The primary objective is to evaluate the reproducibility of the Corneometer® as a measurement instrument to quantify hydration of the vaginal wall, evaluated by intra- and interobserver variability. The secondary objective is to measure the response…
ID
Source
Brief title
Condition
- Menopause related conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the reproducibility of the Corneometer® as a
measurement instrument to quantify hydration of the vaginal wall, evaluated by
intra- and interobserver agreement.
Secondary outcome
Secondary study parameters are:
1. Response to treatment for GSM using vaginal oestrogen, as measured with the
Corneometer®.
2. Differences in vaginal hydration measurements between women with and without
GSM.
3.Correlations between vaginal hydration measurements and:
a. Objective measure of GSM: pH
b. Subjective measure of GSM: most bothersome symptom approach (MBS)
c. Subjective measure of improvement: Patient Global Impression of Improvement
(PGI-I)
Background summary
Genitourinary syndrome of menopause (GSM) is a chronic, progressive
vulvovaginal, sexual and lower urinary tract condition that affects one in two
postmenopausal women. GSM is characterized by signs and symptoms that can be
attributed to the lack of oestrogen inherent with menopause. The hypoestrogenic
state results in hormonal and anatomical changes in the genitourinary tract,
with vaginal dryness, dyspareunia, and reduced lubrication being the most
prevalent and bothersome symptoms. These symptoms often have a great impact on
daily activity, sexual function and overall quality of life.
Treatment for GSM aims to restore vaginal integrity and relieve urogenital
symptoms. Conservative treatment for GSM includes the use of non-hormonal
vaginal lubricants and moisturizers. For more severe or persistent symptoms of
GSM, standard medical treatment is vaginal oestrogen therapy, in the form of a
vaginal cream, ovules, tablets or a ring. Vaginal laser therapy is a novel,
alternative treatment modality for GSM.
The diagnosis and evaluation of GSM are clinical and mostly established through
a thorough anamnesis and physical pelvic examination. Objective measures that
evaluate GSM include vaginal pH and vaginal cytology (vaginal maturation index
(VMI), vaginal maturation value (VMV), karyopyknotic index (KI)). However,
cytology requires time and expertise and the relationship between these
measures and clinical outcome is poor.
Treatment strategies for GSM aim to increase vaginal epithelial thickness and
hydration. Objective evaluation of treatment effects should therefore evaluate
these outcome measures. Vaginal epithelial thickness can be evaluated
non-invasively by the focal depth using incident dark field imaging. For the
assessment of hydration, however, there are no non-invasive methods available
yet.
The Corneometer® (Courage + Khazaka, Köln, Germany), is a handheld lightweight
probe that is widely applied for objective assessment of hydration of the outer
layer of the epidermis (stratum corneum). Its main applications today are in
the field of cosmetology for efficacy testing of cosmetics and skincare
products. Corneometry has not been applied to the vaginal epithelium yet.
In this project, we will evaluate vaginal hydration as measured with the
Corneometer®. We will study the effect of GSM and vaginal oestrogen therapy on
vaginal hydration and evaluate intra- and interobserver variability.
Study objective
The primary objective is to evaluate the reproducibility of the Corneometer® as
a measurement instrument to quantify hydration of the vaginal wall, evaluated
by intra- and interobserver variability. The secondary objective is to measure
the response to treatment for GSM with vaginal oestrogens using the
Corneometer® and to relate changes in hydration to changes in yet validated
outcome measurements.
Study design
The proposed research concerns an observational validation study.
Study burden and risks
Enrolled participants receive standard medical care and do not require
additional visits. The technology for measuring hydration is non-invasive.
Measurements will be performed during routine physical examination, which is
all standard care. Measurements take less than 30 seconds, are painless and
cause no harm. No additional risks are expected.
Nijenburg 152
Amsterdam 1081GG
NL
Nijenburg 152
Amsterdam 1081GG
NL
Listed location countries
Age
Inclusion criteria
Group 1: women with GSM
- Age: >55 years old
- Starting standard medical treatment with vaginal oestrogen
- Presence of GSM will be determined by (1) the most bothersome symptom
approach (MBS: vaginal dryness, vaginal/vulvar irritation/itching,
vaginal/vulvar soreness, and dyspareunia), (2) physical examination (vaginal
physical examination scale (Greenadle et al. (1999)), (3) vaginal pH of 6.0 or
higher.
Group 2: women without GSM
- Age: 20 - 45 years old
- Reason for attending clinic: benign gynaecological conditions
Exclusion criteria
Group 1: women with GSM
1. Prior (trans)vaginal surgery
2. (History of) oncological or pre-oncological gynaecological disease
3. Already started treatment with vaginal oestrogen
Group 2: non-GSM group
1. Signs or symptoms of GSM
2. Currently using vaginal oestrogen treatment
3. Prior (trans)vaginal surgery
4. (History of) oncological or pre-oncological gynaecological disease
5. The following vaginal conditions: lichen planus, symptomatic candidiasis,
bacterial vaginosis.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL77856.100.21 |