Effect of Hybrid Laser 10600+1540 nm on GSM

Last updated: May 17, 2019
Sponsor: Quanta System, S.p.A.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginal Atrophy

Vaginitis

Treatment

N/A

Clinical Study ID

NCT03956563
YLMT_VAG
  • Ages 45-65
  • Female

Study 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

Inclusion Criteria:

  1. Menopausal women (defined as ³1 year without menstruation until 65 years of age and nomore than 10 years within the menopause) with at least 1 GSM symptom (vaginal dryness,burning, itching or dyspareunia ) Atrophic vaginal epithelium measured with the VMVvalues of 0-49%

  2. To have any of the urinary symptoms: urgency, frequency, nocturia and urinaryincontinence 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 thequestionnaires of quality of life and with cooperative attitude.

Exclusion

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 beforethe 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 floorrehabilitation 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 Design

Total Participants: 30
Study Start date:
May 15, 2019
Estimated Completion Date:
August 15, 2020

Connect with a study center

  • Obstetrician & Gynecologist Hospital Universitario Sant Joan de Reus

    Reus, 43204
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.