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NCT Number: NCT06007027

Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

This project will be based on three studies over a period on three years. The first study is a dose response study that includes 30 breast cancer survivors. They will receive a total of 5 laser treatments with 4-6 weeks intervals The second study is a double-blind randomized controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active intervention and 30 will receive placebo laser treatment and act as controls. Based on the results of the dose response study, a treatment consists of three to five laser treatments every 3 weeks. The third and last study is a one-year follow-up on study two. The conditions are evaluated before and after each treatment by questionnaires, vaginal fluid pH values, punch biopsies and vaginal and urine microbiome. The studies is conducted at the Department of Obstetrics and Gynaecology at Randers Regional Hospital in collaboration with Department of Obstetrics and Gynaecology and Department of Oncology at Aarhus University Hospital.

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Key information

Conditions

Genitourinary Syndrome of Menopause

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynaecology, Randers Regional Hospital

Randers, 8930, Denmark

Location status: Recruiting

Location contact

Sine Jacobsen

CONTACT

[email protected]

CONTACT

+4578421069

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Breast cancer survivor in endocrine therapy
  • Symptomatic genitourinary symdrom of menopause with vaginal discomfort and/or dyspareunia
  • Able to read and understand Danish
  • Able to give written informed consent

Exclusion criteria

  • Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification staging system
  • Use of non-hormonal/hormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively)
  • Use of Chemotherapy (6 months prior to the baseline visit)
  • Acute urinary tract infection or active genital infection
  • History of vaginal reconstructive surgery

Treatment and study plan

SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy

Device

The laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.

Primary outcomes

  1. Vaginal dryness

    Time frame: Symptom data is collected at baseline visit and one month after the last treatment

    Participant are asked to complete the 10-cm visual analog scale (VAS) ranging for 0 to 10, with higher score indicating worse vaginal dryness.

Secondary outcomes

  1. Change in vaginal pain, itching and soreness

    Time frame: Symptom data is collected at baseline visit and one month after the last treatment

    Evaluated with visual analog scale for vaginal pain, itching, soreness. 10-cm visual analog scale (VAS) ranging for 0 to 10, with higher score indicating worse symptoms.

  2. Female Sexual Function Index

    Time frame: Symptom data is collected at baseline visit and one month after the last treatment

    Sexual function parameters; desire, arousal, lubrication, orgasm, satisfaction and pain. Range 2-36, the threshold of 26.55 indicates sexual dysfunction

  3. Sexual complaint screener - women

    Time frame: Symptom data is collected at baseline visit and one month after the last treatment

    Addressing all domains of sexual dysfunction. Range 0-60, higher score indicate increased symptom severity

  4. Urogenital Distress Inventory

    Time frame: Symptom data is collected at baseline visit and one month after the last treatment

    For urinary symptoms; irritative symptoms, obstructive/discomfort and stress symptoms. Range 0-18, higher score indicate higher disability

  5. International Consultation on Incontinence Questionnaire Female Urinary Tract Symptoms Sex

    Time frame: Symptom data is collected at baseline visit and one month after the last treatment

    Evaluation of female sexual matters associated with their lower urinary tract symptoms. Range 0-14, higher values indicating increased symptom severity.

  6. Vaginal health index

    Time frame: Vaginal health index is evaluated at baseline visit and one month after the last treatment

    subjective scoring of moisture, fluid volume, epithelial integrity and elasticity and objective scoring of pH. Range 5-25, higher scores indicate better health

  7. Vaginal biopsy

    Time frame: Vaginal biopsy is collected at baseline visit and one month after the last treatment

    The biopsy of 4*4 mm is taken from the lateralt vaginal wall, 2-3 cm from inotroitus. Afterwards fixated i formalin and the processed for light microsopy by a specialized gynaecological pathologist reporting on the changes in the histology of vaginal epithel and lamina propria.

  8. Vaginal and urinary microbiota

    Time frame: Vaginal and urine microbiota are collected at baseline visit and one month after the last treatment

    One polyester swap (FLOQSwab) is used to sample mid-vagina for microbial analysis and immediately been placed at - 80 °C until further processing. Urine is collected in a 50 mL collection tube using the clean catch method for women. Afterwards aliquoted into 10 mL fractions and immediately been placed at - 80 °C until further processing.

    DNA is isolated from samples using standard DNA isolation kits and microbiota composition determined using 16S rRNA gene sequencing. Microbiota composition is compared between groups and over time based on alpha- and beta-diversity measures, as well as changes in relative abundances of individual bacteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Pinar Bor

CONTACT

Sine Jacobsen, MD

CONTACT

[email protected]

+4578421069

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Vaginal Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors - A Randomized, Blinded, Placebo-controlled Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 23, 2023
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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