Genital Laser Treatment in Postmenopausal Patients
Primary Purpose
Dyspareunia, Menopause, Sexual Activity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Survey results before and after laser treatment
Sponsored by
About this trial
This is an interventional treatment trial for Dyspareunia focused on measuring Fractional CO2 Laser, Vaginal Dryness, Vulvovaginal Atrophy
Eligibility Criteria
Inclusion Criteria: female patients in menopause have not received previous treatment for sexual problems not receiving hormone therapy cancer vs. with no history of chemotherapy or radiotherapy patients with sound cognitive functions who can answer the questionnaire questions Exclusion Criteria: menstruating cancer treatment recipients hormone users --those who do not have sexual activity
Sites / Locations
- Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
postmenopausal women
Arm Description
women with postmenopausal sexual function problems will be the study arm
Outcomes
Primary Outcome Measures
survey results before laser treatment
Determination of sexual activity rates as points by questionnaire before laser procedure in patients with postmenopausal sexual function problems : Scoring will be done based on survey responses.
Sexual Function Index (FSFI) scoring will be used.The FSFI questionnaire consists of 19 questions; It evaluates 6 main factors as sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain/discomfort. The highest total raw score that can be obtained in this scale is 95, the lowest raw score is 4, and the highest score is 36 and the lowest score is 2 after multiplying the coefficients.
survey results after laser treatment
Determination of sexual activity rates as points by questionnaire after laser procedure in patients with postmenopausal sexual function problems.Scoring will be done based on survey responses.
Sexual Function Index (FSFI) scoring will be used.The FSFI questionnaire consists of 19 questions; It evaluates 6 main factors as sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain/discomfort. The highest total raw score that can be obtained in this scale is 95, the lowest raw score is 4, and the highest score is 36 and the lowest score is 2 after multiplying the coefficients.
Secondary Outcome Measures
Full Information
NCT ID
NCT05631665
First Posted
November 4, 2022
Last Updated
November 21, 2022
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05631665
Brief Title
Genital Laser Treatment in Postmenopausal Patients
Official Title
Evaluation of Sexual Functions After Non-ablative Er:Yag Genital Laser Treatment in Postmenopausal Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
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
Regulation of sexual functions without hormonal support in order to correct the sexual dysfunctions in women with the estrogen hormone lost in the menopausal process. Recently, the reaction to hormonal treatments and the fact that patients with a family history of breast cancer or gynecological cancer cannot receive hormonal treatment have been the reason for applying to alternative treatments. Lubricant treatments are among the treatments that patients have compliance problems in the long term and avoid due to the difficulty of application.
Correcting female sexual dysfunctions and post-menopausal women's right to want to feel sexually healthy are the most natural rights.
Because sexual dysfunctions cause physiological and psychological problems in women. Thanks to the laser treatment, it is aimed to eliminate the atrophy and sexual dysfunctions of women, thanks to the application of approximately 2 sessions without the need for long-term medication.
Detailed Description
The genitourinary syndrome of menopause (GSM) is a physiological process that affects more than 50% of postmenopausal women. It is a new definition that defines lower genital and urinary tract symptoms due to decreased estrogen levels in the menopausal transition and postmenopausal period. At the anatomical and histological level, estrogens can determine retraction of the introitus, thinning and regression of the labia, prominence of the urethral meatus, thinning of the vaginal epithelium and lamina propria layers with decreased glycogen stores, reduction in the papillae, and vascularization. Common symptoms of GSM include vaginal burning, itching, dryness, decreased lubrication, irritation, and dyspareunia. It may also include urinary symptoms such as urgency and dysuria.
Vaginal moisturizers, continuous sexual activity and lubricants are recommended as first-line treatment by the North American Menopause Society and The Endocrine Society in the treatment of GSM. When these first-line treatments are inadequate, local estrogen therapy or selective estrogen receptor modulators may be considered for suitable candidates. According to the International Urogynecological Association document, low-dose vaginal estrogens resulted in a level of evidence 1 for safe and effective treatment of GSM symptoms. In the last few years, increasing research has focused on alternative treatments such as energy-based devices and the use of laser (i.e., fractional microablative CO2, Er:YAG laser) while various studies are reassuring about the side effects of these treatments, long-term side effects remain to be defined. Previous studies have shown that fractional carbon dioxide (CO2) laser is effective and safe in improving vaginal symptoms associated with GSM. The use of this device should be done safely by trained health professionals, with certified devices, in exact indications, ideal conditions according to contraindications. The aim of the study was to evaluate the efficacy of laser therapy with CO2 vaginal laser on GSM symptoms with a prospective approach based on quality of life questionnaires completed by treated patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspareunia, Menopause, Sexual Activity, Atrophy Vulva
Keywords
Fractional CO2 Laser, Vaginal Dryness, Vulvovaginal Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients who are in the postmenopausal period and undergo laser treatment for sexual problems
Masking
None (Open Label)
Masking Description
The group of patients who are in the postmenopausal period and undergo laser treatment for sexual problems.
Laser will be applied to the postmenopausal patient group with vaginal dryness and dyspareunia complaints. This group will form the study group. The same surveys will be made before and after the procedure in the 1st month, 3rd month and 6th month. According to the results of the survey, the rate of improvement in sexual problems will be studied.
Allocation
N/A
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
postmenopausal women
Arm Type
Experimental
Arm Description
women with postmenopausal sexual function problems will be the study arm
Intervention Type
Other
Intervention Name(s)
Survey results before and after laser treatment
Intervention Description
Determination of sexual activity rates as points with a questionnaire before and after laser treatment for patients with postmenopausal sexual function problems.
Primary Outcome Measure Information:
Title
survey results before laser treatment
Description
Determination of sexual activity rates as points by questionnaire before laser procedure in patients with postmenopausal sexual function problems : Scoring will be done based on survey responses.
Sexual Function Index (FSFI) scoring will be used.The FSFI questionnaire consists of 19 questions; It evaluates 6 main factors as sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain/discomfort. The highest total raw score that can be obtained in this scale is 95, the lowest raw score is 4, and the highest score is 36 and the lowest score is 2 after multiplying the coefficients.
Time Frame
6 months
Title
survey results after laser treatment
Description
Determination of sexual activity rates as points by questionnaire after laser procedure in patients with postmenopausal sexual function problems.Scoring will be done based on survey responses.
Sexual Function Index (FSFI) scoring will be used.The FSFI questionnaire consists of 19 questions; It evaluates 6 main factors as sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain/discomfort. The highest total raw score that can be obtained in this scale is 95, the lowest raw score is 4, and the highest score is 36 and the lowest score is 2 after multiplying the coefficients.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
female patients in menopause
have not received previous treatment for sexual problems
not receiving hormone therapy
cancer vs. with no history of chemotherapy or radiotherapy
patients with sound cognitive functions who can answer the questionnaire questions
Exclusion Criteria:
menstruating
cancer treatment recipients
hormone users --those who do not have sexual activity
Facility Information:
Facility Name
Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Genital Laser Treatment in Postmenopausal Patients
We'll reach out to this number within 24 hrs