vaginal atrophy
Conditions
Interventions
The group of 9 patients undergoing treatment with CO2 Laser received 3 laser sessions with 30 (+ or-5 days) intervals.
The group of 6 patients undergoing treatment with Thermocontrolled Radiofrequency
Sponsors
PONTÍFICE UNIVERSIDADE CATÓLICA DO PARANÁ
Liga de Combate ao Cancer do Hospital Erasto Gaertner
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women aged 1 year or more after finishing Radio / Chemotherapy for Breast Cancer; more than a year after spontaneous or medication menopause; no manifestations of active cancer or metastases; who have any symptoms of Vulvovaginal Atrophy (dryness, itching or burning sensation, pain or bleeding during intercourse, recurrent cystitis or dysuria).
Exclusion criteria
Exclusion criteria: Use of systemic or topical hormone replacement therapy in the last 12 months; acute urinary infection; recurrent active or viral genital infection (Herpes or HIV); vaginal prolapse> grade II; use of vaginal lubricants in the last 30 days; serious or psychiatric illnesses; use of psychotropic drugs; are using pacemakers, orthoses or prostheses in the case of patients undergoing Radiofrequency; do not be able to attend the clinic on the days previously determined.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical improvement of Vaginal Atrophy will be assessed by VAS, Visual Analogue Scale, which consists of an 11-point scale, where 0 is the lowest level (no symptoms) and 10 the highest (the worst possible), for 5 symptoms: burning vaginal, itching, dryness, pain during intercourse and pain when urinating.;Upon gynecological examination, the researcher will assess the VHIS, Vaginal Health Score Index, with assessment of elasticity, vaginal secretion, pH, epithelium and hydration. The score takes into account the sum of the items where 1 = worst assessment and 5 the best assessment, with score min = 5 and max = 25.;The cytological improvement of Vaginal Atrophy will be observed by the collection of hormonal cytology, with evaluation of the Frost Index and quantification of cells in the basal, intermediate and superficial layers.;The increase in the thickness of the vaginal mucosa will be seen by measuring the epithelium in material obtained by biopsies of the vaginal wall before and after intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| The improvement of urinary complaints will be assessed by the ICIQ-SF, International Consultation on Incontinence Questionaire- , where the final score is the sum of questions 3, 4 and 5. If the final score is greater than 8, it is considered to be of high impact, if less than 8 low impact.;The improvement in sexual function will be assessed by the FSFI, Female Sexual Function Index. The questionnaire contains 19 questions, subdivided into six (6) domains: desire, excitement, lubrication, orgasm, satisfaction and pain, where the minimum score is 2.0 (severe dysfunction) and the maximum is 36.0 (absence of dysfunction) .;The changes in the vaginal flora will be verified by vaginal secretion culture on Mac Conkey agar, blood agar and chocolate agar as well as by material obtained with slide collections for fresh examination.;At the end of the study, the Global Satisfaction Index, Likert Scale 5, to assess satisfaction in relation to the applied intervention. It consists of a scale of 1 to 5, where the lowest value is 1 (very satisfied) and the highest is 5 (very dissatisfied). | — |
Countries
Brazil
Contacts
Public ContactDULCE CRISTINA HENRIQUES
PONTÍFICE UNIVERSIDADE CATÓLICA DO PARANÁ
Outcome results
None listed