Breast Cancer Clinical Trial
Official title:
Laser Treatment of Genito-urinary Syndrome in Women With Breast and Endometrial Cancer and Menopausal Women
Women with genitourinary syndrome of menopause, overactive bladder, with breast or endometrial cancer are randomized to either laser treatment og sham treatment for 3 months. The randomization is stratified for estrogen treatment. The effect is evaluated by questionnaire, histology and microbiology swaps
Status | Not yet recruiting |
Enrollment | 160 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - menopause i.e. age more than 50 years and absence of menstruation for twelve months - breast cancer - endometrial cancer - symptoms of vaginal dryness - dyspareunia rated as moderate or severe most bothersome symptoms Exclusion Criteria: - use of vaginal moisturizers, lubricants or any other local preparation within the thirty days prior to inclusion - acute or recurrent urinary tract infections - active genital infections i.e. herpes genitalis, candida - previous reconstructive pelvic surgery - pelvis organ prolapse stage 2 - any serious disease or chronic condition that could interfere with study compliance except from breast and endometrial cancer - psychiatric disorders precluding informed consent |
Country | Name | City | State |
---|---|---|---|
Denmark | Gynecology Dept. Herning Hospital | Herning |
Lead Sponsor | Collaborator |
---|---|
Herning Hospital |
Denmark,
Athanasiou S, Pitsouni E, Antonopoulou S, Zacharakis D, Salvatore S, Falagas ME, Grigoriadis T. The effect of microablative fractional CO2 laser on vaginal flora of postmenopausal women. Climacteric. 2016 Oct;19(5):512-8. doi: 10.1080/13697137.2016.1212006. Epub 2016 Aug 24. — View Citation
Salvatore S, Leone Roberti Maggiore U, Athanasiou S, Origoni M, Candiani M, Calligaro A, Zerbinati N. Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause. 2015 Aug;22(8):845-9. doi: 10.1097/GME.0000000000000401. — View Citation
Salvatore S, Nappi RE, Parma M, Chionna R, Lagona F, Zerbinati N, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. Sexual function after fractional microablative CO2 laser in women with vulvovaginal atrophy. Climacteric. 2015 Apr;18(2):219-25. doi: 10.3109/13697137.2014.975197. Epub 2014 Dec 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual analogue score on vaginal symptoms | 10-cm VAS to measure the overall satisfaction with vaginal symptoms, where the left extreme of the scale indicated ' the worst level of satisfaction ' and the right indicated ' the best level of satisfaction | three months | |
Secondary | histopathology | Qualitative analysis of the microscopic and ultrastructural aspects of the collagenic and elastic components of the matrix is performed. A specific image analysis with computerized morphometry is performed to demonstrate the specific action of CO2 laser and possibly to correlate the modifications of the ultrastructural pattern with specific molecular modifications. We also consider the fine cytological aspects of connective tissue proper cells, particularly fibroblasts, under the conditions of the specific laser stimulation. | three months | |
Secondary | microbiology | a sterile swab is inserted into the vaginal canal and a sample obtained from the posterior fornix of the vagina. Vaginal samples are placed in a transport gel (Stuart). pH indicator strips (MColorpHastTM, Merck, Germany) are applied against the lateral vaginal wall using sterile forceps, followed by a vaginal lavage for wet mount. Smears from vaginal samples are placed on a glass slide, observed under microscope for Trichomonas vaginalis and Candida species and stained afterwards according to standard Gram stain procedure. Cultures for aerobic and anaerobic bacteria species are performed, using MacConkey agar, blood agar, Sabouraud dextrose agar, chocolate agar as culture media, focusing on bacteria with potential clinical impact (e.g. aerobic vaginitis39, UTIs, vaginal candidiasis). | three months |
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