Clinical trial NCT03816735: Laser vs Hyaluronic Acid for GSM in Breast Cancer
Official title: Erbium:Yag Laser vs Hyaluronic Acid Suppository for GSM in Breast Cancer (BC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urogenital Disease
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized open study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: genitorurinary symptoms of menopause (GSM) determined by vaginal health index score
timeFrame: 3 months
Secondary outcomes:
measure: Symptoms severity- visual analogue scale
timeFrame: 3 months
measure: Treatment discomfort / pain; assessed by visual analogue scale
timeFrame: 3 months
measure: Patient Global Impression of Improvement
timeFrame: 3 months
measure: Patient Global Impression of Severity
timeFrame: 3 months
measure: Female Sexual health
timeFrame: 3 months
measure: pelvic floor symptoms
timeFrame: 3 months
measure: Patient satisfaction with treatment/ inpatient management
timeFrame: 3 months
measure: Discontinuation rate
timeFrame: 3 months
measure: Dyspareunia rate
timeFrame: 3 months
measure: Quality of life: EORTC quality of life questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Obstetrics, Medical University Graz
Study officials:
References:
citation: Gold D, Nicolay L, Avian A, Greimel E, Balic M, Pristauz-Telsnigg G, Tamussino K, Trutnovsky G. Vaginal laser therapy versus hyaluronic acid suppositories for women with symptoms of urogenital atrophy after treatment for breast cancer: A randomized controlled trial. Maturitas. 2023 Jan;167:1-7. doi: 10.1016/j.maturitas.2022.08.013. Epub 2022 Sep 9.
citation: European Urogynaecological Association 2021 Annual Meeting | Hybrid Edition. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):244-271. doi: 10.1097/SPV.0000000000001172. No abstract available.