Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To study the efficacy and safety of intravaginal CO2 laser versus intravaginal Er:YAG laser and sham application in alleviating genitourinary symptoms in patients receiving an aromatase inhibitor as adjuvant treatment of breast cancer
The objective is to compare microablative fractional CO2 laser (CO2 laser) (SmartXide2 V2 LR, Monalisa Touch; DEKA, Florence, Italy) and non-ablative photothermal Erbium:YAG laser (Er:YAG laser) (Fotona Smooth™ XS; Fotona, Ljubljana, Slovenia) - with sham vaginal applications for treatment of vaginal dryness as the leading symptom in breast cancer patients with iatrogenic menopause and treated with an AI.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mona Lisa Touch CO2 laser | Active Comparator |
|
|
| Fotona Smooth erbium:YAG laser | Active Comparator |
|
|
| sham treatment | Sham Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravaginal laser | Device | application of intravaginal laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in severity dryness as most bothersome symptom (MBS) of GSM at 3 months after the end of treatment | scored on a 10 cm VAS | at 3 months after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported effect of laser on other GSM symptoms | scored on a 10 cm VAS | at 3 months after the end of treatment |
| Female Sexual Function Index (FSFI) | measured with FSFI questionnaire. The cut-off score of >26,55 will be used to discriminate between women with impaired and unimpaired sexual functioning |
Not provided
Inclusion Criteria:
Recruited participants will meet all of these criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susanne Housmans, MD | Contact | +3216332211 | susanne.housmans@uzleuven.be | |
| Jan Deprest, PhD | Contact | +3216332211 | jan.deprest@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Susanne Housmans, MD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | Flemish Brabant | 3000 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
3 parallel arms of equal size, participants can cross over after 3 initial treatments
Not provided
Not provided
participant and outcome assessor are blinded
| at 3 months after the end of treatment |
| Urinary Distress Index (UDI-6) | Measured with UDI-6 questionnaire | at 3 months after the end of treatment |
| The degree of discomfort of the treatment procedure by the participant | scored on a 10 cm VAS | at the end of the each treatment-visit |
| The longevity of the effect | Determined by questioning the need the participant feels for repeat treatment, and its nature (repeat laser or alternatives) until two years after the end of treatment. | at 24 months after the end of treatment |
| Vaginal pH | Measured with a pH indicator strip (range 3.6-6.1) and is sampled from the lateral vaginal wall in the lower third of the vagina | at 3 months after the end of treatment |
| Vaginal Health Index Score (VHIS) | Scoring of vaginal moisture, vaginal fluid volume, vaginal elasticity, vaginal pH, and vaginal epithelial integrity on a scale of 1 (poorest) to 5 (best) according to the methods of Robert Wood Johnson Medical School. The lower the score, the greater the atrophy. Vaginal moisture is an assessment of the appearance and spread or consistency of the secretions which coat the vagina. Vaginal elasticity is a measure of the ability of the vaginal tissue to stretch from the examiner's finger. Vaginal epithelial integrity takes into account color, thickness, and ability of the tissue to resist breaking secondary to touch. | at 3 months after the end of treatment |
| Vaginal Maturation Value (VMV) | A vaginal smear will be obtained from the lateral vaginal wall using a spatula and will be stained according to the Papanicolaou technique. The Vaginal Maturation Index (VMI) is evaluated by defining the proportion of superficial, intermediate, and parabasal epithelial cells on the smear. To combine this information into a single score for quantifying estrogenization, the VMV was calculated. It is based on weighted proportions of cell types from the VMI and calculated using Meisels' formula: the percentage of superficial cells (S) plus 0.5 times the percentage of intermediate cells (I) coded from the cytology sample [MV= %S + (0.5 × % I)](streamdown:incomplete-link) | at 3 months after the end of treatment |
| Description of adverse events | Adverse events are questioned at each visit following an intravaginal treatment. | until 1 month after the last treatment visit |
| D017437 |
| Skin and Connective Tissue Diseases |