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This is a randomized, controlled trial aiming to evaluate the effectiveness of adding vaginal dilators to the treatment of vulvovaginal atrophy.
Study Population:
Peri- and postmenopausal women with VVA, including breast cancer survivors.
Design: Monocentric pilot RCT evaluating SoC (MHT, lubricants, moisturizers) (control group) to SoC + vaginal dilators (test group).
Vaginal Dilator : A silicone medical device will be used for gradual stretching progression. The kit includes dilators of progressively larger sizes.
Procedures: Assessments at baseline, at 4 & 12 weeks
Measures : Vulvo Vaginal Atrophy severity , dyspareunia, Vaginal Health Index Score, Female Sexual Fonction Index, and Visual Analogue Scale (for vaginal dryness, vaginal and/or vulvar irritation/itching, and pain during sexual intercourse).
Statistical Analysis:
Differences at baseline, 4 weeks, and 12 weeks will be tested using:
Two-sample t-test Mann-Whitney test
Statistical Power:
Assuming a 20% improvement in Group 1 and 40% in Group 2, with:
p < 0.05 (type I error) 80% power (type II error), 160 patients needed across both groups.
SoC = Standard of care RCT = Randimized control trial MHT = Menopausal hormonal therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group : vaginal dilators | Experimental | A Test group receiving the standard treatment + a kit of vaginal dilators with progressively larger sizes. |
|
| Control Group : placebo | No Intervention | A control group receiving the standard treatment (which includes MHT, vaginal lubricants, and Moisturizers). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaginal dilators | Device | Evaluate the efficacy of vaginal dilators as an addition to Standard of Care in premenopausal or menopausal women, including breast cancer survivors |
|
| Measure | Description | Time Frame |
|---|---|---|
| • Vaginal dryness score |
| At baseline, 4 and 12 weeks |
| • Vaginal and/or vulvar irritation/itching |
| At baseline, 4 and 12 weeks |
| • Pain during sexual intercourse score |
| At baseline, 4 and 12 weeks |
| Vaginal Health index score | The vaginal health score (VHIS) consists of analyzing five vaginal parameters: Vaginal elasticity; Volume of vaginal secretions; vaginal pH; the integrity of the epithelium of the vaginal walls and the lubrication/hydration of the vagina. For each vaginal parameter we give a score ranging from 1 to 5 The VHIS score is obtained by adding all the scores obtained (minimum score = 5 and maximum score = 25. If VHIS <15, the vagina is considered atrophic. | at baseline and 12 weeks |
| Patient satisfaction : visual analogue scale |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | Did you experience any side effects or discomfort related to the procedure?
| At 4 and 12 weeks |
| Rate of adherence to the study by patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Piral, medical student | Contact | +33673428392 | julie.piral@ulb.be | |
| Aurélie Joris, gynaecologist | Contact | +32 2 535 34 86 | aurelie.joris@stpierre-bru.be |
| Name | Affiliation | Role |
|---|---|---|
| Serge Rozenberg, Gynaecologist | Saint Pierre University Hospital Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Pierre University Hospital Center | Recruiting | Brussels | Brussels Capital | 1000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23679050 | Background | Kingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013 Jul;10(7):1790-9. doi: 10.1111/jsm.12190. Epub 2013 May 16. |
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all collected IPD, all IPD that underlie results in a publication
October 2024 -2025 : 1 year
on request
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Monocentric pilot RCT evaluating SoC (MHT, lubricants, moisturizers) (control group) to SoC + vaginal dilators (test group).
SoC = Standard of care RCT = randomized control trial MHT = Menopausal hormonal therapy
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Evaluation of symptoms linked to vaginal atrophy (dryness, irritation, dyspareunia) on a visual analogue scale for pain (0 to 10) 0 = symptoms absent 10 = unbearable symptoms
| At baseline, 4 and 12 weeks |
| Quality of life questionnaire specific to genitourinary syndrome | Answer yes or no : Over the past week, have you been bothered by: Itchy vulva? Burning or tingling in the vulva? Pain in the vulva? Irritations to the vulva? Dryness in the vulva? Unpleasant vulvar or vaginal discharge? Odors coming from your vulva or vagina? Are you worried about your vulvar symptoms? (for example, will it spread, get worse, leave scars? etc.) Frustrations about your vulvar symptoms? Embarrassment about your vulvar symptoms? How do your vulvar symptoms affect your interactions with others? How do your vulvar symptoms affect your desire to be with people? Do your vulvar symptoms prevent you from showing affection? How do your vulvar symptoms affect your daily activities? Do your vulvar symptoms prevent you from having intimate relationships? The effects of your vulvar symptoms on your sexual relations? Do your vulvar symptoms cause pain during sexual activity? Do your vulvar symptoms cause dryness during sexual activity? | At baseline, 4 and 12 weeks |
| Female Sexual Function Index (FSFI) questionnaire |
Full Scale Score Range minimum score : 2.0 maximum score : 36.0 | At baseline, 4 and 12 weeks |
Was the intervention compatible with your lifestyle?
|
| At 4 and 12 weeks |
| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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