Laser vs Hyaluronic Acid for GSM in Breast Cancer
Raktažodžiai
Santrauka
apibūdinimas
Device I- Laser The laser device is the Juliet feminine laser to treat women with SUI (Stress Urinary Incontinence), GSM and vaginal laxity. Asclepion' s headquarters are located in "Asclepion Laser Technologies GmbH - Brüsseler Str. 10 - 07747 Jena - Germany".
Device II- Suppository The second device is a vaginal suppository called "Cikatridina" manufactured by the company Angelini to treat women with GSM. Angelini Pharma Österreich GmbH's headquarters are located in Brigittenauer Lände 50-54, 1200 Wien, Austria.
Datos
Paskutinį kartą patikrinta: | 06/30/2020 |
Pirmasis pateikimas: | 01/22/2019 |
Numatytas registravimas pateiktas: | 01/23/2019 |
Pirmas paskelbtas: | 01/24/2019 |
Paskutinis atnaujinimas pateiktas: | 07/07/2020 |
Paskutinis atnaujinimas paskelbtas: | 07/08/2020 |
Faktinė studijų pradžios data: | 01/23/2019 |
Numatoma pirminio užbaigimo data: | 12/30/2021 |
Numatoma studijų užbaigimo data: | 12/30/2021 |
Būklė ar liga
Intervencija / gydymas
Device: hyaluronic acid suppository therapy
Device: Juliet feminine laser
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Active Comparator: hyaluronic acid suppository therapy Women receive a vaginal suppository called "Cikatridina" manufactured by the company Angelini to treat women with GSM. Angelini Pharma Österreich GmbH's headquarters are located in Brigittenauer Lände 50-54, 1200 Wien, Austria. The suppositories contain ontain hyaluronic acid, tea tree oil, tigergras extract, and aloe vera. | Device: hyaluronic acid suppository therapy Women are asked to insert the suppositories according to the manufacturer's protocol. |
Active Comparator: Juliet feminine laser The fractional microablative laser with 2940 nm wavelength has a high degree of absorption in water and selectively stimulates the synthesis of sub-mucosal collagen. The erbium-doped yttrium-aluminum-garnet (Er:YAG) laser has been successfully used in the field of plastic skin rejuvenation and reconstruction. The procedure is based on photothermic treatment of connective tissue: It has been established in animal and human studies that it affects collagen remodeling resulting in tightening of the supportive tissue. | Device: Juliet feminine laser Women will receive the laser treatment twice during the study period. |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 18 Years Į 18 Years |
Tinkamos studijoms lytys | Female |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion criteria - genital symptoms of dryness/ burning/ irritation - and/ or lack of lubrication during sexual intercourse/ sexual discomfort or pain - and/or symptoms of urgency and dysuria or recurrent urinary tract infection - Age 18-80 - History of BC and/ or DCIS - Completed locoregional therapy - Current antihormonal therapy for BC possible - Intravaginal treatment with creams/ suppositories other than study medicationshould be ceased during the trial Exclusion criteria: - Current or past genitourinary malignancy - Abnormal PAP smear - Current genitourinary tract infection - Abnormal uterine bleeding - photosensitive medication |
Rezultatas
Pirminės rezultatų priemonės
1. genitorurinary symptoms of menopause (GSM) determined by vaginal health index score [3 months]
Antrinės rezultatų priemonės
1. Symptoms severity- visual analogue scale [3 months]
2. Treatment discomfort / pain; assessed by visual analogue scale [3 months]
3. Patient Global Impression of Improvement [3 months]
4. Patient Global Impression of Severity [3 months]
5. Female Sexual health [3 months]
6. pelvic floor symptoms [3 months]
7. Patient satisfaction with treatment/ inpatient management [3 months]
8. Discontinuation rate [3 months]
9. Dyspareunia rate [3 months]
10. Quality of life: EORTC quality of life questionnaire [3 months]