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Trial Title:
Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors
NCT ID:
NCT06007027
Condition:
Genitourinary Syndrome of Menopause
Conditions: Official terms:
Syndrome
Conditions: Keywords:
laser
mamma cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy
Description:
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withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.
Arm group label:
Active laser group
Arm group label:
Sham laser group
Summary:
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Obstetrics and Gynaecology, Randers Regional Hospital
Address:
City:
Randers
Zip:
8930
Country:
Denmark
Contact:
Last name:
Sine Jacobsen
Email:
sinjac@rm.dk
Contact backup:
Phone:
+4578421069
Start date:
March 1, 2024
Completion date:
July 30, 2025
Lead sponsor:
Agency:
University of Aarhus
Agency class:
Other
Source:
University of Aarhus
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06007027
