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The Use of Laser in the Treatment of Atrophic Vulvovaginitis

Primary Purpose

Lasers, Atrophy of Vagina, Atrophy Vulva

Status
Terminated
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Laser diiodo
Laser Placebo
Sponsored by
Hospital Italiano de Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lasers

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Menopause women with vulvovaginal symptoms of atrophy
  • No previous estrogen treatment for the last 30 days
  • Active sexual life (vaginal penetration)
  • Accept to participate
  • Pap atrophy or hypotrophy in the last year

Exclusion Criteria:

  • Vulvovaginal diseases
  • Abnormal uterine bleeding
  • Antidepressants drugs
  • Uncontrolled diabetes
  • Cervical intraepithelial lesions or cancer
  • Photosensitized or under treatment with photosensibilized drugs
  • Collagen diseases
  • Vulvovaginal infections in the last 15 days
  • Immunosuppressed patients or under immunosuppressed treatments

Sites / Locations

  • Hospital Italiano de Buenos Aires

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1 - Laser intervention

2 - Laser placebo

Arm Description

Laser diiodo treatment, 3 procedures of 5-10 minutes at intervals of 4 weeks

Only the laser speculum is placed in the vagina but the laser is not activated. 3 procedures of 5-10 minutes at intervals of 4 weeks

Outcomes

Primary Outcome Measures

Change from Baseline in Female Sexual Function Index questionnaire
Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome
Change from Baseline in Female Sexual Function Index questionnaire
Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome
Change from Baseline in Female Sexual Function Index questionnaire
Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome
Vaginal Cytology Improvement
Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy
Vaginal Cytology Improvement
Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy
Vaginal Cytology Improvement
Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy
Change in vaginal acidity measure
the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)
Change in vaginal acidity measure
the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)
Change in vaginal pH measure
the normal vaginal ph is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)

Secondary Outcome Measures

Number of patient with Local Estrogen therapy requirement post intervention
Number of patients that Need estrogen replacement for atrophy vulvovaginal symptoms, despite the intervention.This will be evaluate with a Yes/No question.

Full Information

First Posted
November 5, 2019
Last Updated
August 5, 2022
Sponsor
Hospital Italiano de Buenos Aires
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1. Study Identification

Unique Protocol Identification Number
NCT04297319
Brief Title
The Use of Laser in the Treatment of Atrophic Vulvovaginitis
Official Title
The Use of Laser in the Treatment of Atrophic Vulvovaginitis and Its Consequent Improvement in Sexual Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
This protocol was cancelled due to the COVID pandemic restrictions in our country. It was imposible to complete the recruitment of patients to achive the study objectives.
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Italiano de Buenos Aires

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the efficacy and security of laser for atrophy treatment. Half of participants will receive the laser treatment and the other half placebo.
Detailed Description
Thermal laser treatments are proposed as the newest treatments for atrophy. Through the thermal effect it would stimulates de mucosa, enhances the collagen component and the vascularization. Collagen remodeling and new collagen synthesis has been suggested as a mechanism of laser induced skin resurfacing and remodeling of vaginal connective tissue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lasers, Atrophy of Vagina, Atrophy Vulva

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind, randomized, control clinical trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The patient and the outcomes assessor and principal investigator has not access to the randomization system
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - Laser intervention
Arm Type
Experimental
Arm Description
Laser diiodo treatment, 3 procedures of 5-10 minutes at intervals of 4 weeks
Arm Title
2 - Laser placebo
Arm Type
Placebo Comparator
Arm Description
Only the laser speculum is placed in the vagina but the laser is not activated. 3 procedures of 5-10 minutes at intervals of 4 weeks
Intervention Type
Procedure
Intervention Name(s)
Laser diiodo
Intervention Description
3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks It is an outpatient procedure, not anesthesia required.
Intervention Type
Procedure
Intervention Name(s)
Laser Placebo
Intervention Description
3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks. It is an outpatient procedure, not anesthesia required.
Primary Outcome Measure Information:
Title
Change from Baseline in Female Sexual Function Index questionnaire
Description
Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome
Time Frame
baseline, and week 4 after treatment
Title
Change from Baseline in Female Sexual Function Index questionnaire
Description
Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome
Time Frame
baseline,and week 12 after treatment
Title
Change from Baseline in Female Sexual Function Index questionnaire
Description
Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome
Time Frame
baseline, and week 36 after treatment
Title
Vaginal Cytology Improvement
Description
Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy
Time Frame
baseline, and week 4 after treatment
Title
Vaginal Cytology Improvement
Description
Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy
Time Frame
baseline, and week 12 after treatment
Title
Vaginal Cytology Improvement
Description
Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy
Time Frame
baseline, and week 36 after treatment
Title
Change in vaginal acidity measure
Description
the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)
Time Frame
baseline, and week 4 after treatment
Title
Change in vaginal acidity measure
Description
the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)
Time Frame
baseline, and week 12 after treatment
Title
Change in vaginal pH measure
Description
the normal vaginal ph is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)
Time Frame
baseline,and week 36 after treatment
Secondary Outcome Measure Information:
Title
Number of patient with Local Estrogen therapy requirement post intervention
Description
Number of patients that Need estrogen replacement for atrophy vulvovaginal symptoms, despite the intervention.This will be evaluate with a Yes/No question.
Time Frame
baseline,and week 48
Other Pre-specified Outcome Measures:
Title
Number of participant with Adverse events reported in each visit
Description
It will be evaluate the number of patients that reported adverse events such as dyspareunia, irritation, edema, vaginal dryness, genital bleeding, vaginal discharge, pain, lesions
Time Frame
Baseline,and week 48

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Menopause women with vulvovaginal symptoms of atrophy No previous estrogen treatment for the last 30 days Active sexual life (vaginal penetration) Accept to participate Pap atrophy or hypotrophy in the last year Exclusion Criteria: Vulvovaginal diseases Abnormal uterine bleeding Antidepressants drugs Uncontrolled diabetes Cervical intraepithelial lesions or cancer Photosensitized or under treatment with photosensibilized drugs Collagen diseases Vulvovaginal infections in the last 15 days Immunosuppressed patients or under immunosuppressed treatments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
claudia E Marchitelli, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires, Argentina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Caba
ZIP/Postal Code
1199
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32010212
Citation
Knight C, Logan V, Fenlon D. A systematic review of laser therapy for vulvovaginal atrophy/genitourinary syndrome of menopause in breast cancer survivors. Ecancermedicalscience. 2019 Dec 12;13:988. doi: 10.3332/ecancer.2019.988. eCollection 2019.
Results Reference
background
PubMed Identifier
32099629
Citation
Adabi K, Golshahi F, Niroomansh S, Razzaghi Z, Ghaemi M. Effect of the Fractional CO2 Laser on the Quality of Life, General Health, and Genitourinary Symptoms in Postmenopausal Women With Vaginal Atrophy: A Prospective Cohort. J Lasers Med Sci. 2020 Winter;11(1):65-69. doi: 10.15171/jlms.2020.11. Epub 2020 Jan 18.
Results Reference
result

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The Use of Laser in the Treatment of Atrophic Vulvovaginitis

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