Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

All Conditions

Dyspareunia

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Diseases, Male

Sexual Dysfunction, Physiological

Male Urogenital Diseases

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Microablative Fractional CO2 Laser Therapy (The parameters that will be used are the following: 1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.)

Placebo therapy (The parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.

5 laser therapies intravaginally administered will be applied at monthly intervals.

Microablative Fractional CO2 Laser Therapy

Stavros Athanasiou, Associate Professor

Eleni Pitsouni, MD, MSc

Stavros Athanasiou, Associate professor

Themos Grigoriadis, Assistant Professor

Stavros Athanasiou, Prof.

Themos Grigoriadis, Assist. Prof.

Eleni Pitsouni, MD,MSc

Stavros Athanasiou, Associate Proffesor

Women with a history of pelvic radiotherapy due to gynecological cancer, will receive laser therapy for the management of genitourinary syndrome of menopause.

Laser Therapy Following Radiotherapy for Gynecological Cancer

The Efficacy of Intravaginal Laser Therapy in Women With History of Gynecological Cancer Treated With Pelvic Radiotherapy: Double-blind Randomized Placebo-controlled Trial

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

Assesses frequency of urination, amount of urine, presence of urgency and/or urinary incontinence and amount of fluid intake

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

It includes 4 functional scales (body image, sexual activity, sexual enjoyment, sexual/vaginal functioning) with 9 items and 5 symptoms scales (symptoms experience, lymphedema, peripheral neuropathy, menopausal symptoms and sexual worry) with 15 items. Each item range from 1 to 4. Higher scores in sexual activity and sexual enjoyment indicate better functioning, while higher scores in all other domains indicate higher impact of cervical cancer

It is a single item questionnaire assessing the impression of participants following the intervention

It is a 12-items questionnaire evaluating nocturia, urgency, bladder pain, frequency, hesitancy, straining, intermittency, urinary incontinence (urge, stress and unexplained), frequency of urinary incontinence and nocturnal enuresis. Filling, voiding and incontinence symptoms subscales range from 0 to 15, 0 to 12 and 0 to 20, respectively.

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.

It includes 6 domains assessing sexual functioning (desire, arousal, orgasm, lubrication, satisfaction and pain). Total score is calculated by summing scores of the 5 domains multiplied by certain factors with a minimum value of 2 and maximum 36

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.

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.

It evaluates aspects of sexual satisfaction of cancer survivors partners

National and Kapodistrian University of Athens

MD, PhD, Assistant Professor

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Syndrome

Breast Diseases

Skin Diseases

Menopause

All Drugs and Chemicals

Central Nervous System Depressants

Estrogens, Conjugated (USP)

Anesthetics

Estrogens

During our study, women will undergo treatment intravaginally and vulvar with the fractional microablative CO2 laser system (SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy). A treatment cycle includes three laser applications (every 40-50 days, approximately 6 weeks). The procedure will be performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia).

The women in the vaginal estrogen group will be prescribed and asked to administer: Conjugated estrogen cream (Premarin®): 0.5 g of cream intravaginally daily (using applicator or fingertip) for two weeks (fourteen days) then 0.5 g twice weekly for 24 ± 2 additional weeks.

Microablative Fractional CO2 Vaginal Laser Therapy

The purpose of this study is to assess the efficacy of a fractional CO2 laser ("SmartXide2 - V2LR", DEKA M.E.L.A., Florence - Italy) "the Laser" in the treatment of genitourinary symptoms of menopause, female sexual function, and urogenital health in comparison to vaginal estrogen. Only breast cancer patients who have HR (-) breast cancer are planning to be included in the vaginal estrogen group.

The investigators aim to determine the efficacy of the MonaLisaTouch Laser in comparison with vaginal estrogen in the management and treatment of GSM symptoms resulting in vaginal atrophy, sexual dysfunction and a decreased quality of life in women with a history of breast cancer. Patients will be stratified according to menopausal status prior to breast cancer therapy and HR tumor status. Fractional CO2 laser therapy has been approved by Health Canada for use in menopausal women with GSM, nevertheless long term efficacy and safety data is lacking in the breast cancer survivor population. In the short term (i.e. 6 month follow up), research has shown that this therapy is a safe and effective treatment that has promising benefits with little to no reported adverse events.

MonaLisa Laser Intervention for Post-Menopausal Breast Cancer Patients: A SHE CAN Study

Randomized Clinical Trial Comparing the MonaLisa Laser Versus Vaginal Estrogen in Post-Menopausal Breast Cancer Patients: a SHE CAN Non-inferiority Study

The aim of our research, is to assess the impact of the MonaLisa Touch Laser on the sexual health and quality of life of breast cancer survivors with GSM in comparison to vaginal estrogen.

To compare subjective improvement of vaginal dryness in breast cancer survivors, using the 10 cm visual analog scale (VAS) for GSM symptoms 6 months post-treatment between groups.

Mount Sinai Hospital, Canada

Principal Investigator

Atrophy

Athanasios Douskos, MD

Themos Grigoriadis, Assistant Proffesor

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.

Vaginal Laser Therapy in Breast Cancer Survivors

Vaginal Laser Therapy for the Management of Genitourinary Syndrome of Menopause of Breast Cancer Survivors: Double-blind Randomized Placebo-controlled Trial

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

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

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

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

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

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.

Biopsies will be obtained from the lateral vaginal wall. Computerized determination of blood vessels number will be performed

Biopsies will be obtained from the lateral vaginal wall. Computerized determination of the blood vessels size will be performed

Biopsies will be obtained from the lateral vaginal wall. Determination of collagen types using immunohistochemistry and microscopy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Laser Therapy Following Radiotherapy for Gynecological Cancer	NCT03714581	Pelvic Radiothe... Gynecological C... Dyspareunia Vaginal Dryness	Microablative F...	-	National and Kapodistrian University of Athens
MonaLisa Laser Intervention for Post-Menopausal Breast Cancer Patients: A SHE CAN Study	NCT04606550	Breast Cancer F... Genitourinary S...	Microablative F...	18 Years - 75 Years	Mount Sinai Hospital, Canada
Laser Therapy Following Radiotherapy for Gynecological Cancer	NCT03714581	Pelvic Radiothe... Gynecological C... Dyspareunia Vaginal Dryness	Microablative F...	-	National and Kapodistrian University of Athens
Vaginal Laser Therapy in Breast Cancer Survivors	NCT03738605	Genitourinary S... Vaginal Atrophy Breast Cancer Dyspareunia	Microablative F...	-	National and Kapodistrian University of Athens
MonaLisa Laser Intervention for Post-Menopausal Breast Cancer Patients: A SHE CAN Study	NCT04606550	Breast Cancer F... Genitourinary S...	Microablative F...	18 Years - 75 Years	Mount Sinai Hospital, Canada
Laser Therapy Following Radiotherapy for Gynecological Cancer	NCT03714581	Pelvic Radiothe... Gynecological C... Dyspareunia Vaginal Dryness	Microablative F...	-	National and Kapodistrian University of Athens
Laser Therapy Following Radiotherapy for Gynecological Cancer	NCT03714581	Pelvic Radiothe... Gynecological C... Dyspareunia Vaginal Dryness	Microablative F...	-	National and Kapodistrian University of Athens

Spots Global Cancer Trial Database for microablative fractional co2 laser therapy