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临床试验/NCT05631665
NCT05631665进行中(未招募)不适用

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

Kanuni Sultan Suleyman Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 1 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1
试验地点
2
主要终点
survey results before laser treatment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

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.

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • menstruating
  • cancer treatment recipients
  • hormone users --those who do not have sexual activity

结局指标

主要结局

survey results before laser treatment

时间窗: 6 months

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

时间窗: 6 months

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pınar Kadirogulları

Pinar KADIROGULLARI Assoc.Prof

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (2)

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