Genitourinary Symptoms and Ill-Defined Conditions, Vulvovaginal Atrophy
Conditions
Keywords
genitourinary symptoms of menopause, CO2 fractional ablative laser, Early breast cancer, Vulvovaginal atrophy, Vaginal dryness, Dyspareunia, Vaginal itch, Dysuria
Brief summary
To determine the efficacy of ablative carbon dioxide laser in the treatment of the signs and symptoms of vulvovaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) in women with breast cancer.
Detailed description
LAAVA 2 is a double blinded randomised placebo/sham-controlled trial assessing whether fractional ablative carbon dioxide is beneficial in improving symptoms in women with a history of early breast cancer. Patients will be randomly assigned in a 1:1 ratio to either active laser treatment or inactive sham laser treatment (setting of close to zero) Participants will receive the 3 treatments approximately 4 weeks apart. Participants will then be followed up at twelve weeks post completion of treatment and twelve months post completion of treatment. At the twelve week follow up visit, after completion of study procedures, patients will be unblinded and those who received sham treatment will be allowed to crossover to active treatment if they wish.
Interventions
Vaginal / vulval laser treatment
DEVICEPlacebo
Sham Device
Sponsors
Royal North Shore Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with a history of early breast cancer \>18 years of age * At baseline patients must have at least one of five symptoms rated at ≥5 on a 10cm VAS scale. Symptoms include vulvo-vaginal itch, dryness, burning, dysuria and dyspareunia. * Three groups of patients will qualify: * Treatment induced premature menopause ≤45 years of age (eg secondary to chemotherapy or oophorectomy) for \>6 months * Premenopausal women on GNRH (gonadotrophin releasing hormone) agonist + tamoxifen or an aromatase inhibitor * Postmenopausal women on tamoxifen or an aromatase inhibitor * Willingness to give written informed consent and willingness to comply with the study * Up to date pap test / HPV (human papillomavirus) testing
Exclusion criteria
* Medical contraindication to the use of fractional ablative CO2 laser * Use of oestrogen therapies (systemic or local) in the 6 weeks prior to study treatment * Use of vaginal lubricants or moisturisers 14 days prior to the study treatment * Active or recent genitourinary infections (\<30 days) * Genital prolapse (grade III) * Active or symptomatic vulvo-vaginal dermatological conditions (Lichen sclerosus, lichen planus, vulval psoriasis, Chron's disease, Hidradenitis Suppurativa, vulval dermatitis, candida, chronic vulvovaginal candidiasis, vulval intraepithelial neoplasia, genital warts) * Inability to tolerate the use of fractional ablative CO2 laser (eg vaginismus)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal dryness | 12 weeks after completion of treatment | Improvement in vaginal dryness on a 10cm visual analog scale (VAS). A 10cm VAS is a scale from 0 to 10 with 0 being no symptoms and 10 being worst symptoms possible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other symptoms of vulvovaginal atrophy | 12 weeks after completion of treatment and 12 months after active treatment | Improvement in itch, burning, dysuria, dyspareunia and urinary incontinence of a 10cm visual analog scale (VAS) |
| Maturation index | 12 weeks after completion of treatment and 12 months after active treatment | Improvement in maturation index from a vaginal swab (a pathological test: the maturation index counts 200 cells and compares the ratio of parabasal:intermediate:superficial squamous cells. Oestrogen deficient smears will show fewer superficial cells and an increase in parabasals (implies an atrophic picture) ) |
| Vaginal pH | 12 weeks after completion of treatment and 12 months after active treatment | Improvement in vaginal pH |
| Clinician Assessed Changes | 12 weeks after completion of treatment and 12 months after active treatment | Improvement in vaginal moistness, colour and labia stickiness (moistness and stickiness assessed by a physician as present or not, colour as assessed on a predefined colour chart out of 4 colours). |
| Quality of Life (QOL) of patients assessed on the Vulval Quality of Life Index | 12 weeks after completion of treatment and 12 months after active treatment | Improvement in QOL assessed on the Vulval Quality of Life Index (VQLI) -a validated tool. The scoring bands of the VQLI includes: 0-5 = no effect on patient's life, 6-13 = small effect on patient's life, 14-23 = moderate effect on patient's life, 24-37 = very large effect on patient's life, 38-45 = extremely large effect on patient's life. |
| Sexual Function | 12 weeks after completion of treatment and 12 months after active treatment | Improvement in sexual function assessed on the Female Sexual Function Index (FSFI) - a validated tool |
| Satisfaction with treatment assessed on a Likert Scale | 12 weeks after completion of treatment and 12 months after active treatment | Patient satisfaction assessed on Likert Scale - a validated tool scoring from 1 to 5 (1=strongly disagree, 2=disagree, 3= neutral, 4=agree, 5=strongly agree) |
| Safety of laser treatment (Side effects) | 15 months | Side effects reported over the duration of the study will be collected descriptively |
Countries
Australia
Contacts
Primary ContactAntonia Pearson, BMed
Backup ContactEmily Forward, MBBS MBA BSc
Outcome results
None listed