Atrophic Vaginitis
Conditions
Interventions
Randomization: 36 patients meeting the study inclusion criteria will receive a number according to their order of inclusion in the study which will correspond to one of the treatment groups. The assoc
Sponsors
Universidade Brasil
Cássia Caroline Garcia Dalbem Teles
Hospital Regional de Cáceres Dr. Antônio Fontes
Eligibility
Sex/Gender
Female
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: Physiologically postmenopausal women with amenorrhea longer than one year and plasma follicle-stimulating hormone dosage greater than 40 U/l and estradiol less than 25 pg/mL. Age between 50 and 70 years. Present clinical symptoms of the menopausal genitourinary syndrome. Current cervical cytological exam performed in the last six months negative for neoplasia
Exclusion criteria
Exclusion criteria: Women who have received any form of hormone replacement therapy in the past six months. Women who have used non-hormonal vaginal lubricants or moisturizers in the past month. Presence of active genital infections. Patients with a history of genital herpes who are unwilling to take oral Acyclovir prophylaxis. Women who have chronic inflammatory diseases that make the procedures unfeasible. Carriers of thrombophilia or regular users of anticoagulants or platelet antiaggregants. Patients that present vaginal prolapse of second or third degree according to the Pelvic Organ Prolapse Quantification System. Patients with a history of photosensitivity. Those who have had previous treatment with endovaginal CO2 laser or micro ablative Radiofrequency in any period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically and objectively assess urogenital health using the Vaginal Health Index (VHIS). The VHIS assesses the vaginal mucosa for its elasticity, pH, fluid volume, epithelial integrity, and mucosal lining. Each parameter is rated from 1 to 5, with a final score ranging from 5 to 25. If the total score is = 15, the vagina is considered atrophic. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess sexual function in women using the Female Sexual Function Index (FSFI) questionnaire. The FSFI is a brief, self-administered 19-item questionnaire that assesses female sexual response across six domains: sexual desire, sexual arousal, vaginal lubrication, orgasm, sexual satisfaction, and pain. Each question has a response pattern whose options receive scores from 0 to 5 in an increasing way in relation to the presence of the questioned function. Only in questions about pain the score is defined in an inverted way. The total score is the result of the sum of the scores for each domain multiplied by a factor that homogenizes the influence of each domain on the total score. Based on a cut-off point for the total score (defined as 26.55 for the instrument's original population), it would be possible to discriminate between populations with a higher and lower risk of having sexual dysfunction, with values ??equal to or below this point indicating dysfunction. sexual.;Evaluate the intensity of the genitourinary symptoms using the Visual Analog Scale from 0 to 10 cm for the intensity of symptoms dryness, burning, vaginal itching, dysuria and pain during sexual intercourse. The extreme left (0) will indicate absence of the symptom and the extreme right of the scale (10) will indicate the worst intensity experienced for that symptom in relation to the last 4 weeks. The measurement will be performed in centimetres.;Evaluate urinary symptoms using the International Consultation on Incontinence Questionnaire– Urinary Incontinence (ICIQ-UI) questionnaire. It is a validated tool for global assessment and widely accepted, used in studies of urinary incontinence. This questionnaire, based on 5 questions, assesses the reasons for UI, its incidence, frequency and impact on daily lifestyle.;Evaluate the histology of the vaginal mucosa. Verified from biopsies of the vaginal mucous region of 4 patients from each group drawn at random. The slides will be analyzed using hematoxy | — |
Countries
Brazil
Contacts
Public ContactCassia Teles
Universidade Brasil
Outcome results
None listed