NCT03816735

Laser vs Hyaluronic Acid for GSM in Breast Cancer

Erbium:Yag Laser vs Hyaluronic Acid Suppository for GSM in Breast Cancer (BC)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

All women from the outpatient department with a history of BC and GSM (genitourinary symptoms of menopause) symptoms will be invited to participate. After informed consent patients are either randomized to intravaginal laser or hyaluronic acid suppository treatment intravaginally, respectively. Laser treatment will be performed twice, at baseline and after 1 month. The intravaginal hyaluronic acid suppository therapy will be applied daily during the first 10 days and then every third day until the three months follow-up. At baseline and three months follow-up the following questionnaires will be filled out (VAS, (PGI-I, PGI-S, Female Sexual health questionnaire (EORTC), Baessler questionnaire, EORTC quality of life questionnaire, ZUF-8).

Detailed description

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.

Conditions

• Urogenital Disease

Interventions

Type	Name	Description
DEVICE	Cikatridina	Women are asked to insert the suppositories according to the manufacturer's protocol.
DEVICE	Juliet Feminine Laser	Women will receive the laser treatment twice during the study period.

Timeline

• Start date: 2019-01-24
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2019-01-25
• Last updated: 2024-01-18

Locations

1 site across 1 country: Austria