Genital Laser Treatment in Postmenopausal Patients

NCT ID: NCT05631665

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2025-12-01

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.

Conditions

Dyspareunia; Menopause; Sexual Activity; Atrophy Vulva

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

postmenopausal women

women with postmenopausal sexual function problems will be the study arm

Group Type: EXPERIMENTAL

Survey results before and after laser treatment

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pınar Kadirogulları

Pinar KADIROGULLARI Assoc.Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ATADEK/2022.11

Identifier Type: -

Identifier Source: org_study_id