Effect of Hybrid Laser 10600+1540 nm on GSM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2020-08-15

Brief Summary

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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:

1. Confirm the performance of 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 9 months post-laser treatment, and compare it with the results at 3 months.
2. Evaluate the improvement of the GSM urinary symptoms and urinary incontinence (UI) and their impact on the Quality of Life, at each timepoint after the first laser treatment.
3. To assess the Patient's Global Impression of Improvement (PGI) with the laser treatment

* For the GSM symptoms
* For the urinary symptoms and UI
4. To assess the patient's satisfaction with the laser treatment.

* For the GSM symptoms
* For the urinary symptoms and UI.

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Detailed Description

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Conditions

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Vaginal Atrophy Genitourinary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active treatment arm

Youlaser MT: sequential 10600+1540 nm with vaginal (2 passes) and intritus (1 pass) treatment

Group Type ACTIVE_COMPARATOR

Youlaser MT Group 1

Intervention Type DEVICE

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.

Control arm

Youlaser MT: no laser emission with vaginal (2 passes) and intritus (1 pass) treatment

Group Type SHAM_COMPARATOR

Youlaser MT Group 2

Intervention Type DEVICE

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.

Interventions

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Youlaser MT Group 2

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.

Intervention Type DEVICE

Youlaser MT Group 1

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 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%
2. To have any of the urinary symptoms: urgency, frequency, nocturia and urinary incontinence as symptoms of GSM
3. Women able to understand , accept and signed the Informed Consent.
4. Women with adequate physical and mental ability to understand and complete the questionnaires of quality of life and with cooperative attitude.

Exclusion Criteria

1. VMV 50-64% (moderate) 65-100% (high estrogenic effect on the vaginal epithelium)
2. Impossibility of introducing the laser device
3. History or other energy-based vaginal therapy within 6 months prior to enrollment.
4. Being on hormone replacement therapy to relieve menopausal symptoms 3 months before the study.
5. Being on regular and effective topical estrogen therapy within the last 3 months.
6. Being on concomitant anticoagulants therapy .
7. Patients suffering of epileptic attacks and immunosuppressive diseases.
8. Daily and effective use of moisturizers, lubricants or probiotics.
9. Previous pelvic radiotherapy or brachytherapy
10. Gynecologic or rectal cancer less than 5 years ago
11. Breast cancer with antiestrogenic therapy
12. Bladder emptying dysfunction.
13. Women operated on UI.
14. Subjects undergoing conservative supervised treatment, such as pelvic floor rehabilitation exercises.
15. Genital prolapse grade III or higher, according to the simplified POPQ classification.
16. Being on effective pharmacological treatment for overactive bladder.
17. Taking diuretics.
18. Patients with neurological diseases (Multiple Sclerosis, spinal cord injury, stroke, Parkinson's)
19. Insulin-dependent diabetes mellitus (IDDM) or non-dependent insulin poorly controlled.
20. Body Mass Index (BMI) \> 40 kg/m2
21. Active urinary tract infection
22. Hematuria.
23. Women who present active or recurrent genital herpes.
24. Undiagnosed metrorrhagia
25. Abnormal last cervical cytology
26. Developmental disability, cognitive impairment and/or serious mental health illness.
27. Language barrier.
28. Women who refuse to participate in the study.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No