Laser vs Hyaluronic Acid for GSM in Breast Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    50
  • sponsor
    Medical University of Graz
Updated on 22 April 2022
Accepts healthy volunteers

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).

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.

Details
Condition Urogenital Disease
Treatment Cikatridina, Juliet Feminine Laser
Clinical Study IdentifierNCT03816735
SponsorMedical University of Graz
Last Modified on22 April 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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