Genitourinary Syndrome of Menopause
Conditions
Keywords
genitourinary syndrome of menopause, intravaginal laser, breast cancer, aromatase inhibitor
Brief summary
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
Detailed description
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.
Interventions
DEVICEintravaginal laser
application of intravaginal laser
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
participant and outcome assessor are blinded
Intervention model description
3 parallel arms of equal size, participants can cross over after 3 initial treatments
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Recruited participants will meet all of these criteria: * a history of breast cancer * premenopausal at diagnosis of breast cancer * using AI as an adjuvant treatment * moderate to severe symptoms of GSM (VAS ≥ 4/10) * currently menopausal, which can be either biochemical menopause as confirmed after chemotherapy, surgical or medicinally induced (GnRH analogues for the duration of the trial)
Exclusion criteria
* Not willing to abstain from vaginal intercourse for 1 week following laser therapy * Use of non-hormonal vaginal preparations within the last 6 weeks before inclusion * Use of hormonal therapy within 6 months prior to inclusion (systemic or local) * Acute urinary or genital tract infections * A history of genital fistula, a thin rectovaginal septum as determined by the investigator, or history of fourth degree laceration * Prolapse ≥ grade 2 according to the Pelvic Organ Prolapse Quantification System * Previous vaginal mesh implantation * Abnormal result in the last cervical smear (maximum 36 month before enrollment) * Active cancer treatment (radiotherapy or chemotherapy) ongoing or planned prior to the measurement of the primary outcome (6 months after inclusion, 3 months after last laser) * Vaginal stenosis that does not allow the placement of the laser probe * Any condition that could interfere with study compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in severity dryness as most bothersome symptom (MBS) of GSM at 3 months after the end of treatment | at 3 months after the end of treatment | scored on a 10 cm VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function Index (FSFI) | at 3 months after the end of treatment | measured with FSFI questionnaire. The cut-off score of \>26,55 will be used to discriminate between women with impaired and unimpaired sexual functioning |
| Urinary Distress Index (UDI-6) | at 3 months after the end of treatment | Measured with UDI-6 questionnaire |
| The degree of discomfort of the treatment procedure by the participant | at the end of the each treatment-visit | scored on a 10 cm VAS |
| The longevity of the effect | at 24 months after the end of treatment | 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. |
| Patient reported effect of laser on other GSM symptoms | at 3 months after the end of treatment | scored on a 10 cm VAS |
| Vaginal Health Index Score (VHIS) | at 3 months after the end of treatment | 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. |
| Vaginal Maturation Value (VMV) | at 3 months after the end of treatment | 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) |
| Description of adverse events | until 1 month after the last treatment visit | Adverse events are questioned at each visit following an intravaginal treatment. |
| Vaginal pH | at 3 months after the end of treatment | 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 |
Countries
Belgium
Contacts
Primary ContactSusanne Housmans, MD
Backup ContactJan Deprest, PhD
Outcome results
None listed