Back to resultsEffect of Hybrid Laser 10600+1540 nm on GSM
Primary Purpose
Vaginal Atrophy, Genitourinary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Youlaser MT Group 2
Youlaser MT Group 1
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Atrophy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Obstetrician & Gynecologist Hospital Universitario Sant Joan de ReusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active treatment arm
Control arm
Arm Description
Youlaser MT: sequential 10600+1540 nm with vaginal (2 passes) and intritus (1 pass) treatment
Youlaser MT: no laser emission with vaginal (2 passes) and intritus (1 pass) treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Treatment area success for GSM #1
Change to vaginal pH<5
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).
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.
Treatment area success for Urinary incontinence #2
Change in Sandvick test score from moderate to mild incontinence, or from mild to nil incontinence.
Treatment area success for Urinary incontinence #3
Decrease in the GSM urinary symptoms for dysuria and nocturia on VAS sclae 0-10
Patient Global Impression
Score in the Patient Global Impression of Improvement, as better and much better.
Patient Satisfaction
Score in the degree of patient satisfaction, as satisfied and very satisfied.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03956563
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
May 15, 2020 (Anticipated)
Study Completion Date
August 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Quanta System, S.p.A.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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:
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.
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.
To assess the Patient's Global Impression of Improvement (PGI) with the laser treatment
For the GSM symptoms
For the urinary symptoms and UI
To assess the patient's satisfaction with the laser treatment.
For the GSM symptoms
For the urinary symptoms and UI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Atrophy, Genitourinary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active treatment arm
Arm Type
Active Comparator
Arm Description
Youlaser MT: sequential 10600+1540 nm with vaginal (2 passes) and intritus (1 pass) treatment
Arm Title
Control arm
Arm Type
Sham Comparator
Arm Description
Youlaser MT: no laser emission with vaginal (2 passes) and intritus (1 pass) treatment
Intervention Type
Device
Intervention Name(s)
Youlaser MT Group 2
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Youlaser MT Group 1
Intervention Description
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.
Primary Outcome Measure Information:
Title
Atrophic vaginal epithelium change
Description
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.
Time Frame
3 months and 9 months post laser treatments
Secondary Outcome Measure Information:
Title
Treatment area success for GSM #1
Description
Change to vaginal pH<5
Time Frame
3 months and 9 months post laser treatments
Title
Treatment area success for GSM #2
Description
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).
Time Frame
3 months and 9 months post laser treatments
Title
Treatment area success for Urinary incontinence #1
Description
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.
Time Frame
3 months and 9 months post laser treatments
Title
Treatment area success for Urinary incontinence #2
Description
Change in Sandvick test score from moderate to mild incontinence, or from mild to nil incontinence.
Time Frame
3 months and 9 months post laser treatments
Title
Treatment area success for Urinary incontinence #3
Description
Decrease in the GSM urinary symptoms for dysuria and nocturia on VAS sclae 0-10
Time Frame
3 months and 9 months post laser treatments
Title
Patient Global Impression
Description
Score in the Patient Global Impression of Improvement, as better and much better.
Time Frame
3 months and 9 months post laser treatments
Title
Patient Satisfaction
Description
Score in the degree of patient satisfaction, as satisfied and very satisfied.
Time Frame
3 months and 9 months post laser treatments
Title
Safety evaluation
Description
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.
Time Frame
61 days (at each treatment)
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Salinas Peña, MD
Phone
+34 34 977 310 300
Email
jrsalinas2@gmail.com
Facility Information:
Facility Name
Obstetrician & Gynecologist Hospital Universitario Sant Joan de Reus
City
Reus
ZIP/Postal Code
43204
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Salinas Peña, MD.
Phone
+ 34 977 310 300
Email
jrsalinas2@gmail.com
12. IPD Sharing Statement
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Effect of Hybrid Laser 10600+1540 nm on GSM
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