Effect of Hybrid Laser 10600+1540 nm on GSM
1 other identifier
interventional
30
1 country
1
Brief Summary
The primary objective of the study is to clinically confirm, by comparison with a control group, the performance of the 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 3 months after the last laser treatment. The secondary objectives are:
- For the GSM symptoms
- For the urinary symptoms and UI
- To assess the patient's satisfaction with the laser treatment.
- For the GSM symptoms
- For the urinary symptoms and UI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2019
CompletedStudy Start
First participant enrolled
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2020
CompletedMay 20, 2019
May 1, 2019
1 year
May 15, 2019
May 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Atrophic vaginal epithelium change
The primary efficacy outcome measure in this study is to obtain on the atrophic vaginal epithelium at 3 months after the last laser treatment, values going from absent/low estrogenization (0-49%) to moderate or high estrogenization (50-64%) measured with VMV. The results will be compared between the treatment and the control arm.
3 months and 9 months post laser treatments
Secondary Outcomes (8)
Treatment area success for GSM #1
3 months and 9 months post laser treatments
Treatment area success for GSM #2
3 months and 9 months post laser treatments
Treatment area success for Urinary incontinence #1
3 months and 9 months post laser treatments
Treatment area success for Urinary incontinence #2
3 months and 9 months post laser treatments
Treatment area success for Urinary incontinence #3
3 months and 9 months post laser treatments
- +3 more secondary outcomes
Study Arms (2)
Active treatment arm
ACTIVE COMPARATORYoulaser MT: sequential 10600+1540 nm with vaginal (2 passes) and intritus (1 pass) treatment
Control arm
SHAM COMPARATORYoulaser MT: no laser emission with vaginal (2 passes) and intritus (1 pass) treatment
Interventions
Youlaser MT is a laser device including two laser sources emitting at 10600 nm (CO2) and 1540 nm (Ga-As) intended to be used for gynaecological applications. Each patient in the control arm will receive 3 simulated laser treatments every 30 days. A placebo consists in a sham device laser that simulates the acoustic signal even if it does not deliver any laser radiation to the subject.
Youlaser MT is a laser device including two laser sources emitting at 10600 nm (CO2) and 1540 nm (Ga-As) intended to be used for gynaecological applications. Each patient in the active arm will receive 3 laser treatments with the laser: one treatment administration every 30 days.
Eligibility Criteria
You may qualify if:
- Menopausal women (defined as ³1 year without menstruation until 65 years of age and no more than 10 years within the menopause) with at least 1 GSM symptom (vaginal dryness, burning, itching or dyspareunia ) Atrophic vaginal epithelium measured with the VMV values of 0-49%
- To have any of the urinary symptoms: urgency, frequency, nocturia and urinary incontinence as symptoms of GSM
- Women able to understand , accept and signed the Informed Consent.
- Women with adequate physical and mental ability to understand and complete the questionnaires of quality of life and with cooperative attitude.
You may not qualify if:
- VMV 50-64% (moderate) 65-100% (high estrogenic effect on the vaginal epithelium)
- Impossibility of introducing the laser device
- History or other energy-based vaginal therapy within 6 months prior to enrollment.
- Being on hormone replacement therapy to relieve menopausal symptoms 3 months before the study.
- Being on regular and effective topical estrogen therapy within the last 3 months.
- Being on concomitant anticoagulants therapy .
- Patients suffering of epileptic attacks and immunosuppressive diseases.
- Daily and effective use of moisturizers, lubricants or probiotics.
- Previous pelvic radiotherapy or brachytherapy
- Gynecologic or rectal cancer less than 5 years ago
- Breast cancer with antiestrogenic therapy
- Bladder emptying dysfunction.
- Women operated on UI.
- Subjects undergoing conservative supervised treatment, such as pelvic floor rehabilitation exercises.
- Genital prolapse grade III or higher, according to the simplified POPQ classification.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Obstetrician & Gynecologist Hospital Universitario Sant Joan de Reus
Reus, 43204, Spain
Related Publications (1)
Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
PMID: 40709601DERIVED
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2019
First Posted
May 20, 2019
Study Start
May 15, 2019
Primary Completion
May 15, 2020
Study Completion
August 15, 2020
Last Updated
May 20, 2019
Record last verified: 2019-05