Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors

NCT05713435 | Recruiting

• 1 other identifier: S66520
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

To study the efficacy and safety of intravaginal CO2 laser versus intravaginal Er:YAG laser and sham application in alleviating genitourinary symptoms in patients receiving an aromatase inhibitor as adjuvant treatment of breast cancer

Conditions

Genitourinary Syndrome of Menopause

Keywords

genitourinary syndrome of menopause; intravaginal laser; breast cancer; aromatase inhibitor

Outcome Measures

Primary Outcomes (1)

• change in severity dryness as most bothersome symptom (MBS) of GSM at 3 months after the end of treatment

  scored on a 10 cm VAS

  at 3 months after the end of treatment

Secondary Outcomes (9)

• Patient reported effect of laser on other GSM symptoms

  at 3 months after the end of treatment

• Female Sexual Function Index (FSFI)

  at 3 months after the end of treatment

• Urinary Distress Index (UDI-6)

  at 3 months after the end of treatment

• The degree of discomfort of the treatment procedure by the participant

  at the end of the each treatment-visit

• The longevity of the effect

  at 24 months after the end of treatment

Study Arms (3)

Mona Lisa Touch CO2 laser

ACTIVE COMPARATOR

1. Power: 30 W. 2. Dwell time: 1000 μs. 3. Spacing: 1000 μm. 4. Depth: SmartStack parameter from 1 to 3 depending on the treatment status. 5. D-pulse mode. 6. At the introitus the power will be reduced to 24 W

Device: intravaginal laser

Fotona Smooth erbium:YAG laser

ACTIVE COMPARATOR

1. Phase I (vaginal) Renovalase™ mode with (a) fluence of 5,5J/cm2, (b) SMOOTHTM mode frequency 1.6 Hz, and (c) spot size 7 mm. 2. Phase II (vestibulum and introitus) Renovalase™ mode with (a) fluence 10 J/cm2, (b) SMOOTHTM mode frequency 1.6Hz, and (c) spot size 7 mm.

Device: intravaginal laser

sham treatment

SHAM COMPARATOR

1. The blocking device is inserted over the laser outlet before attaching the application speculum. With this device the laser beam is blocked entirely. 2. Phase I (vaginal) Renovalase™ mode with (a) fluence of 5,5J/cm2, (b) SMOOTHTM mode frequency 1.6 Hz, and (c) spot size 7 mm. 3. Phase II (vestibulum and introitus) Renovalase™ mode with (a) fluence 1,5 J/cm2, (b) SMOOTHTM mode frequency 1.6Hz, and (c) spot size 7 mm.

Device: intravaginal laser

Interventions

intravaginal laser DEVICE

application of intravaginal laser

Fotona Smooth erbium:YAG laser; Mona Lisa Touch CO2 laser; sham treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recruited participants will meet all of these criteria:
• a history of breast cancer
• premenopausal at diagnosis of breast cancer
• using AI as an adjuvant treatment
• moderate to severe symptoms of GSM (VAS ≥ 4/10)
• currently menopausal, which can be either biochemical menopause as confirmed after chemotherapy, surgical or medicinally induced (GnRH analogues for the duration of the trial)

You may not qualify if:

• Not willing to abstain from vaginal intercourse for 1 week following laser therapy
• Acute urinary or genital tract infections
• A history of genital fistula, a thin rectovaginal septum as determined by the investigator, or history of fourth degree laceration
• Prolapse ≥ grade 2 according to the Pelvic Organ Prolapse Quantification System
• Previous vaginal mesh implantation
• Abnormal result in the last cervical smear (maximum 36 month before enrollment)
• Vaginal stenosis that does not allow the placement of the laser probe
• Any condition that could interfere with study compliance

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Flemish Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Susanne Housmans, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Housmans, MD

CONTACT

+3216332211; susanne.housmans@uzleuven.be

Jan Deprest, PhD

CONTACT

+3216332211; jan.deprest@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participant and outcome assessor are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 parallel arms of equal size, participants can cross over after 3 initial treatments

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: February 6, 2023
• Study Start: December 27, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)