Genital Laser Treatment in Postmenopausal Patients

Menopause Clinical Trial

Official title:

Evaluation of Sexual Functions After Non-ablative Er:Yag Genital Laser Treatment in Postmenopausal Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05631665
• Other study ID #: ATADEK/2022.11
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2022
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Atrophy Vulva
• Dyspareunia
• Menopause
• Sexual Activity

Intervention

Other:
• Survey results before and after laser treatment
Determination of sexual activity rates as points with a questionnaire before and after laser treatment for patients with postmenopausal sexual function problems.

Locations

Country	Name	City	State
Turkey	Acibadem University Atakent Hospital, Department of Obstetrics and Gynecology,	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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.	6 months