Sjögren's disease (SjD) is a chronic, immune-mediated, systemic inflammatory disease characterized mainly by involvement of the salivary and lacrimal glands, causing symptoms of sicca syndrome. The disease predominantly affects women (9:1 to 20:1), with a peak incidence between 40 and 60 years of age. Symptoms of dryness include those resulting from vaginitis sicca, such as vulvovaginal irritation, dryness, pruritus, dyspareunia, polyuria, nocturia, dysuria, and urinary urgency/incontinence, which may begin before and worsen after menopause. These symptoms impact the sexual life and health-related quality of life of SjD patients. However, there are no specific recommendations for the management of vaginal dryness in this disease. Urogenital syndrome (UGS), a condition that affects women from the general population in the menopausal phase, is characterized by similar symptoms and can be treated with systemic or local hormone therapy (e.g., topical promestriene). Current data also demonstrate the efficacy and safety of vaginal fractional CO2 laser treatment for UGS. However, there are no studies on the efficacy of vaginal fractional CO2 laser and topical promestriene in the treatment of vaginal dryness in SjD.
This is a prospective randomized study lasting 6 months. Sixty SjD patients (pre- or post-menopausal) and with complaints of vaginal dryness will be included and randomized into two groups: 30 patients for the intervention group - vaginal fractional CO2 laser - and 30 patients for the comparator group - topical promestriene. Vaginal fractional CO2 laser applications will be performed once a month for three consecutive months. Patients in the group treated with promestriene will apply a 10 mg vaginal capsule at night for fifteen consecutive days and, after this period, one application every three days, until completing six months of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Vaginal fractional CO2 laser applications will be performed once a month for three consecutive months.
Patients in the group treated with promestriene will apply a 10 mg vaginal capsule at night for fifteen consecutive days and, after this period, one application every three days, until completing six months of treatment.
Vaginal Health Index (VHI)
To assess the improvement in the Vaginal Health Index (VHI) after treatment compared to the patient's baseline status in both arms. This score ranges from 5 (minimum) to 25 (maximum) and higher values indicate better outcomes.
Time frame: Four and six months
6-Item version of the Female Sexual Function Index (FSFI)
To assess the improvement in the 6-item version of the Female Sexual Function Index (FSFI) after treatment compared to the patient's baseline status in both arms. This score ranges from 0 (minimum) to 30 (maximum) and higher values indicate better outcomes.
Time frame: Four and six months
Primary Sjögren's Syndrome Quality of Life questionnaire (PSSQoL)
To assess the improvement in the Primary Sjögren's Syndrome Quality of Life questionnaire (PSSQoL) after treatment compared to the patient's baseline status in both arms. This score ranges from 0 (minimum) to 96 (maximum) and higher values indicate worse outcomes.
Time frame: Four and six months
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
To assess the improvement in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) after treatment compared to the patient's baseline status in both arms. This score ranges from 0 (minimum) to 21 (maximum) and higher values indicate worse outcomes.
Time frame: Four and six months
Visual analogue scale (VAS) of vaginal dryness symptoms
To assess the improvement in the visual analogue scale (VAS) of vaginal dryness symptoms after treatment compared to the patient's baseline status in both arms. This scale ranges from 0 (minimum) to 10 (maximum) and higher values indicate worse outcomes.
Time frame: Four and six months
Persistence of the beneficial effects of laser therapy - visual analogue scale (VAS) of vaginal dryness symptoms
To assess the possible persistence of the beneficial effects of laser therapy after the end of applications (in the medium term). This assessment will be performed by observing improvements on the visual analogue scale (VAS) of vaginal dryness symptoms after treatment compared to the patient's baseline status in both arms. This scale ranges from 0 (minimum) to 10 (maximum) and higher values indicate worse outcomes.
Time frame: Six months
Incidence of treatment-emergent adverse events (safety and tolerability)
To assess the incidence of treatment-emergent adverse events (as a percentage) in the two arms of the study.
Time frame: One month, two months, three months, four months, five months, six months
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) (safety and tolerability)
To assess the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) after treatment compared to the patient's baseline status in both study arms. This score ranges from 0 (minimum) to 123 (maximum) and higher values indicate worse outcomes.
Time frame: Four and six months
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