Clinical trial NCT03956563: Effect of Hybrid Laser 10600+1540 nm on GSM
Official title: Effect of Hybrid Laser 10600+1540 nm on Vaginal Atrophy-genitourinary Syndrome of the Menopause
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Atrophy
Genitourinary Disease
Lead sponsor: Quanta System, S.p.A.
Sponsor class: INDUSTRY
First posted: 2019-05-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Atrophic vaginal epithelium change
timeFrame: 3 months and 9 months post laser treatments
Secondary outcomes:
measure: Treatment area success for GSM #1
timeFrame: 3 months and 9 months post laser treatments
measure: Treatment area success for GSM #2
timeFrame: 3 months and 9 months post laser treatments
measure: Treatment area success for Urinary incontinence #1
timeFrame: 3 months and 9 months post laser treatments
measure: Treatment area success for Urinary incontinence #2
timeFrame: 3 months and 9 months post laser treatments
measure: Treatment area success for Urinary incontinence #3
timeFrame: 3 months and 9 months post laser treatments
measure: Patient Global Impression
timeFrame: 3 months and 9 months post laser treatments
measure: Patient Satisfaction
timeFrame: 3 months and 9 months post laser treatments
measure: Safety evaluation
timeFrame: 61 days (at each treatment)
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Obstetrician & Gynecologist Hospital Universitario Sant Joan de Reus
Study officials:
References: