Efficacy and Safety of the Neodymium Laser in Treatment of Urogenital Tract Diseases in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in vaginal dryness from baseline
研究概览
简要总结
Study objective: To evaluate the efficacy and safety of the Magic Max neodymium laser in the medical treatment of women with symptoms of genitourinary syndrome of menopausal, vulvar lichen sclerosus and pelvic floor muscle reduction.
详细描述
Study objective: To evaluate the efficacy and safety of the Magic Max neodymium laser in the medical treatment of women with symptoms of genitourinary syndrome of menopausal, vulvar lichen sclerosus and pelvic floor muscle reduction.
Materials and methods
60 patients with diseases of the urogenital tract were enrolled into the study; they were treated with a neodymium (ND) laser: three 20-minute sessions every 28 ± 2 days. Efficacy was assessed by means of the Female Sexual Function Index (FSFI), ICIQ-SF, PISQ-12, SF36 survey forms, and a questionnaire to identify urinary disorders at the following time points: before treatment, one month after each session and 6 months after the last procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 29 Years 至 72 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diseases of the urogenital tract
- •symptoms of genitourinary menopausal syndrome,
- •vulvar lichen sclerosus
- •pelvic floor muscle reduction
- •Exclusion criteria:
- •pregnancy
- •oncological diseases
排除标准
- 未提供
结局指标
主要结局
Change in vaginal dryness from baseline
时间窗: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.
Efficacy was assessed by SF36 quality of life survey form means of the this is a non-specific questionnaire for assessing the patient's quality of life.When 1 point-is the highest result (best),5 points-this is the lowest result (worst).
Change in frequency of involuntary urination (urinary incontinence) from baseline
时间窗: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.
The effectiveness was assessed using ICIQ-SF (International Urine Retention Index), a subjective indicator of the severity of urine loss and quality of life in patients with urinary incontinence, using the format of questions on a 5-point Likert scale to assess the presence, severity and concomitant symptoms. This is a subjective indicator designed to assess the level, impact and suspected cause of urinary incontinence on the quality of life.5 points-the highest score of the result,0 point- the lowest score of the result.The total amount of points for answering the questions where 0 points - a slight degree of urinary incontinence,19 - 21 - very severe urinary incontinence.
Change in frequency of involuntary urination during physical activities (stress urinary incontinence).
时间窗: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.
Efficacy was assessed by means of the PISQ12 is a specific and reliable questionnaire consisting of three sections: behavioral and emotional characteristics, physical aspects and questions concerning the patient's relationship with a partner.Each item of the questionnaire contains five possible answers,which are evaluated in points.The result of the survey is expressed by the sum of points on all points.The maximum number of points is48,which is an indicator of the best sexual function. SF36 quality of life survey form means of the this is a non-specific questionnaire for assessing the patient's quality of life.When 1 point-is the highest result (best),5 points-this is the lowest result (worst)
次要结局
- Change in burning pain in the vagina from baseline(Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.)
研究者
Pauzina Olga Alexandrovna
Head of the Outpatient Department of the Volga District Medical Center of the FMBA of Russia, Principal Investigator
1st Federal Budgetary Healthcare Institution Volga District Medical Center