Breast Cancer, Dyspareunia, Genitourinary Syndrome of Menopause, Vaginal Atrophy
Conditions
Brief summary
This study evaluates the efficacy of vaginal CO2 laser therapy in breast cancer survivors with symptoms of Genitourinary Syndrome of Menopause. Half of participants will receive active laser therapy, while the other half placebo therapy.
Interventions
5 laser therapies intravaginally administered will be applied at monthly intervals.
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* breast cancer history * dyspareunia * dryness
Exclusion criteria
* Active genital infection (i.e herpes, vaginitis) * Prolapse stage \>=2 * Underlying pathologies that could interfere with the protocol compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness | Change from baseline at 1 month post-treatment | It is a straight line with 2 endpoints 0 and 10. Zero defines no dyspareunia at all and no dryness at all , while 10 dyspareunia as bad as it could be and dryness as bad as it could be. Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of dyspareunia and dryness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Day-to Day Impact of vaginal aging questionnaire (DIVA) | Change from baseline at 1 month post-treatment | It includes 4 domains: activities of daily living (5 items), sexual functioning (5 items), emotional well-being (4 items), self-concept and body image (5-items). Each item of each domain could receive values from 0 to 4. Mean scores are calculated on each of the domain scales. Higher scores indicate greater symptom impact |
| Patients Global Impression of Improvement | At 1-month post-treatment | It is a single item questionnaire assessing the impression of participants following the intervention |
| 10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria | Change from baseline at 1 month post-treatment | It is a straight line with 2 endpoints 0 and 10. Zero defines no symptom (itching, burning and dysuria) at all , while 10 symptom (itching, burning and dysuria) as bad as it could be. Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of itching, burning and dysuria |
| King's Health Questionnaire (KHQ) | Change from baseline at 1 month post-treatment | It has 3 sections: 1) general health and overall health related to urinary symptoms with 2 questions, 2) incontinence impact, role limitations, physical limitations, social limitations, personal limitations, emotions, sleep and energy, and severity coping measures with 19 questions and 3) bother or impact of urinary symptoms with 11 questions. Scores of each domain of the 2 sections range from 0 to 100. Scores of the third section range from 0 to 3. Higher scores indicate higher impact of urinary incontinence. |
| International Consultation on Incontinence Questionnaire Short Form | 6 months | it is a questionnaire with 4 questions assessing the amount of leakage, frequency and type of urinary incontinence. Total score is calculated by summing the 3 out of the 4 questions. Higher scores indicate worst urinary incontinence |
| Female Sexual Function Index | Change from baseline at 1 month post-treatment | It is a questionnaire defining women's sexual function. It includes 6 domains: desire, arousal, orgasm, lubrication, satisfaction and pain. The answer of each Question in each domain are multiplied by a certain factor. Total score is calculated by summing the scores of the all domains with a minimum value of 2 and a maximum of 36. The highest the total score the better is the sexual functioning. Total score above 26.55 defines normal sexual function |
| Vaginal Maturation Value | 6 months | It is calculated by defining the percentage of superficial, intermediate and parabasal epithelial cells on the vaginal pap smear, following the formula (1x%superficial)+(0.5x%intermediate)+(0x%parabasal). It may receive values from 0 to 100%.It is considered to be an indicator of the estrogenic stimulation, whereas values of 0-49%, 50-64% and 65-100% indicate absent/low, moderate and high estrogenic effect on the vaginal epithelium, respectively. |
| 3 days voiding diary | Change from baseline at 1 month post-treatment | Assesses frequency of urination, amount of urine, presence of urgency and/or urinary incontinence and amount of fluid intake |
| Modified Sexual Quality of Life Questionnaire-Male | 6 months | It includes 12 questions assessing the quality of life and sexual satisfaction of the male partner. Each answer may receive values from 1 to 5. The higher the scores the better subjective evaluation of sexual quality of life |
| Urogenital Distress Inventory 6 | 6 months | It is a condition specific questionnaire containing 6 questions. The answers of questions assesses the presence of symptoms and the degree of bother on a 4-point scale (not at all, a little bit, moderately and greatly applying to 0, 1, 2 and 3, respectively). Total score is calculated by summing the score of each question. The higher the total score the highest is the symptom bother |
| Epithelial thickness | 6 months | Biopsies will be obtained from the lateral vaginal wall. Epithelial thickness (in μ) will be measured by a vertical line between basal layer cells and superficial layers. |
| Number of blood vessels | 6 months | Biopsies will be obtained from the lateral vaginal wall. Computerized determination of blood vessels number will be performed |
| Size of blood vessels | 6 months | Biopsies will be obtained from the lateral vaginal wall. Computerized determination of the blood vessels size will be performed |
| Collagen | 6 months | Biopsies will be obtained from the lateral vaginal wall. Determination of collagen types using immunohistochemistry and microscopy. |
| Vaginal Health Index Score | 6 months | It evaluates vaginal elasticity, fluid volume, ph of vaginal fluid, epithelial integrity and moisture. Each one of these may receive scores from 1 to 5. Total score is calculated by summing the 5 scores ranging from 5 to 25. Higher scores indicate better vaginal status. |
Countries
Greece
Contacts
Primary ContactStavros Athanasiou, Associate Professor
Backup ContactAthanasios Douskos, MD
Outcome results
None listed