Effect of Hybrid Laser 10600+1540 nm on GSM

Effect of Hybrid Laser 10600+1540 nm on Vaginal Atrophy-genitourinary Syndrome of the Menopause

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.

Study Overview

• Status: Unknown
• Conditions: Vaginal Atrophy; Genitourinary Disease
• Intervention / Treatment: Device: Youlaser MT Group 1; Device: Youlaser MT Group 2

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Salinas Peña, MD; Phone Number: +34 34 977 310 300; Email: jrsalinas2@gmail.com

Study Locations

• Spain
  • Reus, Spain, 43204
    • Recruiting
    • Obstetrician & Gynecologist Hospital Universitario Sant Joan de Reus
    • Contact: Juan Salinas Peña, MD.; Phone Number: + 34 977 310 300; Email: jrsalinas2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active treatment arm; Youlaser MT: sequential 10600+1540 nm with vaginal (2 passes) and intritus (1 pass) treatment	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.
Sham Comparator: Control arm; Youlaser MT: no laser emission with vaginal (2 passes) and intritus (1 pass) treatment	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment area success for GSM #1	Change to vaginal pH<5	3 months and 9 months post laser treatments
Treatment area success for GSM #2	Decrease in the GSM symptoms on VAS scale 0-10. vaginal dryness, burning, itching, and dyspareunia,dysuria (0: complete absence of symptoms, 10: worst possible symptoms).	3 months and 9 months post laser treatments
Treatment area success for Urinary incontinence #1	Change in ICIQ-SF score from moderate to mild incontinence, or from mild to nil incontinence. Improve the quality of life related to incontinence by decreasing the score in the interference with everydays life question.	3 months and 9 months post laser treatments
Treatment area success for Urinary incontinence #2	Change in Sandvick test score from moderate to mild incontinence, or from mild to nil incontinence.	3 months and 9 months post laser treatments
Treatment area success for Urinary incontinence #3	Decrease in the GSM urinary symptoms for dysuria and nocturia on VAS sclae 0-10	3 months and 9 months post laser treatments
Patient Global Impression	Score in the Patient Global Impression of Improvement, as better and much better.	3 months and 9 months post laser treatments
Patient Satisfaction	Score in the degree of patient satisfaction, as satisfied and very satisfied.	3 months and 9 months post laser treatments
Safety evaluation	Each of the following safety outcome variables recorded across study duration will be assessed; Pain rating during and after laser treatment.; Frequence and severity of potential adverse effects.	61 days (at each treatment)

Collaborators and Investigators

• Sponsor: Quanta System, S.p.A.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Anticipated): May 15, 2020
• Study Completion (Anticipated): August 15, 2020

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: YLMT_VAG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No