on-invasive measurement of vaginal tissue hydration in women with and without GSM

Conditions: Genitourinary syndrome of menopause (GSM)
Vaginal atrophy
10074469

Registration Number: NL-OMON56226

Lead Sponsor: Bergman Clinics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the reproducibility of the Corneometer® as a<br /><br>measurement instrument to quantify hydration of the vaginal wall, evaluated by<br /><br>intra- and interobserver agreement. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are:<br /><br>1. Response to treatment for GSM using vaginal oestrogen, as measured with the<br /><br>Corneometer®.<br /><br>2. Differences in vaginal hydration measurements between women with and without<br /><br>GSM.<br /><br>3.Correlations between vaginal hydration measurements and:<br /><br>a. Objective measure of GSM: pH<br /><br>b. Subjective measure of GSM: most bothersome symptom approach (MBS)<br /><br>c. Subjective measure of improvement: Patient Global Impression of Improvement<br /><br>(PGI-I)</p><br>