Effect of Hybrid Laser 10600+1540 nm on GSM

Vaginal Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03956563
• Other study ID #: YLMT_VAG
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: August 15, 2020

Study information

• Verified date: May 2019
• Source: Quanta System, S.p.A.
• Contact: Juan Salinas Peña, MD
• Phone: +34 34 977 310 300
• Email: jrsalinas2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Genitourinary Disease
• Vaginal Atrophy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Obstetrician & Gynecologist Hospital Universitario Sant Joan de Reus	Reus

Sponsors (1)

Lead Sponsor	Collaborator
Quanta System, S.p.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Treatment area success for GSM #1	Change to vaginal pH<5	3 months and 9 months post laser treatments
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient Global Impression	Score in the Patient Global Impression of Improvement, as better and much better.	3 months and 9 months post laser treatments
Secondary	Patient Satisfaction	Score in the degree of patient satisfaction, as satisfied and very satisfied.	3 months and 9 months post laser treatments
Secondary	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)