Clinical trial NCT05631665: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dyspareunia
Menopause
Sexual Activity
Atrophy Vulva
Keywords: Fractional CO2 Laser
Vaginal Dryness
Vulvovaginal Atrophy
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 1
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients who are in the postmenopausal period and undergo laser treatment for sexual problems
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: survey results before laser treatment
timeFrame: 6 months
measure: survey results after laser treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,
Study officials:
References: