Effect of Hybrid Laser 10600+1540 nm on GSM
- Conditions
- Genitourinary DiseaseVaginal Atrophy
- Interventions
- Device: Youlaser MT Group 1Device: Youlaser MT Group 2
- Registration Number
- NCT03956563
- Lead Sponsor
- Quanta System, S.p.A.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 30
- 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%
- To have any of the urinary symptoms: urgency, frequency, nocturia and urinary incontinence as symptoms of GSM
- Women able to understand , accept and signed the Informed Consent.
- Women with adequate physical and mental ability to understand and complete the questionnaires of quality of life and with cooperative attitude.
- VMV 50-64% (moderate) 65-100% (high estrogenic effect on the vaginal epithelium)
- Impossibility of introducing the laser device
- History or other energy-based vaginal therapy within 6 months prior to enrollment.
- Being on hormone replacement therapy to relieve menopausal symptoms 3 months before the study.
- Being on regular and effective topical estrogen therapy within the last 3 months.
- Being on concomitant anticoagulants therapy .
- Patients suffering of epileptic attacks and immunosuppressive diseases.
- Daily and effective use of moisturizers, lubricants or probiotics.
- Previous pelvic radiotherapy or brachytherapy
- Gynecologic or rectal cancer less than 5 years ago
- Breast cancer with antiestrogenic therapy
- Bladder emptying dysfunction.
- Women operated on UI.
- Subjects undergoing conservative supervised treatment, such as pelvic floor rehabilitation exercises.
- Genital prolapse grade III or higher, according to the simplified POPQ classification.
- Being on effective pharmacological treatment for overactive bladder.
- Taking diuretics.
- Patients with neurological diseases (Multiple Sclerosis, spinal cord injury, stroke, Parkinson's)
- Insulin-dependent diabetes mellitus (IDDM) or non-dependent insulin poorly controlled.
- Body Mass Index (BMI) > 40 kg/m2
- Active urinary tract infection
- Hematuria.
- Women who present active or recurrent genital herpes.
- Undiagnosed metrorrhagia
- Abnormal last cervical cytology
- Developmental disability, cognitive impairment and/or serious mental health illness.
- Language barrier.
- Women who refuse to participate in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active treatment arm Youlaser MT Group 1 Youlaser MT: sequential 10600+1540 nm with vaginal (2 passes) and intritus (1 pass) treatment Control arm Youlaser MT Group 2 Youlaser MT: no laser emission with vaginal (2 passes) and intritus (1 pass) treatment
- Primary Outcome Measures
Name Time Method Atrophic vaginal epithelium change 3 months and 9 months post laser treatments 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.
- Secondary Outcome Measures
Name Time Method Treatment area success for GSM #1 3 months and 9 months post laser treatments Change to vaginal pH\<5
Treatment area success for GSM #2 3 months and 9 months post laser treatments 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).
Treatment area success for Urinary incontinence #1 3 months and 9 months post laser treatments 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.Patient Global Impression 3 months and 9 months post laser treatments Score in the Patient Global Impression of Improvement, as better and much better.
Safety evaluation 61 days (at each treatment) Each of the following safety outcome variables recorded across study duration will be assessed
1. Pain rating during and after laser treatment.
2. Frequence and severity of potential adverse effects.Treatment area success for Urinary incontinence #2 3 months and 9 months post laser treatments Change in Sandvick test score from moderate to mild incontinence, or from mild to nil incontinence.
Treatment area success for Urinary incontinence #3 3 months and 9 months post laser treatments Decrease in the GSM urinary symptoms for dysuria and nocturia on VAS sclae 0-10
Patient Satisfaction 3 months and 9 months post laser treatments Score in the degree of patient satisfaction, as satisfied and very satisfied.
Trial Locations
- Locations (1)
Obstetrician & Gynecologist Hospital Universitario Sant Joan de Reus
🇪🇸Reus, Spain