assessing acceptability of all 5 tests and symptoms; As part of routine examination these women will undergo a speculum exam, and during this procedure the clinician will (3) objectively record the findings (elasticity and tissue quality) according to a standardised, colour coded tape; (4) apply a colour changing pH paper to vaginal secretions to record the acidity and (5) take a smear of the vaginal walls, for evaluating the heath of the vaginal mucosa. All patients with a diagnosis of UGA will be offered treatment according to usual clinical pathway and when they return for their routine review after 4 months, the 5 procedures mentioned above will be repeated.
Primary outcome: Compare the feasibility, acceptability and agreement of five different modalities with the current standard, the clinical diagnosis of urogenital atrophy by a physician, to assess symptomatic patients.
Secondary outcome: The feasibility of using these different methods to assess the outcomes of various treatments currently routinely used for UGA.REC name
Wales REC 7
REC reference
21/WA/0026
Date of REC Opinion
29 Jan 2021
REC opinion
Favourable Opinion